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, we have a 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 of our efforts has been focused on how our software interacts with compliant data management systems and how we contribute to establishing and preserving the integrity of the overall system. NWA has prepared a road map for NWA software and 21CFR Part 11 compliance. To request a copy, click here.  | www.fda.gov | | | This is the official FDA web site, and includes all of the official 21CFR11 documents, including supporting material such as Guidance documents, enforcement actions, hearing notes and notices, and records of meetings related to the regulation. | | www.21CFRPart11.com | | | This is a privately run site that provides a wide range of information, documents, industry contributions, and links to other sites. |
Many NWA partners supply information management systems to regulated industries and have years of experience in understanding and meeting these requirements. These systems include both laboratory and process management software.
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