Life science organizations are among the most tightly-regulated entities on the planet.

Highly-specific regulations such as FDA’s Code of Federal Regulations, Title 21, Part 11 and the EU’s Eudralex Volume 4, Annex 11 demand strict adherence to Computer System Validation (CSV) best practices to confirm compliance.

To ensure that our products can be used to assist in the digitization of your GxP regulated process, InnovX Solutions conducted an independent assessment of the Panaya Test Dynamix Platform.

Read the full report to learn:

  • How Panaya empowers life sciences organizations to enjoy the benefits of electronic processes, while maintaining compliance with Title 21, Part 11 regulations.
  • How your organization can define a validation strategy for using the Panaya Test Dynamix as part of a GxP regulated process.
Common Mistakes in ERP Validation

Author: Frederic Landry

Read about 5 common and risky mistakes tied to validating ERP systems, and how they could be avoided.

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What is CFR part 11

Author: William Bellavance

Read about CFR 21 part 11 legislation, the reasons that led to the need for this regulation, and why following it is crucial to maintain compliance and is beneficial to organizations.

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