PTC Windchill PLM Implementations & Consulting
PTC Windchill is the premier PLM software solution providing security and traceability for your intellectual property while managing every aspect of your product development and manufacturing processes. As trusted PTC Partners, SPK and Associates brings the expertise and experience needed to provide the best possible prices and the highest level of support for every PTC product. Contact us today to learn more about how we can provide licensing and implementation support.
Talk to PTC Partners and PLM Experts
PTC Windchill Success
SRAM gets 128% ROI with Windchill PLM
SRAM deployed PTC Windchill to integrate and unify the engineering processes for all its brands. The company’s rapid growth through acquisition resulted in engineering and development groups that were not able to communicate and share information across departments. The company needed a solution that would support its holistic business process approach to the creation and management of product data, with PLM integrating processes, technology and people into an information backbone to facilitate a lean enterprise.
STRATTEC Security success with Windchill PLM in 11 months
STRATTEC Security Corporation deployed PTC Windchill to replace its existing product lifecycle management (PLM) solution and improve product design tracking and collaboration. Nucleus found that PTC Windchill enables the company to increase productivity and reduced design costs and waste. Learn how STRATEC Security got 122% ROI in 11 months and an average annual benefit of over $1M.
PTC Windchill PLM Software
PTC Windchill is a family of Product Lifecycle Management software products that is offered by PTC and sold/serviced by it’s partners, such as SPK and Associates. PTC Windchill is a proven out-of-the-box PLM software solution to help manage every aspect of information about your product development and manufacturing process. Windchill acts as the single source of product information all the way up and down the organization.
PTC Windchill Capabilities & Benefits:
- Built-in integration with all major product development software including all PTC products
- Easy connectivity to other enterprise systems
- Supports distributed product development and enables real-time collaboration across firewalls
- Drives cross-enterprise understanding of complex content – regardless of source
BOM Management
Using Windchill, companies adopt a parts-centric approach to managing their Bill of Materials.
Change and Configuration Management
Windchill PLM allows you to create data governance and associativity so that all changes and configurations are fully defined and controlled.
Quality Management
Continually improve the quality of your product to reduce service costs.
Process Planning & Work Instructions
Design your product using platform structures to manage options and variants.
Product Data Management
Manage multi-CAD data in a single system using tight integration with Creo, SolidWorks, AutoCAD, and other CAD tools.
Platforms, Options & Variants
Design with platform structures and manage options and variants.
Talk with our PTC Windchill Experts
Talk with an Expert| On Prem Part Minimum Prerequisites | None | None | None | None | ||
| Registered User Part Number | SPN-CPE5651-F- | SPN-CPE5650-F- | Not Available | Not Available | ||
| Active Daily User Part Number | SPN-CPE5642-F- | SPN-CPE5641-F- | SPN-CPE5640-F- | Not Available | ||
| Kiosk Part Number | Not Available | Not Available | Not Available | SPN-CPE5644-F- | ||
| Designated Server Part Number | Not Available | Not Available | Not Available | Not Available | ||
| WC Part Name | Windchill Navigate View and Acknowledge | Windchill Navigate Enterprise Collaboration | Windchill Navigate Supplier Collaboration | Windchill Navigate Shop Floor | ||
| Find and view product information | ||||||
| Access to standard Navigate View Apps | ✅ | ✅ | ✅ | ✅ | ||
| Access to standard Navigate Contribute Apps | ✅ | ✅ | ✅ | |||
| Access to standard Navigate Work Instruction Delivery App | ✅ | |||||
| Search Search indexed and non-indexed content Define and execute user-specific saved searches (but not global searches) |
✅ | ✅ | ✅ | ✅ | ||
| View page content View any web page and web page content to which the viewer user is granted authorization |
✅ | ✅ | ✅ | ✅ | ||
| View and Download non-CAD content Download and view any office document content Download any pre-published derived formats (PDF, IGES, STL) Request publishing of derived formats on demand (for those supported) Can not download any native CAD formats (MCAD, ECAD…) |
✅ | ✅ | ✅ | ✅ | ||
| View reports created by others but cannot create or edit reports | ✅ | ✅ | ✅ | ✅ | ||
| View 2-D and 3-D models View thumbnails and 2-D and 3-D images images Pan, zoom, rotate Measure, section, explode View but do not create/edit annotations |
✅ | ✅ | ✅ | ✅ | ||
| Subscribe to events Subscribe to be notified of events on items to which user has access |
✅ | ✅ | ✅ | ✅ | ||
| Contribute & collaborate, Issue Identification | ||||||
| Participate in Projects | ✅ | ✅ | ✅ | ✅ | ||
| Organize Create/edit folders Create/edit links |
✅ | ✅ | ✅ | |||
| Participate in assigned tasks Workflow tasks Project tasks Action item tasks |
✅ | ✅ | ✅ | |||
| Collaborate Create topics and discussion postings Create and save annotations Create/update action items Create/attach/edit office documents (including use of Desktop Integration) Generate PDFs of Office Docs and Mark them up Create and update meetings |
✅ | ✅ | ✅ | |||
| PDF Collaboration Generate PDFs of Office Docs and Mark them up |
✅ | ✅ | ✅ | |||
| Basic Authoring of content, and release and change management | ||||||
| Create/attach/edit office documents (including use of Desktop Integration) | ✅ | ✅ | ✅ | |||
| Create, Participate, & Approve Promotion Requests | ✅ | ✅ | ✅ | |||
| Approve Change Workflow tasks | ✅ | ✅ | ✅ | |||
| Approve Design Reviews | ✅ | ✅ | ✅ | |||
| Create/update problem reports | ✅ | ✅ | ✅ | |||
| Create deviation or waiver | ✅ | ✅ | ✅ | |||
| Revise documents | ✅ | ✅ | ✅ | |||
| Create and manage collaboration projects (Does not include the ability to create and manage project plans, schedules resources) |
||||||
| Create/Edit Project Route | ||||||
| Set State | ||||||
| Create Packages | ||||||
| Add To Packages | ||||||
| Create and manage Change Reguest, Change Notice, Change Task | ||||||
| Sequence Change Tasks | ||||||
| Revise Objects (Including Docs, CAD, Parts) | ||||||
| Create Design Review | ||||||
| Create and manage baselines | ||||||
| Manage templates and attributes (documents, parts, projects, teams, lifecycles, workflows) | ||||||
| Create and manage global searches and reports | ||||||
| Configure Actions for Roles | ||||||
| Basic Creation and Mangement of Arbortext Documents (Requires Arbortext Editor) | ||||||
| Basic Creation and Mangement of Creo Illustrate & ISODraw Illustrations (Requires Creo Illustrate or ISODraw respectiviely)) | ||||||
| Project Management | ||||||
| Create and manage projects, project teams and project content | ||||||
| Create and manage project templates, team templates and project workflow templates | ||||||
| Create, execute and manage project plans with milestones, activities and tasks | ||||||
| Create and manage project resources (people, equipment, facilities…) | ||||||
| Create and manage action items, discussion forums and notebooks | ||||||
