Part 11, Electronic Records; Electronic Signatures - Scope and Application: Guidance for Industry | Guideline Explorer

Description

Office of Training and CommunicationsDivision of Drug InformationCenter for Drug Evaluation and Research (CDER)WO51, Room 220110903 New Hampshire AveSilver Spring, MD 20993Phone:301-796-3400Fax:301-847-8714E-mail:druginfo@fda.hhs.gov

Scope & Applicability

Stakeholders

1

Investigator

Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining

Regulatory Context

Attributes

1

Time Stamps

Recording time for systems spanning different time zones

Related CFR Sections (7)

21CFR11.10§ 11.10 Controls for closed systems.
Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate theRead full regulation →
21CFR11.30§ 11.30 Controls for open systems.
Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt.Read full regulation →
21CFR11.2§ 11.2 Implementation.
(a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met.Read full regulation →
21CFR58.130§ 58.130 Conduct of a nonclinical laboratory study.
(a) The nonclinical laboratory study shall be conducted in accordance with the protocol.Read full regulation →
21CFR211.180§ 211.180 General requirements.
(a) Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lRead full regulation →
21CFR108.25§ 108.25 Acidified foods.
(a) Inadequate or improper manufacture, processing, or packing of acidified foods may result in the distribution in interstate commerce of processed foods that may be injurious to health. The harmful nature of such foods cannot be adequately determined after these foods have entered into interstate Read full regulation →
21CFR108.35§ 108.35 Thermal processing of low-acid foods packaged in hermetically sealed containers.
(a) Inadequate or improper manufacture, processing, or packing of thermally processed low-acid foods in hermetically sealed containers may result in the distribution in interstate commerce of processed foods that may be injurious to health. The harmful nature of such foods cannot be adequately deterRead full regulation →

Related Warning Letters (10)

CGMP/Finished Pharmaceuticals/Adulterated
SV Labs Corporation
2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Guangdong Renhe Guozhuang Biotechnology Co., Ltd.
2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
Medinatura New Mexico, Inc.
2025-12-23
CGMP/Finished Pharmaceuticals/Adulterated
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2025-12-16
CGMP/Deviations/Biologics License Application (BLA)
Microvascular Tissue, Inc.
2025-12-16
CGMP/Finished Pharmaceuticals/Adulterated
Catalent Indiana, LLC
2025-12-11
CGMP/Finished Pharmaceuticals/Adulterated
DeVere Manufacturing Inc.
2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
CDL Services, Inc. DBA Technichem
2025-12-09
CGMP/Finished Pharmaceuticals/Adulterated
Seaway Pharma Inc.
2025-12-09
CGMP/QSR/Medical Devices/Adulterated
Envoy Medical Inc.
2025-12-09