Validation Kit for Medical Device & Life Sciences

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