Medical device and life sciences companies may need to validate their use of Jama Connect® (depending on their intended use(s) of the system) regardless of whether it is predicated on regulatory guidelines, such as:
• ISO 13485: 2016
• 21 CFR 820.70 Production and Process Controls
• FDA Draft Guidances: General Principles of Software Validation (2002) and Computer Software Assurances (2022)
• Internal organization quality and governance processes
The Validation Kit for Jama Connect® is designed to reduce the time and resources required for validation by providing a complete list of Jama Software®’s internal mechanisms, workflows, usage scenarios, and test cases that are used in the process of internal validation activities in obtaining our TÜV SÜD Validation Certificate. Use this Validation Kit to:
- Streamline your process and shorten the time it takes to validate Jama Connect
- Define safety-critical workflows for clear starting points
- Validate in cloud and self-hosted environments
