Regulatory and Quality Compliance in the Pharmaceutical Industry through the AVEVA PI System
In the pharmaceutical and biotechnology industry, the adoption of paperless systems has been essential since the 1980s, driven by compelling economic reasons. These Systems are used to automate, monitor and report on operations. production, and play a fundamental role in Good Manufacturing Practices (GMP). As such, they are subject to FDA regulations.
In the 1990s, the technologies available for processing and authenticating electronic records reached a point where the industry needed specific guidelines for FDA acceptance of paperless systems. In March 1997, the FDA responded with the regulation known as 21 CFR Part 11.
21 CFR Part 11 focuses on the authenticity, integrity and confidentiality of records electronic and electronic signatures. Computer systems must be validated to ensure the accuracy, reliability and consistency of operations, as well as their ability to identify invalid or altered records. A key requirement for compliance is the system's ability to create an audit log or management database audit. This database must provide a secure record of all attempts to access or login to the system, along with the operations performed.
The audit management database must meet the following criteria:
- Audit logs are secure, computer-generated, and time-stamped.
- The person making any changes must be identified.
- Both original data and modified data must be recorded.
- Evidence of previously modified or deleted data should be visible.
- Must be accessed for review purposes.
21 CFR Part 11 is highly significant because it allows electronic records to be considered equivalent to paper records, and electronic signatures to be considered equivalent to handwritten signatures. The regulation undergoes gradual implementation, with an initial focus on drug manufacturing. It is expected that paper records will no longer be accepted in the near future. Existing computer systems must be updated or replaced to comply with Good Manufacturing Practices (GMP) by ensuring that production processes repeatedly conform to batch recipes and that products meet rigorous quality specifications.
VEVA's PI System supports GMP by monitoring the entire production process, from recipe downloading to automated batch report generation, and also applies login security and audit logs for any manual data changes. PI System is ready for validation with supporting documentation that meets all FDA requirements.
PI System has been installed for many years in the management of electronic records in the pharmaceutical and biotechnology industries. Capabilities that have contributed to the successful implementation of PI include long-term archiving, automatic backup, integration of all process data in the plant, batch tracking and reporting, and statistical quality control.
PI System addresses compliance with 21 CFR Part 11 as follows:
- Logs all value modifications, system configuration, and user security changes.
- Provides tools to generate selected reports and facilitate FDA audit requests.
- Enforces authorized access and password management.
- Detects any attempts to modify records in the audit management database.
The provisions of the regulation make computer system validation a prerequisite for compliance with 21 CFR Part 11. Therefore, the availability of software functions to comply with access security and the management of electronic records and signatures Electronic communications, although necessary, do not in and of themselves constitute compliance. Compliance depends on the successful validation of the specific computer systems used in drug manufacturing and their ongoing support.
Application in regulated industries requires a rigorous, common-sense approach to meeting validation and verification requirements. Many industries are subject to environmental, health and safety regulations, especially in pharmaceuticals and biotechnology, where plant information and process control systems are used to make decisions that affect product quality, safety and suitability. for your use. Both the underlying process control system and the associated Plant Information System (PI) must undergo rigorous and documented validation and verification.
Compliance with 21 CFR Part 11 begins with computer system validation. PI has specific features and capabilities that support compliance, and Levex offers customer assistance and support to simplify the PI software validation process and verify system specifications and functionality.
¿Querés contactar con un especialista?