Despite being around since 1997, the FDA’s guidance around Electronic Records and Electronic Signatures (21 CFR Part 11) is still giving many quality managers quite a headache. A lack of clarity around the characteristics and features a software solution must have to comply with 21 CFR Part 11 is one challenge sponsors face, the other is addressing the perceived risk and cost of implementing such a solution - especially in a cloud environment.

In this 45 minute webinar, you will learn:

  • The features a QMS software must offer to support your organization in achieving 21 CFR Part 11 compliance
  • How cloud-based QMS software can reduce costs and rapidly accelerate your time to implement
  • How AODocs can be leveraged to help you become, and remain, compliant with 21 CFR Part 11
  • How Continuous Validation powered by xLM can remove the burden of Computer Software Validation requirements and enable the move to the cloud


45 min


Speakers

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