| Create and manage project reports | ||||||
| Intellectual Property Protection | ||||||
| Have content filtered from view/access based on security label values. | ✅ | ✅ | ✅ | ✅ | ||
| Abiity to set security label value upon document creation | ✅ | ✅ | ✅ | |||
| Ability to change seciroty label value on existing object | ||||||
| Create and manage security labels and classifications and control access to information based on user or group label or classification access level. | ||||||
| Create and manage agreements (such as NDA, ITAR) and control access to information based on the agreements that a user or group is covered to provide access to agreement-controled information. | ||||||
| Manage agreement creation and change through workflow process | ||||||
| Control which representations of content are available for view and download by groups/roles and users. For example, some users may be given access to native CAD formats and others will have only access to low-fidelity 2-D images or 3-D viewables. | ||||||
| Classification | ||||||
| View classification hiearchies and attributes and search for parts and documents using classifications and classification attribute ranges and values (parametric search). | ✅ | ✅ | ✅ | ✅ | ||
| Find Similar Parts Action | ||||||
| Create and update document classifications | ||||||
| Organize classifications into node hierarchies and manage hierarchies | ||||||
| Associate documents with classifications | ||||||
| Tailor specific business attributes unique to individual classification nodes | ||||||
| Define valid attribute characteristics and constraints | ||||||
| Layout and group attributes | ||||||
| Localize classification nodes and attributes for various languages | ||||||
| Associate one or more measurement system and units of measure with attributes | ||||||
| Import and export classification schema | ||||||
| Create and update part classifications | ||||||
| Associate parts with classifications | ||||||
| BOM Management | ||||||
| Create and manage product structures and engineering BOMs | ||||||
| Import BOM structure from Excel | ||||||
| Export Importable Spreadsheet | ||||||
| Create and manage product structure baselines | ||||||
| Create and manage product instances | ||||||
| Create and manage serialized products | ||||||
| "Basic" Options and Variants | ||||||
| Create and manage configurable parts and part structures | ||||||
| Add and update configurable parts to any part structure to support multiple configurations | ||||||
| Create and manage options, option pools and sets and choices and filtering | ||||||
| Define and manage rules, assigned item and usage expressions to control allowed options, choices, include, exclude and enable rules and valid configurations | ||||||
| Define parameters and values used to support structure-based optionality (in the Product Structure Explorer) | ||||||
| BOM Transformation | ||||||
| Transform an engineering BOM to a Manufacturing BOM | ||||||
| Define and manage plant specific data of Manufacturing BOM | ||||||
| Define and manage semi-finish Parts | ||||||
| Define and manage Standard Control Characteristics | ||||||
| Transform an engineering BOM to a Service BOM | ||||||
| Transform any BOM into another downstream BOM | ||||||
| Reconcile upstream changes to downstream BOM | ||||||
| Define and Maintain 3D Mocl Up of downstream BOM | ||||||
| MCAD Data Management | ||||||
| Download MCAD content | ||||||
| Automatically create and associate part BOM items with CAD documents on CAD document check in | ||||||
| Create and manage MCAD models using workgroup managers for Creo, CED, CEDD, MathCAD DM | ||||||
| Create and manage MCAD models using workgroup manager for CADDS 5 | ||||||
| Automatically publish CAD formats with included Creo View CAD adapters for all supported PTC CAD applications | ||||||
| Create and manage MCAD models using workgroup managers for Solidworks, Inventor and AutoCAD | ||||||
| Automatically publish CAD formats with included Creo View CAD adapters for Inventor and SolidWorks (native publishing is supported for AutoCAD) | ||||||
| Create and manage MCAD models using workgroup managers for NX and Catia | ||||||
| Automatically publish NX CAD formats with included Creo View CAD adapters for NX (An adapter for publishing Catia formats must be independently purchased from Theorem Solutions) | ||||||
| Manufacturing Process Management | ||||||
| Create and manage manufacturing resources | ||||||
| Create and manage process plans | ||||||
| Create and manage Work Instructions | ||||||
| Create and Manage Standard Capabilities | ||||||
| Author work instruction graphics with Creo View | ||||||
| Author work instruction graphics with Creo Illustrate | ||||||
| Platform Structure Management* | ||||||
| *At least one user in the system must have either Windchill Advanced Product Design (SPN-CPE5631-F-), or Windchill Manufacturing Process Planner (SPN-CPE5633-F-), or Windchill Service Parts (SPN-CPE5636-F-) add-on license for a customer to use any Platform Structures functionality listed in this section. | ||||||
| View Configurable parts and structure | ✅* | ✅* | ✅* | ✅* | ||
| Filter Configurable structure using Choices (Edit Filter) | ✅* | ✅* | ✅* | ✅* | ||
| Apply and existing Variant Specification to filter a structure | ✅* | ✅* | ✅* | ✅* | ||
| Configure a configurable part and create a variant | ||||||
| Define numeric choices | ||||||
| Define aliases for option choices | ||||||
| Manage and control process to govern changes to rules | ||||||
| Control what rules are applied using conditional logic (e.g., if <condition> then use Rule A/else us Rule B) and independent local rules | ||||||
| Define basic assigned occurrence expressions, advanced assigned item expressions, usage and occurrence expressions and independent assigned expressions. | ||||||
| Define and control via alternate option filtering | ||||||
| Define and manage nested products, merged option sets, product families, models and product variants | ||||||
| Import Variants and Variant specifications from a spreadsheet | ||||||
| Publish (export) platform structure information to ERP and other systems using ERP Connector | ||||||
| Programmatically load variants using variant loader APIs | ||||||
| From a generic part structure, create a configured or engineered to order structure based on a set of rules defined within the PLM system. | ||||||
| Supplier Component Management | ||||||
| *At least one user in the system must have either a Windchill Design Engineering (SAS-CPE7004-F-) OR Windchill Product Engineering (SAS-DPE7007-F-) OR Windchill Manufacturing (SAS-CPE7005-F-) OR Windchill Service Parts (SAS-CPE7011-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||||||
| View and search for supplier and supplier part information and attributes. | ✅* | ✅* | ✅* | ✅* | ||
| Create a new Part Request | ✅* | ✅* | ✅* | |||
| Define one or more vendor parts that can be used for a company’s internal part | ||||||
| Define detailed functional characteristics for supplied parts and associate with specifications and other documents | ||||||
| Manage suppliers and supplied parts through supplier and supplier part introduction process workflows | ||||||
| Manage status of manufacturers and vendors (i.e., approved, pending, obsolete) | ||||||
