In Pharma, every data point matters
In the pharmaceutical industry, the accuracy of an analytical result is essential, but it is not enough. Good Manufacturing Practices (GMP) require documented and controlled processes: data must remain reliable, complete and traceable throughout their lifecycle. In this context, Data Integrity principles are fundamental to Quality Control and Quality Assurance activities.
For electronic systems subject to US regulations, FDA 21 CFR Part 11 establishes requirements applicable to electronic records and electronic signatures. In Europe, EU GMP Annex 11 provides a regulatory reference for computerized systems used in GMP activities.
To address these needs, Steroglass introduces aWData 21CFR, the new software designed for the aWLife water activity meter, developed to support the applicable requirements of 21 CFR Part 11 in controlled environments.
From measurement accuracy to data traceability
Water activity (aW) measurement is a valuable parameter for the characterization and quality control of pharmaceutical formulations, including tablets, powders and lyophilized products. With aWData 21CFR, the analytical performance of aWLife is complemented by dedicated features for controlled data management.
- Automatic Audit Trail: Chronological recording of critical operations, including user identification, date and time. Audit trail records cannot be modified or deleted through the software.
- Electronic Signatures: Authentication through individual user credentials and recording of the reason for critical operations.
- Controlled Access: Individual user accounts, differentiated access roles, account lockout after failed login attempts and automatic logout after periods of inactivity.
- Record Integrity: Protected local database, integrity checks and prevention of record modification or deletion through the user interface.
- Documentation and Data Protection: Reports exportable in PDF, CSV and Excel formats, with administrative backup and restore functions.
A solution for laboratories operating under GMP
aWData 21CFR extends the capabilities of aWLife, combining analytical accuracy with tools for more secure, documented and traceable data management.
Because in a pharmaceutical laboratory, accurate measurement alone is not enough: it is essential to be able to reconstruct and demonstrate the reliability and integrity of every result.
aWLife + aWData 21CFR | Accurate measurements. Traceable data.
Discover the new software: contact the Steroglass team for more information.
Regulatory Note: aWData 21CFR is designed to support the applicable requirements of 21 CFR Part 11. System validation within the operating environment, GMP procedures, IT security and data retention remain the responsibility of the user organization. Reference to EU GMP Annex 11 is provided for regulatory context only and does not constitute a declaration of software compliance with this annex.