21 CFR Part 11 Calibration Records
Regulated life sciences teams often need calibration documentation that is organized, reviewable and aligned with electronic-record controls. TOTAL Calibration Solutions supports the calibration records side of these programs by helping teams maintain clear asset information, due dates and traceable certificate documentation.
What calibration records should include
- Asset ID, manufacturer, model, serial number, range and location.
- Calibration interval, due date, service status and required documentation level.
- Certificate records that support traceability and audit review.
- Clear routing by calibration discipline for mixed equipment lists.
Useful connected services
For broader program support, see calibration record management services, calibration certificate services, calibration recall management, pharmaceutical calibration, biotech calibration and GxP calibration services.
Frequently asked questions
Does TotalCal provide validation software?
No. TotalCal supports calibration services and documentation. Your organization owns validation of electronic systems and Part 11 controls.
Can TotalCal help organize calibration records for an audit?
TotalCal can help with calibration certificate documentation, asset-list details, due dates and routing equipment to the correct calibration discipline.
Which teams need calibration record control?
Quality, validation, metrology, laboratory operations, manufacturing and facilities teams commonly need controlled calibration records.