| Identify default supplier and supplied part preferences based on part classification and context (Requires addition of Classification - SPN-CPE5464-F ) | ||||||
| Automatically update supplier preference list using configurable rules | ||||||
| Develop predefined reports on supplier metrics | ||||||
| Create rules for part grading based on supplier, sourcing context and commodity codes or classification | ||||||
| Automatically calculate a sourcing grade for an internal part, based on an analysis of its approved manufacturer list | ||||||
| Define one or more manufacturer parts that can be used for a company’s internal part | ||||||
| Import and export supplier part information with Microsoft Excel | ||||||
| Nonconformance | ||||||
| *At least one user in the system must have Windchill Quality Management (SAS-CPE7008-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||||||
| View Nonconformance, Investigation, and Disposition | ✅* | ✅* | ✅* | ✅* | ||
| New Nonconformance - ( Initiator ) | ✅* | ✅* | ✅* | |||
| Nonconformance Management - ( manager ) | ||||||
| Nonconformance Review | ||||||
| Nonconformance Investigation - ( Investigator ) | ✅* | ✅* | ✅* | |||
| Nonconformance Disposition and MRB - ( Evaluator / Manager ) | ||||||
| Nonconformance Perform Disposition - ( Dispositioner ) | ✅* | ✅* | ✅* | |||
| Customer Experiences/Complaints | ||||||
| *At least one user in the system must have Windchill Quality Management (SAS-CPE7008-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||||||
| **The Medical Device Module add-on license is required for a customer to use any Complaints functionality listed in this section. | ||||||
| View Complaint, Investigation, and Action | ✅* | ✅* | ✅* | ✅* | ||
| View Regulatory Reports | ||||||
| New Customer Experience - ( Initiator ) | ✅* | ✅* | ✅* | |||
| Customer Experience Management - ( Manager ) | ||||||
| Customer Experience Evaluation | ||||||
| Customer Experience General Activity | ✅* | ✅* | ✅* | |||
| Customer Experience Product General Activity | ✅* | ✅* | ✅* | |||
| Customer Experience Product Investigation Activity | ✅* | ✅* | ✅* | |||
| Customer Experience Product Regulatory Activity | ||||||
| Customer Experience Review - ( Evaluator / Manager ) | ||||||
| CAPA | ||||||
| **At least one user in the system must have Windchill Quality Management (SAS-CPE7008-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||||||
| View CAPA, Confirmation, Investigation, CAPA Plan, and Action, | ü* | ü* | ü* | ü* | ||
| New CAPA Request - (Initiator ) | ü* | ü* | ü* | |||
| CAPA Management | ||||||
| CAPA Review - ( Evaluator / Manager ) | ||||||
| CAPA Investigation - ( Investigator ) | ü* | ü* | ü* | |||
| CAPA Plan - ( Evaluator / Manager ) | ||||||
| CAPA Perform Action - ( Evaluator / Manager ) | ü* | ü* | ü* | |||
| CAPA Effectiveness - ( Evaluator / Manager ) | ||||||
| Audit Management | ||||||
| *At least one user in the system must have a Windchill Audit Management (SAS-CPE7009-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||||||
| View Audit and Response | ü* | ü* | ü* | ü* | ||
| Create Schedule & Manage Internal and Exteral Audits - ( Audit Manager ) | ||||||
| Plan & Scope - ( Audit Manager ) | ||||||
| Conduct Audit - ( Audit Manager ) | ||||||
| Audit Response - ( Auditee - Responder ) | ü* | ü* | ü* | |||
| Manage Response - ( Audit Manager ) | ||||||
| Complete Audit - ( Audit Manager ) | ||||||
| Regulatory Hub | ||||||
| *At least one user in the system must have a Regulatory Hubl (SPN-CPE5569-F-) add-on license for a customer to use any Regulatory Hub functionality listed in this section. | ||||||
| View Regulatory Submissions | ü* | ü* | ü* | ü* | ||
| Create Submission - ( Regulatory Manager ) | ||||||
| Plan & Conduct Submission - ( Regulatory Manager ) | ||||||
| Add Content to Submission - ( Regulatory Contributor ) | ü* | ü* | ü* | |||
| Close Submission - ( Regulatory Manager ) | ||||||
| Document Control | ||||||
| *The Med Dev Part (nunber TBD)) add-on server license for users to access functionality listed in this section with an asterisk next to the check mark. | ||||||
| View Controlled Document | ü* | ü* | ü* | ü* | ||
| Create Controlled Document - ( Document Author ) | ü* | ü* | ü* | |||
| Revise Controlled Document - ( Document Author ) | ||||||
| Review Controled Document - ( Document Approver ) | ü* | ü* | ü* | |||
| Manage Qualified Roles - ( Document Manager ) | ||||||
| Manage Training - ( Document Manager ) | ||||||
| Complete Training - ( Document Trainee ) | ü* | ü* | ü* | ü* | ||
| Obsolete Controled Document - ( Document Manager ) | ||||||
| Design Control (** Future Release Enhancements) | ||||||
| *The Med Dev Part (nunber TBD)) add-on server license for users to access functionality listed in this section with an asterisk next to the check mark. | ||||||
| View Risk Assessment, Environmental Analysis, DHF/DMR, Requirement Artifact** | ü* | ü* | ü* | ü* | ||
| Create Requirement Artifact** - ( Product Manager ) | ||||||
| Create High Level Design WF task in Med Dev System** - ( Design Engineer ) | ||||||
| Create Proof of Concept WF task in Med Dev System** - ( Design Engineer ) | ||||||
| Perform Proof of Concept WF task in Med Dev System** - ( Design Contributor ) | ü* | ü* | ü* | |||
| Create & Perform Detailed Design WF task in Med Dev System** - ( Design Engineer ) | ||||||
| Create Risk Assessment** - ( Design Engineer ) | ||||||
| Perform Risk Assessment** - ( Design Contributor ) | ü* | ü* | ü* | |||
| Create Validation & Verification** - ( Design Engineer ) | ||||||
| Perform Validation & Verification** - ( Design Contributor ) | ü* | ü* | ü* | |||
| Create Environmental Analysis** - ( Design Engineer ) | ||||||
| Perform Environmental Analysis** - ( Design Contributor ) | ü* | ü* | ü* | |||
| Create & Manage BOM WF task in Med Dev System** - ( Design Engineer ) | ||||||
| Create & Manage DHF/DRM - ( Design Engineer ) | ||||||
| UDI | ||||||
| *The Med Dev Part (nunbe)) add-on server license for users to access functionality listed in this section with an asterisk next to the check mark. | ||||||
| View UDI | ü* | ü* | ü* | ü* | ||
| Create UDI | ü* | ü* | ü* | |||
| Submit UDI | ü* | ü* | ü* | |||
| Monitor UDI | ü* | ü* | ü* | |||
| Service | ||||||
| *At least one user in the system must have a Windchill Service Management (SAS-CPE7010-F-) or Windchill Parts Management (SAS-CPE7011-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||||||
| View Information & Publication Structures and the content within | ü* | ü* | ü* | ü* | ||
| Create/Manage Information Structures | ||||||
| Create/Manage Publication Structures | ||||||
| Set as Primary Information Structure | ||||||
| Generate Publication Structure | ||||||
| Generate Translation Document | ||||||
| Create, Manage and Assign Symptoms | ||||||
| Add Information & Publication Structure Associations (Impacted By) to Parts | ||||||
| Create and manage Translation Packages | ||||||
| Create and manage Delivery Content Reports | ||||||
| Textual and Graphic Information Element Requiring Update Report | ||||||
| Create/Assign/Edit Service Effectivity | ||||||
| Generate Parts List from BOM | ||||||
| Create and Update Parts List Illustration | ||||||
| Add Supplementary Replacement | ||||||
| Export Parts List to XML |
| On Prem Part Minimum Prerequisites | None | None |
| Registered User Part Number | SPN-CPE5630-F- | SPN-CPE5639-F- |
| Active Daily User Part Number | Not Available | Not Available |
