Implementation of a low-cost Interim 21CFR11 compliance solution for laboratory environments
2003
Low-Cost Solution for 21CFR11 Compliance in Laboratories
publication
Evidence: moderate
Author Information
Author(s): Jack E. Greene
Primary Institution: Alkermes, Inc.
Hypothesis
Can a low-cost interim solution effectively address compliance with 21CFR11 in laboratory environments?
Conclusion
The proposed solution offers an acceptable level of compliance with 21CFR11 at a significantly lower cost than commercial options.
Supporting Evidence
- The solution implements computer system security and an automated audit trail.
- It allows for backup and restore of electronic records.
- The approach is cost-effective compared to commercial solutions.
Takeaway
This study suggests a cheaper way for labs to follow important rules about keeping electronic records safe and secure.
Methodology
The study discusses the implementation of a low-cost interim solution that includes computer system security, backup and restore capabilities, and an automated audit trail.
Limitations
The solution does not address all issues raised by 21CFR11 and may have challenges with version control.
Digital Object Identifier (DOI)
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