How to Avoid FDA Warning Letters
Lack of data integrity is the main reason cited from warning letters issued by the US Food and Drug Administration (FDA) sent to companies. Most often, the issue is incomplete data, which is preventable with the right solutions.
For laboratories seeking compliance with GLP, GMP, and GAMP regulations, it is important to have records or documented evidence of all relevant analyses that are easily accessible for audits. Designing and implementing a complete data governance strategy will help laboratories keep track of results and comply with audits.
The updated Laboratory Data Integrity Guide aims to help readers understand the current regulatory environment and improve analytical procedures to ensure regulatory compliance and data integrity. Download the guide to get access to expert knowledge on:
- How to address 21 CFR 11 and EU Annex 11 regulations for computerized systems
- Practical tips on how to implement compliant and efficient processes to capture electronic records
- Recommendations of laboratory software solutions to streamline your processes
An Enhanced Strategy for Data Integrity
Data governance includes four components: data integrity, traceability, security, and quality.
- Data Integrity: data is complete, consistent, and accurate
- Data Traceability: data is tracked throughout its lifecycle
- Data Security: data is secure from loss, alteration, or theft
- Data Quality: data is derived from appropriately calibrated instruments
Data integrity is one component of a comprehensive data-management strategy to help organizations meet all regulations and compliance standards more easily.
Data Management with One Software
To ensure careful, accurate, and complete data records that are archived and managed compliantly, the most effective solution is a ready-made, configurable software package that drives workflow SOPs directly through instruments. METTLER TOLEDO’s LabX™ and STARe offer automatic, integrated instrument management and data capture functionalities that improve the efficiency of the lab and the audit process.