| Kiosk Part Number | Not Available | Not Available |
| Designated Server Part Number | Not Available | Not Available |
| WC Part Name | Windchill Standard Author | Windchill Supplier Author |
| Find and view product information | ||
| Access to standard Navigate View Appss | ü | ü |
| Access to standard Navigate Contribute Apps | ü | ü |
| Access to standard Navigate Work Instruction Delivery App | ||
| Search Search indexed and non-indexed content Define and execute user-specific saved searches (but not global searches) |
ü | ü |
| View page content View any web page and web page content to which the viewer user is granted authorization |
ü | ü |
| View and Download non-CAD content Download and view any office document content Download any pre-published derived formats (PDF, IGES, STL) Request publishing of derived formats on demand (for those supported) Can not download any native CAD formats (MCAD, ECAD…) |
ü | ü |
| View reports created by others but cannot create or edit reports | ü | ü |
| View 2-D and 3-D models View thumbnails and 2-D and 3-D images images Pan, zoom, rotate Measure, section, explode View but do not create/edit annotations |
ü | ü |
| Subscribe to events Subscribe to be notified of events on items to which user has access |
ü | ü |
| Contribute & collaborate, Issue Identification | ||
| Participate in Projects | ü | ü |
| ü | ü | |
| Organize Create/edit folders Create/edit links |
ü | ü |
| Participate in assigned tasks Workflow tasks Project tasks Action item tasks |
ü | ü |
| Collaborate Create topics and discussion postings Create and save annotations Create/update action items Create/attach/edit office documents (including use of Desktop Integration) Generate PDFs of Office Docs and Mark them up Create and update meetings |
ü | ü |
| PDF Collaboration Generate PDFs of Office Docs and Mark them up |
ü | ü |
| Basic Authoring of content, and release and change management | ||
| Create/attach/edit office documents (including use of Desktop Integration) | ü | ü |
| Create, Participate, & Approve Promotion Requests | ü | ü |
| Approve Change Workflow tasks | ü | ü |
| Approve Design Reviews | ü | ü |
| Create/update problem reports | ü | ü |
| Create deviation or waiver | ü | ü |
| Revise documents | ü | ü |
| Create and manage collaboration projects (Does not include the ability to create and manage project plans, schedules resources) |
ü | ü |
| Create/Edit Project Route | ü | ü |
| Set State | ü | ü |
| Create Packages | ü | ü |
| Add To Packages | ü | ü |
| Create and manage Change Reguest, Change Notice, Change Task | ü | ü |
| Sequence Change Tasks | ü | ü |
| Revise Objects (Including Docs, CAD, Parts) | ü | ü |
| Create Design Review | ü | ü |
| Create and manage baselines | ü | ü |
| Manage templates and attributes (documents, parts, projects, teams, lifecycles, workflows) | ü | ü |
| Create and manage global searches and reports | ü | ü |
| Configure Actions for Roles | ü | ü |
| Basic Creation and Mangement of Arbortext Documents (Requires Arbortext Editor) | ü | ü |
| Basic Creation and Mangement of Creo Illustrate & ISODraw Illustrations (Requires Creo Illustrate or ISODraw respectiviely)) | ü | ü |
| Project Management | ||
| Create and manage projects, project teams and project content | ü | ü |
| Create and manage project templates, team templates and project workflow templates | ü | ü |
| Create, execute and manage project plans with milestones, activities and tasks | ü | ü |
| Create and manage project resources (people, equipment, facilities…) | ü | ü |
| Create and manage action items, discussion forums and notebooks | ü | ü |
| Create and manage project reports | ü | ü |
| Intellectual Property Protection | ||
| Have content filtered from view/access based on security label values. | ü | ü |
| Abiity to set security label value upon document creation | ü | ü |
| Ability to change seciroty label value on existing object | ü | ü |
| Create and manage security labels and classifications and control access to information based on user or group label or classification access level. | ü | ü |
| Create and manage agreements (such as NDA, ITAR) and control access to information based on the agreements that a user or group is covered to provide access to agreement-controled information. | ü | ü |
| Manage agreement creation and change through workflow process | ü | ü |
| Control which representations of content are available for view and download by groups/roles and users. For example, some users may be given access to native CAD formats and others will have only access to low-fidelity 2-D images or 3-D viewables. | ü | ü |
| Classification | ||
| View classification hiearchies and attributes and search for parts and documents using classifications and classification attribute ranges and values (parametric search). | ü | ü |
| Find Similar Parts Action | ü | ü |
| Create and update document classifications | ü | ü |
| Organize classifications into node hierarchies and manage hierarchies | ü | ü |
| Associate documents with classifications | ü | ü |
| Tailor specific business attributes unique to individual classification nodes | ü | ü |
| Define valid attribute characteristics and constraints | ü | ü |
| Layout and group attributes | ü | ü |
| Localize classification nodes and attributes for various languages | ü | ü |
| Associate one or more measurement system and units of measure with attributes | ü | ü |
| Import and export classification schema | ü | ü |
| Create and update part classifications | ü | |
| Associate parts with classifications | ü | |
| BOM Management | ||
| Create and manage product structures and engineering BOMs | ü | |
| Import BOM structure from Excel | ü | |
| Export Importable Spreadsheet | ü | |
| Create and manage product structure baselines | ü | |
| Create and manage product instances | ü | |
| Create and manage serialized products | ü | |
| "Basic" Options and Variants | ||
| Create and manage configurable parts and part structures | ü | |
| Add and update configurable parts to any part structure to support multiple configurations | ü | |
| Create and manage options, option pools and sets and choices and filtering | ü | |
| Define and manage rules, assigned item and usage expressions to control allowed options, choices, include, exclude and enable rules and valid configurations | ü | |
| Define parameters and values used to support structure-based optionality (in the Product Structure Explorer) | ü | |
| BOM Transformation | ||
| Transform an engineering BOM to a Manufacturing BOM | ||
| Define and manage plant specific data of Manufacturing BOM | ||
| Define and manage semi-finish Parts | ||
| Define and manage Standard Control Characteristics | ||
| Transform an engineering BOM to a Service BOM | ||
| Transform any BOM into another downstream BOM | ||
| Reconcile upstream changes to downstream BOM | ||
| Define and Maintain 3D Mocl Up of downstream BOM | ||
| MCAD Data Management | ||
| Download MCAD content | ü | |
| Automatically create and associate part BOM items with CAD documents on CAD document check in | ü | |
| Create and manage MCAD models using workgroup managers for Creo, CED, CEDD, MathCAD DM | ü | |
| Create and manage MCAD models using workgroup manager for CADDS 5 | ü | |
| Automatically publish CAD formats with included Creo View CAD adapters for all supported PTC CAD applications | ü | |
