My continuing adventure with 21 CFR Part 11--the evolution of Zymark's compliance
2001
Zymark's Journey to Compliance with 21 CFR Part 11
publication
Evidence: moderate
Author Information
Author(s): Stephen M. Dobro
Primary Institution: Zymark Corporation
Hypothesis
How can Zymark ensure its laboratory automation equipment complies with 21 CFR Part 11?
Conclusion
Zymark successfully validated its products for compliance with 21 CFR Part 11, improving both product quality and customer satisfaction.
Supporting Evidence
- Zymark developed a standard validation plan to evaluate both existing and new products.
- The validation process included expert and customer reviews to ensure thoroughness.
- Testing revealed non-compliance issues that were addressed with software updates.
- The PreludeTM product was designed to be compliant from the start, demonstrating the effectiveness of the validation plan.
Takeaway
Zymark worked hard to make sure its lab equipment followed important rules about electronic records and signatures, which helps customers meet their needs.
Methodology
The study involved a chronological review of the validation process for Zymark's products to ensure compliance with 21 CFR Part 11.
Digital Object Identifier (DOI)
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