Lab Balance Provides 21 CFR Part 11, EU Annex 11 Compliance
Sartorius’ Cubis® II is the first to support all requirements to achieve lab balance compliance (21 CFR part 11 and EU Annex 11) without needing additional software, eliminating the usage of paper which bears the risk of falsifying process data and/or signatures.
21 CFR Part 11 and EU Annex 11 Compliance
Why Is 21 CFR Part 11 and EU Annex 11 Compliance Important?
- As manufacturers move toward digitizing operations, these two regulatory items offer Good Manufacturing Practice (GMP) protocols and outline conditions for electronic data management. These regulations have paved the way for more EU and FDA inspections, meaning manufacturers must maintain vigilance to avoid falling into non-compliance. Organizations found to be in non-compliance (i.e., record protection, systems validation) can potentially receive warning letters, market recalls or distribution bans. These actions can prove costly for organizations and can damage professional reputations.
- The existence of Annex 11 and Part 11 encourages life science companies to exert high-level vigilance for their electronic data. They provide a clear roadmap of regulatory expectations, making it easier for digitized companies to always maintain compliance.
How Do I Know My Balance Is CFR Part 11 Compliant?
There are a variety of factors to determine if a laboratory balance is fully compliant. Ideally, a balance should operate on a closed system with access controlled by those responsible for electronic record content. Additionally, compliant systems utilize usernames and passwords. Consult the lab balance compliance checklist to make sure your system is where it needs to be.
Six Features That Make Cubis® II Lab Balance 21 CFR Part 11, EU Annex 11 Compliant
All data generated by the Cubis® II balance follow the key principles ALCOA (+), which defines data integrity standards and relates to GxPs. Therefore, the Cubis® II balance ensures safe and accurate data storage and supports all requirements for FDA directive 21 CFR part 11 and EU Annex 11 compliance.
The Cubis® II balance, with pharma package, contains all the technical controls to support compliance with common regulations. Full compliance can be achieved with additional procedural controls and systems for long-term data storage.
- Audit Trail & Alibi Memory
The Cubis® II balance’s audit trail is a tamper-protected, time-stamped electronic logfile that allows reconstruction of events related to the creation, modification and/or deletion of records. The data can easily be displayed, filtered and exported. Additionally, the Cubis® II balance contains an “Alibi Memory” to store raw weighing data. Automatically generated audit trail and Alibi Memory entries are stored in a ring buffer.
Cubis® II can automatically execute timer-controlled actions for backup, audit trail and Alibi memory export. The system can upload MD5 checksum protected data on a file share or export to other systems. Therefore, archiving with Cubis® II is easy and fully compliant.
- User Management
The Cubis® II balance provides two options for complete user management with access control. Local user management can be configured in accordance with your password policy (password rules for 21 CFR Part 11 compliance are easily implemented). Moreover, Cubis® II can be integrated into a company´s domain (LDAP) to allow single sign-on. In this case, company-defined password rules are implemented automatically.
- Safe Data Transfer
Electronic records should be well-protected against manipulation. The Cubis® II balance saves all exported files together with a calculated MD5 checksum which is also written into the audit trail. By comparison of the exported checksum with the audit trail entry the integrity of the exported files can be checked.
- Electronic Signatures
In the Cubis® II balance, an electronic signature can be used to sign the final report for weighing processes. Based on a secure password, the combination of username and password is fully compliant with 21CFR.
- Time Synchronization
The Cubis® II balance supports automatic time synchronization via Network Time Protocol (NTP). An accurate time stamp is elemental for accurate records.
Pharma Compliance at Your Fingertips
The Cubis® II with pharma package contains all the technical controls to support compliance with the FDA directive 21 CFR Part 11 and EU Annex 11. Full compliance can be achieved with additional procedural controls and systems for long-term data storage (Figure 2).
Frequently Asked Questions
To maintain compliance with Title 21 of the U.S. Food and Drug Administration’s Code of Federal Regulations, companies must submit verification documents that confirm the validity of electronic records as well as the authenticity of electronic signatures. Companies must also confirm the validity of the software systems processing their digital data.
21 CFR Pharma refers to a federally mandated set of rules and guidelines for the regulation of electronic signatures and data in medical and pharmaceutical devices.
When electronic information gleaned from laboratory equipment is deemed compliant with the regulations set by the FDA, it is deemed trustworthy and can therefore be relied upon by customer organizations. This is extremely important, particularly from a GxP standpoint.
At a glance, EU Annex 11 is to the European Union what 21 CFR Part 11 is to the FDA. While similar, there are differences in guidelines and regulatory practices. For example, EU Annex 11 includes hardware, software, personal and risk management in addition to the regulation of electronic signatures and data.