| Create and manage MCAD models using workgroup managers for Solidworks, Inventor and AutoCAD | ü | |
| Automatically publish CAD formats with included Creo View CAD adapters for Inventor and SolidWorks (native publishing is supported for AutoCAD) | ü | |
| Create and manage MCAD models using workgroup managers for NX and Catia | ü | |
| Automatically publish NX CAD formats with included Creo View CAD adapters for NX (An adapter for publishing Catia formats must be independently purchased from Theorem Solutions) | ü | |
| Manufacturing Process Management | ||
| Create and manage manufacturing resources | ||
| Create and manage process plans | ||
| Create and manage Work Instructions | ||
| Create and Manage Standard Capabilities | ||
| Author work instruction graphics with Creo View | ||
| Author work instruction graphics with Creo Illustrate | ||
| Platform Structure Management* | ||
| *At least one user in the system must have either Windchill Advanced Product Design (SPN-CPE5631-F-), or Windchill Manufacturing Process Planner (SPN-CPE5633-F-), or Windchill Service Parts (SPN-CPE5636-F-) add-on license for a customer to use any Platform Structures functionality listed in this section. | ||
| View Configurable parts and structure | ü* | ü* |
| Filter Configurable structure using Choices (Edit Filter) | ü* | ü* |
| Apply and existing Variant Specification to filter a structure | ü* | ü* |
| Configure a configurable part and create a variant | ||
| Define numeric choices | ||
| Define aliases for option choices | ||
| Manage and control process to govern changes to rules | ||
| Control what rules are applied using conditional logic (e.g., if <condition> then use Rule A/else us Rule B) and independent local rules | ||
| Define basic assigned occurrence expressions, advanced assigned item expressions, usage and occurrence expressions and independent assigned expressions. | ||
| Define and control via alternate option filtering | ||
| Define and manage nested products, merged option sets, product families, models and product variants | ||
| Import Variants and Variant specifications from a spreadsheet | ||
| Publish (export) platform structure information to ERP and other systems using ERP Connector | ||
| Programmatically load variants using variant loader APIs | ||
| From a generic part structure, create a configured or engineered to order structure based on a set of rules defined within the PLM system. | ||
| Supplier Component Management | ||
| *At least one user in the system must have either a Windchill Design Engineering (SAS-CPE7004-F-) OR Windchill Product Engineering (SAS-DPE7007-F-) OR Windchill Manufacturing (SAS-CPE7005-F-) OR Windchill Service Parts (SAS-CPE7011-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||
| View and search for supplier and supplier part information and attributes. | ü* | ü |
| Create a new Part Request | ü* | ü |
| Define one or more vendor parts that can be used for a company’s internal part | ü | |
| Define detailed functional characteristics for supplied parts and associate with specifications and other documents | ü | |
| Manage suppliers and supplied parts through supplier and supplier part introduction process workflows | ü | |
| Manage status of manufacturers and vendors (i.e., approved, pending, obsolete) | ü | |
| Identify default supplier and supplied part preferences based on part classification and context (Requires addition of Classification - SPN-CPE5464-F ) | ü | |
| Automatically update supplier preference list using configurable rules | ü | |
| Develop predefined reports on supplier metrics | ü | |
| Create rules for part grading based on supplier, sourcing context and commodity codes or classification | ü | |
| Automatically calculate a sourcing grade for an internal part, based on an analysis of its approved manufacturer list | ü | |
| Define one or more manufacturer parts that can be used for a company’s internal part | ü | |
| Import and export supplier part information with Microsoft Excel | ü | |
| Nonconformance | ||
| *At least one user in the system must have Windchill Quality Management (SAS-CPE7008-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||
| View Nonconformance, Investigation, and Disposition | ü* | ü* |
| New Nonconformance - ( Initiator ) | ü* | ü* |
| Nonconformance Management - ( manager ) | ||
| Nonconformance Review | ||
| Nonconformance Investigation - ( Investigator ) | ü* | ü* |
| Nonconformance Disposition and MRB - ( Evaluator / Manager ) | ||
| Nonconformance Perform Disposition - ( Dispositioner ) | ü* | ü* |
| Customer Experiences/Complaints | ||
| *At least one user in the system must have Windchill Quality Management (SAS-CPE7008-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||
| **The Medical Device Module add-on license is required for a customer to use any Complaints functionality listed in this section. | ||
| View Complaint, Investigation, and Action | ü* | ü* |
| View Regulatory Reports | ü** | ü** |
| New Customer Experience - ( Initiator ) | ü* | ü* |
| Customer Experience Management - ( Manager ) | ||
| Customer Experience Evaluation | ||
| Customer Experience General Activity | ü* | ü* |
| Customer Experience Product General Activity | ü* | ü* |
| Customer Experience Product Investigation Activity | ü* | ü* |
| Customer Experience Product Regulatory Activity | ||
| Customer Experience Review - ( Evaluator / Manager ) | ||
| CAPA | ||
| **At least one user in the system must have Windchill Quality Management (SAS-CPE7008-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||
| View CAPA, Confirmation, Investigation, CAPA Plan, and Action, | ü* | ü* |
| New CAPA Request - (Initiator ) | ü* | ü* |
| CAPA Management | ||
| CAPA Review - ( Evaluator / Manager ) | ||
| CAPA Investigation - ( Investigator ) | ü* | ü* |
| CAPA Plan - ( Evaluator / Manager ) | ||
| CAPA Perform Action - ( Evaluator / Manager ) | ü* | ü* |
| CAPA Effectiveness - ( Evaluator / Manager ) | ||
| Audit Management | ||
| *At least one user in the system must have a Windchill Audit Management (SAS-CPE7009-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||
| View Audit and Response | ü* | ü* |
| Create Schedule & Manage Internal and Exteral Audits - ( Audit Manager ) | ||
| Plan & Scope - ( Audit Manager ) | ||
| Conduct Audit - ( Audit Manager ) | ||
| Audit Response - ( Auditee - Responder ) | ü* | ü* |
| Manage Response - ( Audit Manager ) | ||
| Complete Audit - ( Audit Manager ) | ||
| Regulatory Hub | ||
| *At least one user in the system must have a Regulatory Hubl (SPN-CPE5569-F-) add-on license for a customer to use any Regulatory Hub functionality listed in this section. | ||
| View Regulatory Submissions | ü* | ü* |
| Create Submission - ( Regulatory Manager ) | ||
| Plan & Conduct Submission - ( Regulatory Manager ) | ||
| Add Content to Submission - ( Regulatory Contributor ) | ü* | ü* |
| Close Submission - ( Regulatory Manager ) | ||
| Document Control | ||
| *The Med Dev Part (nunber TBD)) add-on server license for users to access functionality listed in this section with an asterisk next to the check mark. | ||
| View Controlled Document | ü* | ü* |
| Create Controlled Document - ( Document Author ) | ü* | ü* |
| Revise Controlled Document - ( Document Author ) | ü* | ü* |
| Review Controled Document - ( Document Approver ) | ü* | ü* |
| Manage Qualified Roles - ( Document Manager ) | ü* | ü* |
