If data integrity is not maintained, the credibility of scientific findings is at risk. In regulated environments, labs face the added responsibility of complying with regulations like FDA 21 CFR Part 11 and EU GMP Annex 11.
To ensure data integrity, lab managers must implement strategies that uphold data accuracy, security, and reliability throughout its lifecycle. This involves careful consideration of questions like: Is there an approved SOP for data review? Are data interfaces secure against tampering and breaches? Can you ensure that your legacy data remains accessible and intact?
The following data integrity checklist offers a structured approach for evaluating and improving your lab's data integrity practices. It guides you through key checkpoints, from sensor calibration and data transfer security to implementing access controls and audit trails, helping build a comprehensive framework for safeguarding data.
Download the data integrity checklist to explore:
- Requirements essential for maintaining GxP quality guidelines and standards
- Best practices for sensor installation, calibration verification, and data review
- Strategies for preventing data tampering and loss
- How to safeguard data with audit trails and access control measures
