Achieve 21 CFR Part 11 compliance
Upgrade to digital data logging and storage
FDA 21 CFR Part 11 Compliance
Regulatory agencies are now willing to accept paperless records but many producers in the food & beverage, pharmaceutical and biotech industries haven’t yet converted or even planned to transition to paperless solutions.
Robust record keeping is at the heart of FDA 21 CFR Part 11 compliance and while the regulation itself does not require users to maintain records electronically, the processing of data electronically has many advantages:
- The utilization of the data by other systems: e.g. data viz applications, ERP systems, spreadsheets.
- The retrieval and comparison of several recording periods (not just the last 12 hrs) to observe trends that might otherwise be overlooked between physical charts.
- Elimination of paper handling and the need to manage, store, or maintain large numbers of paper records.
- Clear and informative audit trails.
- Data backups and redundancy fail-safes.