| Manage Training - ( Document Manager ) | ü* | ü* |
| Complete Training - ( Document Trainee ) | ü* | ü* |
| Obsolete Controled Document - ( Document Manager ) | ü* | ü* |
| Design Control (** Future Release Enhancements) | ||
| *The Med Dev Part (nunber TBD)) add-on server license for users to access functionality listed in this section with an asterisk next to the check mark. | ||
| View Risk Assessment, Environmental Analysis, DHF/DMR, Requirement Artifact** | ü* | ü* |
| Create Requirement Artifact** - ( Product Manager ) | ü* | |
| Create High Level Design WF task in Med Dev System** - ( Design Engineer ) | ü* | |
| Create Proof of Concept WF task in Med Dev System** - ( Design Engineer ) | ü* | |
| Perform Proof of Concept WF task in Med Dev System** - ( Design Contributor ) | ü* | ü* |
| Create & Perform Detailed Design WF task in Med Dev System** - ( Design Engineer ) | ü* | |
| Create Risk Assessment** - ( Design Engineer ) | ü* | |
| Perform Risk Assessment** - ( Design Contributor ) | ü* | ü* |
| Create Validation & Verification** - ( Design Engineer ) | ü* | |
| Perform Validation & Verification** - ( Design Contributor ) | ü* | ü* |
| Create Environmental Analysis** - ( Design Engineer ) | ü* | |
| Perform Environmental Analysis** - ( Design Contributor ) | ü* | ü* |
| Create & Manage BOM WF task in Med Dev System** - ( Design Engineer ) | ü* | |
| Create & Manage DHF/DRM - ( Design Engineer ) | ü* | |
| UDI | ||
| *The Med Dev Part (nunbe)) add-on server license for users to access functionality listed in this section with an asterisk next to the check mark. | ||
| View UDI | ü* | ü* |
| Create UDI | ü* | ü* |
| Submit UDI | ü* | ü* |
| Monitor UDI | ü* | ü* |
| Service | ||
| *At least one user in the system must have a Windchill Service Management (SAS-CPE7010-F-) or Windchill Parts Management (SAS-CPE7011-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||
| View Information & Publication Structures and the content within | ü* | ü* |
| Create/Manage Information Structures | ||
| Create/Manage Publication Structures | ||
| Set as Primary Information Structure | ||
| Generate Publication Structure | ||
| Generate Translation Document | ||
| Create, Manage and Assign Symptoms | ||
| Add Information & Publication Structure Associations (Impacted By) to Parts | ||
| Create and manage Translation Packages | ||
| Create and manage Delivery Content Reports | ||
| Textual and Graphic Information Element Requiring Update Report | ||
| Create/Assign/Edit Service Effectivity | ||
| Generate Parts List from BOM | ||
| Create and Update Parts List Illustration | ||
| Add Supplementary Replacement | ||
| Export Parts List to XML |
| On Prem Part Minimum Prerequisites | Windchill Standard Author |
Windchill Standard Author |
Windchill Standard Author |
Design Engineering or Prodict Engineering |
| Registered User Part Number | SPN-CPE5638-F- | SPN-CPE5637-F- | SPN-CPE5634-F- | SPN-CPE5631-F- |
| Active Daily User Part Number | Not Available | Not Available | Not Available | Not Available |
| Kiosk Part Number | Not Available | Not Available | Not Available | Not Available |
| Designated Server Part Number | Not Available | Not Available | Not Available | Not Available |
| WC Part Name | Windchill Design Engineering Lite | Windchill Design Engineering | Windchill Product Engineering | Windchill Advanced Product Design |
| Find and view product information | ||||
| Access to standard Navigate View Appss | ||||
| Access to standard Navigate Contribute Apps | ||||
| Access to standard Navigate Work Instruction Delivery App | ||||
| Search Search indexed and non-indexed content Define and execute user-specific saved searches (but not global searches) |
||||
| View page content View any web page and web page content to which the viewer user is granted authorization |
||||
| View and Download non-CAD content Download and view any office document content Download any pre-published derived formats (PDF, IGES, STL) Request publishing of derived formats on demand (for those supported) Can not download any native CAD formats (MCAD, ECAD…) |
||||
| View reports created by others but cannot create or edit reports | ||||
| View 2-D and 3-D models View thumbnails and 2-D and 3-D images images Pan, zoom, rotate Measure, section, explode View but do not create/edit annotations |
||||
| Subscribe to events Subscribe to be notified of events on items to which user has access |
||||
| Contribute & collaborate, Issue Identification | ||||
| Participate in Projects | ||||
| Organize Create/edit folders Create/edit links |
||||
| Participate in assigned tasks Workflow tasks Project tasks Action item tasks |
||||
| Collaborate Create topics and discussion postings Create and save annotations Create/update action items Create/attach/edit office documents (including use of Desktop Integration) Generate PDFs of Office Docs and Mark them up Create and update meetings |
||||
| PDF Collaboration Generate PDFs of Office Docs and Mark them up |
||||
| Basic Authoring of content, and release and change management | ||||
| Create/attach/edit office documents (including use of Desktop Integration) | ||||
| Create, Participate, & Approve Promotion Requests | ||||
| Approve Change Workflow tasks | ||||
| Approve Design Reviews | ||||
| Create/update problem reports | ||||
| Create deviation or waiver | ||||
| Revise documents | ||||
| Create and manage collaboration projects (Does not include the ability to create and manage project plans, schedules resources) |
||||
| Create/Edit Project Route | ||||
| Set State | ||||
| Create Packages | ||||
| Add To Packages | ||||
| Create and manage Change Reguest, Change Notice, Change Task | ||||
| Sequence Change Tasks | ||||
| Revise Objects (Including Docs, CAD, Parts) | ||||
| Create Design Review | ||||
| Create and manage baselines | ||||
| Manage templates and attributes (documents, parts, projects, teams, lifecycles, workflows) | ||||
| Create and manage global searches and reports | ||||
| Configure Actions for Roles | ||||
| Basic Creation and Mangement of Arbortext Documents (Requires Arbortext Editor) | ||||
| Basic Creation and Mangement of Creo Illustrate & ISODraw Illustrations (Requires Creo Illustrate or ISODraw respectiviely)) | ||||
| Project Management | ||||
| Create and manage projects, project teams and project content | ||||
| Create and manage project templates, team templates and project workflow templates | ||||
| Create, execute and manage project plans with milestones, activities and tasks | ||||
| Create and manage project resources (people, equipment, facilities…) | ||||
| Create and manage action items, discussion forums and notebooks | ||||
| Create and manage project reports | ||||
| Intellectual Property Protection | ||||
| Have content filtered from view/access based on security label values. | ||||
| Abiity to set security label value upon document creation | ||||
| Ability to change seciroty label value on existing object | ||||
| Create and manage security labels and classifications and control access to information based on user or group label or classification access level. | ||||
| Create and manage agreements (such as NDA, ITAR) and control access to information based on the agreements that a user or group is covered to provide access to agreement-controled information. | ||||
| Manage agreement creation and change through workflow process | ||||
