21CFR Part 11 compliance and Adept Scientific software
Large and growing enterprises are facing a new challenge. That challenge is the complexity of complying with government regulations designed to protect public health and safety.
The most notable of these is Section 21 Part 11 of the Code of Federal Regulations, which establishes the standards by which the Food and Drug Administration will accept electronic records and electronic signatures as equivalent to paper records and handwritten signatures. The rule governs electronic records throughout their lifecycle from creation through modification, storage, and final transmission to the FDA.
Although 21CFR Part 11 has been in the draft stage for almost a decade, final regulations have now been created. Enforcement of these regulations is beginning to take place and enterprises are responding with a wide variety of initiatives, both within individual organisations and across industry sectors.
Two important components of compliance are the positive identification of the person creating or modifying data records, and the use of audit trails for the data and system parameters affecting its collection and management. This implies the use of software and computer systems that provide adequate security, protection, and audit trails for collecting and managing data.
Some of the technical software solutions supplied by Adept Scientific can help your organisation work towards becoming 21CFR11 compliant. You’ll find statements below concerning the software for which this new regulation has most impact.
Section 21 Part 11 of the Code of Federal Regulations establishes the standards by which the Food and Drug Administration will accept electronic records and electronic signatures as equivalent to paper records and handwritten signatures. The rule governs electronic records throughout their lifecycle from creation through modification, storage, and final transmission to the FDA.
The creation of this regulation and the FDA’s encouragement of the use of electronic records and signatures have placed a significant burden on the developers and users of data collection, management, reporting, and analysis software in regulated industries.
Two important components of compliance are the positive identification of the person creating or modifying data records, and the use of audit trails for the data and system parameters affecting its collection and management. This implies the use of software and computer systems that provide adequate security, protection and audit trails for collecting and managing data.
Compliance and validation are critical to the decision making process for purchasing and updating software. As NWA is a major supplier of data analysis software to the pharmaceutical industry and their suppliers, they acknowledge their responsibility to provide software that contributes to meeting these requirements.
Since NWA software is most commonly used as part of larger integrated information systems, much effort has been focused on how the software interacts with compliant data management systems and how it contributes to establishing and preserving the integrity of the overall system.
The leader in desktop spectroscopy software, GRAMS/AI includes tools to help your laboratory more easily achieve a state of operation that is compliant with 21CFR11. It provides features that are designed to help your lab implement procedures and function within a 21CFR11 compliant environment. Proper use of GRAMS/AI provides comprehensive audit logging, system security and data security. Even if your company isn’t yet directly affected by 21CFR11, the features in GRAMS/AI are ideal for compliance with Good Laboratory Practices (GLP).
CambridgeSoft applications, such as E-Notebook Enterprise and Document Manager, are at the leading edge of the integration of corporate knowledge management with 21CFR11 Compliance. These products are designed so that as your organization reviews its internal processes for 21CFR11 Compliance, the software can be configured to support these internal processes. Major requirements of 21CFR11, such as electronic signatures, audit trails, and long-term archiving, are incorporated within the routine workflow to generate the critical information required by research, development and production. In addition, E-Notebook Enterprise and Document Manager can be integrated with existing critical data systems.
For further information about 21CFR Part 11, you might find these links useful:
www.fda.gov – official FDA website
www.21cfrpart11.com – privately run site containing information and links
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