74309d7132 It is important that these evaluations are carefully performed by the system owner and agreed upon by the company Quality Unit. Validation should ensure accuracy, reliability, consistent intended performance and the ability to discern invalid and altered records. You should allow inspection, review, and copying of records in a human readable form at your site using your hardware and following your established procedures and techniques for accessing records. Audit Trail The Agency intends to exercise enforcement discretion regarding specific part 11 requirements related to computer-generated, time-stamped audit trails ( 11.10 (e), (k)(2) and any corresponding requirement in 11.30). We suggest that you apply appropriate controls based on such an assessment. However, records must still be maintained or submitted in accordance with the underlying predicate rules, and the Agency can take regulatory action for noncompliance with such predicate rules. While the Agency is deliberating, it is recommended that each company judiciously reviews its needs and implements reasonable procedures. Records that are required to be maintained under predicate rules, that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities. Broad sections of the regulation have been challenged as "very expensive and for some applications almost impractical", and the FDA has stated in guidance that it will exercise enforcement discretion on many parts of the rule. The performance qualification assures that the user requirements have been met and the system does what it is supposed to do as specified in the user requirements.
We had decided we wanted to minimize industry time spent reviewing and commenting on the draft guidance when that draft guidance may no longer represent our approach under the CGMP initiative. For example, if a record is required to be maintained under a predicate rule and you use a computer to generate a paper printout of the electronic records, but you nonetheless rely on the electronic record to perform regulated activities, the Agency may consider you to be using the electronic record instead of the paper record. About Us Management Team Employment Our Services Drug & Device Combination Products Formulation & Drug Delivery Technologies Biopharmaceutical Formulation Contract and Grant Partnering Preformulation Micro & Nano Technology cGMP Clinical Manufacturing Analytic Bioanalytic Physical Characterization ICH Stability Drug Release Testing Toxicology & Pharmacokinetic Services News & Publications Articles Press Releases Technical Briefs Contact Us Code of Federal Regulations Title 21 Part 11 Requirements Particle Sciences - Technical Brief: 2012: Volume 1 PDF Version Background As part of the Food and Drug Administration (FDA) Modernization Act, in 2003, the Agency drafted a guidance document (Guidance for Industry Part 11, Electronic Records; Electronic Signatures — Scope and Application1). Table of Contents II. In the Federal Register of February 4, 2003 (68 FR 5645), we announced the withdrawal of the draft guidance for industry, 21 CFR Part 11; Electronic Records; Electronic Signatures, Electronic Copies of Electronic Records. Table of Contents. The current technical architecture of computer systems increasingly makes the Part 11, Electronic Records; Electronic Signatures Scope and Application for the complete and accurate copy requirement extremely high. . 3894 Courtney Street, Suite 180 Bethlehem, PA 18017 610-861-4701 www.particlesciences.com News & Publications Articles Press Releases Technical Briefs Why Us? Particle Sciences transforms your discovery into a clinic-ready product. Complaints about the wasting of critical resources, non-value added aspects, in addition to confusion within the drug, medical device, biotech/biologic and other industries about the true scope and enforcement aspects of Part 11 resulted in the FDA release of:.