EU Annex 11


How Annex 11 Computerized Systems Can Help with Compliance

The European Union (EU) recently revised Annex 11 of its "Volume 4: Good Manufacturing Practice" for human and veterinary medicines to address problems stemming from an increasingly computerized GMP environment, in which computer programming can potentially replace human judgment. Annex 11 provides guidance to help ensure electronic record integrity, which in turn helps ensure product safety.

While Annex 11 is not a regulation, it is key to compliance with GMP principles in EU directives (regulations) covering human and veterinary medicinal products. Ignoring EU Annex 11 could be as detrimental as ignoring the directives.

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How MasterControl's Annex 11 Computerized Systems Comply with EU Annex 11

The revised EU Annex 11 covers a broad area that includes electronic signatures and archiving, emphasizes risk management, and expounds more on validation and security. MasterControl was designed to comply with the most rigorous regulations and standards, including EU Annex 11. Here is how it can help life science companies with their compliance efforts in the European Market:

  • EU Annex 11's first principle broadens the scope of the guidance. It states: "This annex applies to all computerised systems used as part of GMP-regulated activities." MasterControl is an electronic, centralized, web-based platform for all processes critical to regulated companies, such as document management, audit management, forms-based processes, quality management, change management, corrective and preventive action, training control, product lifecycle management, bill of materials, and submissions management.

  • EU Annex 11's second principle emphasizes validation. It states: "The application should be validated; IT infrastructure should be qualified." MasterControl provides an array of validation solutions and services based on industry best practices. MasterControl experts can provide thorough assistance, from validation training for staff to protocol development and all the way to IQ, OQ, and PQ execution. MasterControl's Transfer Operational Qualification (TOQ) was designed for companies looking to reduce the pain and cost of validation by "transferring" OQ documentation as part of the overall validation effort.

  • EU Annex 11's Section 2, Personnel: There should be close cooperation between all relevant personnel. All personnel should have appropriate qualifications, level of access, and defined responsibilities to carry out their assigned duties. MasterControl provides a single, centralized platform for all relevant personnel, making cooperation easy. It connects all critical processes so collaboration among different teams is seamless. MasterControl's training management solution will help ensure that all relevant personnel are properly trained for their responsibilities and re-trained accordingly.

  • EU Annex 11's Section 9, Audit Trails: For change or deletion of GMP-relevant data, the reason should be documented. Audit trails need to be available and convertible to a generally intelligible form. MasterControl provides a time-stamped audit trail that captures any changes, documents the reasons for the changes, as well as the user's identity.

  • EU Annex 11's Section 12, Security: Physical and/or logical controls should be in place to restrict access to unauthorized persons. Suitable methods of preventing unauthorized entry to the system should be provided. MasterControl's security features include dual passwords for document approval; password expiration, encryption, and certification; account lockout to stop unauthorized users.

  • EU Annex 11's Section 14, Electronic Signatures: Electronic signatures are expected to be permanently linked to their respective records, and include the time and date they were applied. MasterControl can automatically append an electronic signature manifestation (name, date, time, and meaning of e-signature) to every document approved. The system automatically links an e-signature to its respective record.

  • EU Annex 11's Section 17, Archiving: Archived data should be checked for accessibility, readability, and integrity. If relevant changes are made to the system, then the ability to retrieve the data should be ensured and tested. With MasterControl, documents can be managed with the appropriate retention policy based on regulatory requirements and a company's internal policies. MasterControl's InfoCard, a tool that summarizes information about a document and serves as a placeholder in the database, makes it easy to set a document's expiration date. Expired records can be archived for compliance purposes.

Additional Benefits from MasterControl's Annex 11 Computerized Systems

Obtaining marketing authorization for a new medicine or medical device is a costly and arduous process, but doubly so in Europe, where there are multiple regulatory bodies. Pharmaceutical and medical device companies are likely to have simultaneous marketing authorization applications (MAA) with various agencies.

MasterControl can help companies accelerate compliance by streamlining and connecting all processes critical to their MAA documentation. Apart from complying with EU Annex 11, MasterControl offers these additional benefits:

  • Automated Routing, Escalation, and Approval: All compliance documents can be routed, reviewed, and approved electronically, greatly increasing efficiency. Tasks will be transparent and easier to track. Tasks that are not completed within a certain period will be escalated automatically.

  • Centralized, Web-based System: All MAA and compliance documents will reside in one place, making search and retrieval easy. MasterControl is web-based, so all users will be able to access the system anytime from virtually anywhere.

  • Connected Processes: Compliance requires close coordination of different departments within a company, such as regulatory affairs, quality, and manufacturing. Many companies also work closely with outside parties (CROs, consultants, suppliers). By using MasterControl as a platform, all of these processes and stakeholders can come together more easily and effectively.

  • Inspection Readiness: With MasterControl, users will always be ready for inspections because the system streamlines all processes and provides inspectors with transparency and easy access to critical information.

For More Information on EU Annex 11 Computerized Software Systems

For more information on MasterControl and how it can help with EU Annex 11 computerized software systems, please contact a MasterControl representative.