| Control which representations of content are available for view and download by groups/roles and users. For example, some users may be given access to native CAD formats and others will have only access to low-fidelity 2-D images or 3-D viewables. | ||||
| Classification | ||||
| View classification hiearchies and attributes and search for parts and documents using classifications and classification attribute ranges and values (parametric search). | ||||
| Find Similar Parts Action | ||||
| Create and update document classifications | ||||
| Organize classifications into node hierarchies and manage hierarchies | ||||
| Associate documents with classifications | ||||
| Tailor specific business attributes unique to individual classification nodes | ||||
| Define valid attribute characteristics and constraints | ||||
| Layout and group attributes | ||||
| Localize classification nodes and attributes for various languages | ||||
| Associate one or more measurement system and units of measure with attributes | ||||
| Import and export classification schema | ||||
| Create and update part classifications | ü | ü | ||
| Associate parts with classifications | ü | ü | ||
| BOM Management | ||||
| Create and manage product structures and engineering BOMs | ü | ü | ||
| Import BOM structure from Excel | ü | ü | ||
| Export Importable Spreadsheet | ü | ü | ||
| Create and manage product structure baselines | ü | ü | ||
| Create and manage product instances | ü | ü | ||
| Create and manage serialized products | ü | ü | ||
| "Basic" Options and Variants | ||||
| Create and manage configurable parts and part structures | ü | ü | ||
| Add and update configurable parts to any part structure to support multiple configurations | ü | ü | ||
| Create and manage options, option pools and sets and choices and filtering | ü | ü | ||
| Define and manage rules, assigned item and usage expressions to control allowed options, choices, include, exclude and enable rules and valid configurations | ü | ü | ||
| Define parameters and values used to support structure-based optionality (in the Product Structure Explorer) | ü | ü | ||
| BOM Transformation | ||||
| Transform an engineering BOM to a Manufacturing BOM | ü | |||
| Define and manage plant specific data of Manufacturing BOM | ü | |||
| Define and manage semi-finish Parts | ü | |||
| Define and manage Standard Control Characteristics | ü | |||
| Transform an engineering BOM to a Service BOM | ü | |||
| Transform any BOM into another downstream BOM | ü | |||
| Reconcile upstream changes to downstream BOM | ü | |||
| Define and Maintain 3D Mocl Up of downstream BOM | ü | |||
| MCAD Data Management | ||||
| Download MCAD content | ü | ü | ||
| Automatically create and associate part BOM items with CAD documents on CAD document check in | ü | ü | ||
| Create and manage MCAD models using workgroup managers for Creo, CED, CEDD, MathCAD DM | ü | ü | ||
| Create and manage MCAD models using workgroup manager for CADDS 5 | ü | ü | ||
| Automatically publish CAD formats with included Creo View CAD adapters for all supported PTC CAD applications | ü | ü | ||
| Create and manage MCAD models using workgroup managers for Solidworks, Inventor and AutoCAD | ü | ü | ||
| Automatically publish CAD formats with included Creo View CAD adapters for Inventor and SolidWorks (native publishing is supported for AutoCAD) | ü | ü | ||
| Create and manage MCAD models using workgroup managers for NX and Catia | ü | ü | ||
| Automatically publish NX CAD formats with included Creo View CAD adapters for NX (An adapter for publishing Catia formats must be independently purchased from Theorem Solutions) | ü | ü | ||
| Manufacturing Process Management | ||||
| Create and manage manufacturing resources | ||||
| Create and manage process plans | ||||
| Create and manage Work Instructions | ||||
| Create and Manage Standard Capabilities | ||||
| Author work instruction graphics with Creo View | ||||
| Author work instruction graphics with Creo Illustrate | ||||
| Platform Structure Management* | ||||
| *At least one user in the system must have either Windchill Advanced Product Design (SPN-CPE5631-F-), or Windchill Manufacturing Process Planner (SPN-CPE5633-F-), or Windchill Service Parts (SPN-CPE5636-F-) add-on license for a customer to use any Platform Structures functionality listed in this section. | ||||
| View Configurable parts and structure | ü | |||
| Filter Configurable structure using Choices (Edit Filter) | ü | |||
| Apply and existing Variant Specification to filter a structure | ü | |||
| Configure a configurable part and create a variant | ü | |||
| Define numeric choices | ü | |||
| Define aliases for option choices | ü | |||
| Manage and control process to govern changes to rules | ü | |||
| Control what rules are applied using conditional logic (e.g., if <condition> then use Rule A/else us Rule B) and independent local rules | ü | |||
| Define basic assigned occurrence expressions, advanced assigned item expressions, usage and occurrence expressions and independent assigned expressions. | ü | |||
| Define and control via alternate option filtering | ü | |||
| Define and manage nested products, merged option sets, product families, models and product variants | ü | |||
| Import Variants and Variant specifications from a spreadsheet | ü | |||
| Publish (export) platform structure information to ERP and other systems using ERP Connector | ü | |||
| Programmatically load variants using variant loader APIs | ü | |||
| From a generic part structure, create a configured or engineered to order structure based on a set of rules defined within the PLM system. | ü | |||
| Supplier Component Management | ||||
| *At least one user in the system must have either a Windchill Design Engineering (SAS-CPE7004-F-) OR Windchill Product Engineering (SAS-DPE7007-F-) OR Windchill Manufacturing (SAS-CPE7005-F-) OR Windchill Service Parts (SAS-CPE7011-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||||
| View and search for supplier and supplier part information and attributes. | ü | ü | ||
| Create a new Part Request | ü | ü | ||
| Define one or more vendor parts that can be used for a company’s internal part | ü | ü | ||
| Define detailed functional characteristics for supplied parts and associate with specifications and other documents | ü | ü | ||
| Manage suppliers and supplied parts through supplier and supplier part introduction process workflows | ü | ü | ||
| Manage status of manufacturers and vendors (i.e., approved, pending, obsolete) | ü | ü | ||
| Identify default supplier and supplied part preferences based on part classification and context (Requires addition of Classification - SPN-CPE5464-F ) | ü | ü | ||
| Automatically update supplier preference list using configurable rules | ü | ü | ||
| Develop predefined reports on supplier metrics | ü | ü | ||
| Create rules for part grading based on supplier, sourcing context and commodity codes or classification | ü | ü | ||
| Automatically calculate a sourcing grade for an internal part, based on an analysis of its approved manufacturer list | ü | ü | ||
| Define one or more manufacturer parts that can be used for a company’s internal part | ü | ü | ||
| Import and export supplier part information with Microsoft Excel | ü | ü | ||
| Nonconformance | ||||
| *At least one user in the system must have Windchill Quality Management (SAS-CPE7008-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||||
