The FDA recommends a risk-based approach to validating software used directly or in support of medical device manufacturing or quality systems. Life Sciences CROs have similar processes for proving their processes and tools are in a validated state. Using a document-based approach reliant on Word or Excel for FDA CSA (computer software assurance) is inefficient and error-prone.

A smarter, more efficient solution is Jama Connect® for Medical Devices and Life Sciences.

Read this datasheet to learn more about key benefits:

• Get the most out of your requirements management solution
• Save time through risk-based approach to validation
• Accelerate preparation of documentation
• Enable easy collaboration by internal teams and contractors
• Simplify the validation of Jama Connect