Automation isn’t just for manufacturing tasks. In fact, many of the grinding, repetitive tasks your engineers can’t stand can easily be automated out of existence. Any task that is repeatable is automatable. That means you can save big money on man hours, letting your...
PDM/PLM-Product Data and Lifecycle Management
The 12 Principles Behind the Agile Manifesto: Principle Number Six – Promote Face To Face Interaction
Welcome back to our series as we continue to examine the 12 principles underlaying the Agile Manifesto! Our topic for this installment is principle six's guidance on effective communication. This principle states the following: The most efficient and effective method...
The 12 Principles Behind the Agile Manifesto: Principle Number Seven – The Primary Progress Indicator
This installment of our 12-part series on the principles of the Agile Manifesto deals with principle 7. This principle states: Working software is the primary measure of progress" In a traditional waterfall development cycle, all the design is done up front and the...
How To Leverage Jira as a Service Desk
Many of you are undoubtedly familiar with using Jira as an issue tracker. But for those of you who have been juggling issue tracking and meeting SLA requirements -- and for those of you who had the recently acquired VertygoSLA addon -- this article may be useful...
One-click Installer for PADS Flow 9.3 and Update1
Everyone loves a one-click installer, but setting this up can be a headache, especially when a company changes the way this is done. You can setup your installation script to install both PADS9.3 and PADS9.3_update1 with a double-click of the mouse! Here are the first...
How to Install Software Packages Using Ninite
This week we want to have a look at a useful website that enables us to quickly and accurately install any of a large number of useful software packages. The website, www.ninite.com, presents a large number of current freeware packages, along with trial versions of a...
Sample PTC Integrity Reporting
Download the Requirements Traceability Report This report starts with a Market Requirements document, and traces down to the Tests and Test Results. Sheet 1 covers compact categorization, where the artifacts are basically defined by the Document types. Sheet 2...
CAPA: A Review of 21 C.F.R. §820.100 and FDA Warning Letter Trends
SPK and Associates routinely review warning letters to help our clients stay in step with FDA trends. One of the problem areas most often cited in company audits continue to be the CAPA system/program. This month we will take a look at some of the latest FDA...
Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
Design Output: A Review of 21 C.F.R. §820.30(d) and FDA Warning Letter Trends
Static Analysis: Improving Quality by Finding Coding Issues As Soon As Possible
Many companies utilize static analysis tools in some fashion. However, we often find they are not leveraging them to their fullest potential. At SPK and Associates, we believe in driving quality up front, at the Engineering Desktop, and not relying solely on finding...
5 Things You Can Do To Make Your Software More Attractive To Medical Device Companies
Improve Your Ability to Sell Software into Medical Device Companies – In this paper we will share five things you can do to make your software application more attractive to medical device companies.
Continuous Builds – A Customer Experience
Software Development Lifecycle (SDLC): In our last article we discussed speeding up your build by leveraging tools such as Electric Accelerator. In this article we will discuss the process of Continuous Integration (CI) along with a customer experience utilizing...