With the increasing use of computers to support analytical processes and manage experimental data, standardized regulations were set to address security concerns and data protection issues.
In this regard, most companies operating in the pharmaceutical, cosmetics, and food & beverage industries are required to comply with regulations such as the FDA’s Code of Federal Regulations Title 21 Part 11.
The responsibility for compliance rests with the user, but dedicated software upgrades and documentation provided by the instrument manufacturer help achieve 21 CFR Part 11 compliance and make the difference in the lab.
FDA’s 21 CFR Part 11 and its application in analytical labs
The FDA’s Code of Federal Regulations Title 21 Part 11 defines the requirements for using electronic records and electronic signatures on computerized systems. The integrity, reliability, and trustworthiness of electronic records must be fulfilled as for 21 CFR Part 11 basic requirements.
The whole workflow in the laboratory is subject to 21 CFR Part 11 regulations, thus full compliance can only be achieved by analyzing activities and defining in detail how sample-handling steps, experimental methods, and use of instruments should be performed.
The chain of data custody, the risk of system failure, and control measures are fundamental aspects when designing 21 CFR Part 11 compliant laboratory workflows.
Compliance is therefore not limited to installing software or instruments that support 21 CFR Part 11 compliance, but they are at the core of it.
How to achieve compliance to 21 CFR Part 11
CFR (Code of Federal Regulations) Chapter 21 part 11 defines the basic criteria for which electronic records (data) and electronic signatures are considered reliable, trustworthy, and equivalent to paper documents with handwritten signatures.
Furthermore, it establishes requirements related to electronic signatures, electronic records, and controls on electronic record systems.
When designing a compliant workflow in the lab the following provisions must be met:
- Track and record any settings or changes to settings
- Track who performs any operation
- Ensure the quality and incorruptibility of recorded data
- Set up user profiles in terms of control to ensure the right delegation of responsibilities at the right level (user management)
Discover VELP software upgrade solution that help you meet 21 CFR Part 11 provisions
VELP 21 CFR Part 11 Package helps you achieve full compliance with Subpart B – Electronic Records and Subpart C – Electronic Signatures of the regulation:
- Track and record of settings and any changes to settings with the system log function running permanently, serving as an audit trail
- Track who performs any operation as analysis results are automatically signed with the user information. Each user has a unique identification and electronic signature
- Ensure the quality and incorruptibility of recorded data with backup procedures. Exported files are protected from unwanted or improper alteration
- Ensure the right delegation of responsibilities at the right level with the user management system with three access levels.