In March of 1997, FDA issued final part 11 regulations that provide criteria for acceptance by FDA, under certain circumstances, of electronic records, electronic signatures, and handwritten signatures executed to electronic records as equivalent to paper records and handwritten signatures executed on paper. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. Note that part 11 remains in effect and that this exercise of enforcement discretion applies only as identified in this guidance.įDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. In addition, we intend to exercise enforcement discretion and do not intend to take (or recommend) action to enforce any part 11 requirements with regard to systems that were operational before August 20, 1997, the effective date of part 11 (commonly known as legacy systems) under the circumstances described in section III.C.3 of this guidance. 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. That is, we do not intend to take enforcement action to enforce compliance with the validation, audit trail, record retention, and record copying requirements of part 11 as explained in this guidance. While the re-examination of part 11 is under way, we intend to exercise enforcement discretion with respect to certain part 11 requirements. This guidance explains that we will narrowly interpret the scope of part 11. We anticipate initiating rulemaking to change part 11 as a result of that re-examination. The underlying requirements set forth in the Act, PHS Act, and FDA regulations (other than part 11) are referred to in this guidance document as predicate rules.Īs an outgrowth of its current good manufacturing practice (CGMP) initiative for human and animal drugs and biologics, 4 FDA is re-examining part 11 as it applies to all FDA regulated products. Part 11 also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations (§ 11.1). Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. This document provides guidance to persons who, in fulfillment of a requirement in a statute or another part of FDA's regulations to maintain records or submit information to FDA 3, have chosen to maintain the records or submit designated information electronically and, as a result, have become subject to part 11.
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This guidance is intended to describe the Food and Drug Administration's (FDA's) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations Electronic Records Electronic Signatures (21 CFR Part 11). If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. Guidance for Industry 1 Part 11, Electronic Records Electronic Signatures. Approach to Specific Part 11 Requirements.
Overall Approach to Part 11 Requirements.Manufacturers Assistance Phone Number: 80 or 30Ĭenter for Food Safety and Applied Nutrition (CFSAN) Phone: the Voice Information System at 80 or 30ĭivision of Small Manufacturers, International, and Consumer Assistance (HFZ-220) Center for Biologics Evaluation and ResearchĬenter for Drug Evaluation and Research (CDER)Ĭenter for Biologics Evaluation and Research (CBER)
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