Data integrity guidelines have had recent significant effects on pharma microbial QC labs. The costs and delay to implement compliant processes are substantial. For some, failure to comply with the requirements has put a hold on product release or on-site qualification.
This APR whitepaper uncovers data integrity requirements and what auditors may be looking for in your lab, including:
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- Basic principles (ALCOA)
- Risk mitigation for the microbiology QC lab
- Manually recorded data verification (i.e. 4 eyes)
- Electronic solutions, including automated methods