| View Nonconformance, Investigation, and Disposition | ||||
| New Nonconformance - ( Initiator ) | ||||
| Nonconformance Management - ( manager ) | ||||
| Nonconformance Review | ||||
| Nonconformance Investigation - ( Investigator ) | ||||
| Nonconformance Disposition and MRB - ( Evaluator / Manager ) | ||||
| Nonconformance Perform Disposition - ( Dispositioner ) | ||||
| Customer Experiences/Complaints | ||||
| *At least one user in the system must have Windchill Quality Management (SAS-CPE7008-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||||
| **The Medical Device Module add-on license is required for a customer to use any Complaints functionality listed in this section. | ||||
| View Complaint, Investigation, and Action | ||||
| View Regulatory Reports | ||||
| New Customer Experience - ( Initiator ) | ||||
| Customer Experience Management - ( Manager ) | ||||
| Customer Experience Evaluation | ||||
| Customer Experience General Activity | ||||
| Customer Experience Product General Activity | ||||
| Customer Experience Product Investigation Activity | ||||
| Customer Experience Product Regulatory Activity | ||||
| Customer Experience Review - ( Evaluator / Manager ) | ||||
| CAPA | ||||
| **At least one user in the system must have Windchill Quality Management (SAS-CPE7008-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||||
| View CAPA, Confirmation, Investigation, CAPA Plan, and Action, | ||||
| New CAPA Request - (Initiator ) | ||||
| CAPA Management | ||||
| CAPA Review - ( Evaluator / Manager ) | ||||
| CAPA Investigation - ( Investigator ) | ||||
| CAPA Plan - ( Evaluator / Manager ) | ||||
| CAPA Perform Action - ( Evaluator / Manager ) | ||||
| CAPA Effectiveness - ( Evaluator / Manager ) | ||||
| Audit Management | ||||
| *At least one user in the system must have a Windchill Audit Management (SAS-CPE7009-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||||
| View Audit and Response | ||||
| Create Schedule & Manage Internal and Exteral Audits - ( Audit Manager ) | ||||
| Plan & Scope - ( Audit Manager ) | ||||
| Conduct Audit - ( Audit Manager ) | ||||
| Audit Response - ( Auditee - Responder ) | ||||
| Manage Response - ( Audit Manager ) | ||||
| Complete Audit - ( Audit Manager ) | ||||
| Regulatory Hub | ||||
| *At least one user in the system must have a Regulatory Hubl (SPN-CPE5569-F-) add-on license for a customer to use any Regulatory Hub functionality listed in this section. | ||||
| View Regulatory Submissions | ||||
| Create Submission - ( Regulatory Manager ) | ||||
| Plan & Conduct Submission - ( Regulatory Manager ) | ||||
| Add Content to Submission - ( Regulatory Contributor ) | ||||
| Close Submission - ( Regulatory Manager ) | ||||
| Document Control | ||||
| *The Med Dev Part (nunber TBD)) add-on server license for users to access functionality listed in this section with an asterisk next to the check mark. | ||||
| View Controlled Document | ||||
| Create Controlled Document - ( Document Author ) | ||||
| Revise Controlled Document - ( Document Author ) | ||||
| Review Controled Document - ( Document Approver ) | ||||
| Manage Qualified Roles - ( Document Manager ) | ||||
| Manage Training - ( Document Manager ) | ||||
| Complete Training - ( Document Trainee ) | ||||
| Obsolete Controled Document - ( Document Manager ) | ||||
| Design Control (** Future Release Enhancements) | ||||
| *The Med Dev Part (nunber TBD)) add-on server license for users to access functionality listed in this section with an asterisk next to the check mark. | ||||
| View Risk Assessment, Environmental Analysis, DHF/DMR, Requirement Artifact** | ||||
| Create Requirement Artifact** - ( Product Manager ) | ü* | ü* | ü* | |
| Create High Level Design WF task in Med Dev System** - ( Design Engineer ) | ü* | ü* | ü* | |
| Create Proof of Concept WF task in Med Dev System** - ( Design Engineer ) | ü* | ü* | ü* | |
| Perform Proof of Concept WF task in Med Dev System** - ( Design Contributor ) | ||||
| Create & Perform Detailed Design WF task in Med Dev System** - ( Design Engineer ) | ü* | ü* | ü* | |
| Create Risk Assessment** - ( Design Engineer ) | ü* | ü* | ü* | |
| Perform Risk Assessment** - ( Design Contributor ) | ||||
| Create Validation & Verification** - ( Design Engineer ) | ü* | ü* | ü* | |
| Perform Validation & Verification** - ( Design Contributor ) | ||||
| Create Environmental Analysis** - ( Design Engineer ) | ü* | ü* | ü* | |
| Perform Environmental Analysis** - ( Design Contributor ) | ||||
| Create & Manage BOM WF task in Med Dev System** - ( Design Engineer ) | ü* | ü* | ü* | |
| Create & Manage DHF/DRM - ( Design Engineer ) | ü* | ü* | ü* | |
| UDI | ||||
| *The Med Dev Part (nunbe)) add-on server license for users to access functionality listed in this section with an asterisk next to the check mark. | ||||
| View UDI | ||||
| Create UDI | ||||
| Submit UDI | ||||
| Monitor UDI | ||||
| Service | ||||
| *At least one user in the system must have a Windchill Service Management (SAS-CPE7010-F-) or Windchill Parts Management (SAS-CPE7011-F-) add-on license for other users to access functionality listed in this section with an asterisk next to the check mark. | ||||
| View Information & Publication Structures and the content within | ||||
| Create/Manage Information Structures | ||||
| Create/Manage Publication Structures | ||||
| Set as Primary Information Structure | ||||
| Generate Publication Structure | ||||
| Generate Translation Document | ||||
| Create, Manage and Assign Symptoms | ||||
| Add Information & Publication Structure Associations (Impacted By) to Parts | ||||
| Create and manage Translation Packages | ||||
| Create and manage Delivery Content Reports | ||||
| Textual and Graphic Information Element Requiring Update Report | ||||
| Create/Assign/Edit Service Effectivity | ||||
| Generate Parts List from BOM | ||||
| Create and Update Parts List Illustration | ||||
| Add Supplementary Replacement | ||||
| Export Parts List to XML |
What makes SPK and Associates different?
Customer Relationships
Typically, our clients choose to collaborate with SPK and Associates for an extended period, often spanning over 8 years.
Regulated Industries
20+ years of experience with medical device, aerospace, automotive and other regulated industries
Hardware + Software
Uniquely positioned with years of understanding of both hardware and software product development
SPK
ACEs
SPK consistently ensures compliance, quality, and cost-efficiency when accelerating products to market
What Our Clients Say
SPK has been an invaluable partner in transforming our software development process. With SPK's guidance, our team embraced efficient methodologies and cutting-edge tools, significantly improving our development cycle and product quality.
Joshua Talbert
CEO, mysherpas
Working with SPK feels like working with co-workers in my company, not like interacting with a typical technical support vendor. SPK staff are responsive and partner with me.
Jay DiToro
Director of Systems & Technology, Veranex
The personalized attention and detailed communication we receive working with SPK and Associates is pretty special. The accessibility of SPK team members is impressive.
Evan Bruck
Director, Active Device Research and Development, BBraun Medical Inc.
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