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White Papers

Below you will find researched reports or guides on topics chosen by the experts at SPK and Associates.  Our team looks for complicated problems that we’ve solved in order to share with others.  Our goal is to share our knowledge in order to create better products, faster and better than ever before.

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A Compliance Guide to Ensuring Software Validation in FDA-Regulated Medical Devices

A Compliance Guide to Ensuring Software Validation in FDA-Regulated Medical Devices

Unlock the secrets to seamless FDA compliance with our comprehensive eBook. This practical guide breaks down the regulations and standards that matter most, including 21 CFR Part 11 and Part 820, and walks you step-by-step through risk-based validation, robust...

Ensuring Information Quality and Version Control with the Top 10 ISO 9001 Practices

Ensuring Information Quality and Version Control with the Top 10 ISO 9001 Practices

Achieving compliance with ISO 9001 requires making quality and version control a priority. This eBook explores our experts’ ten best practices for ensuring ISO 9001 compliance.What You Will Learn Discover tips for achieving ISO 9001 certification such as: Establish a...