FDA 21 CFR Part 11 Compliance Checklist: A Practical Guide

FDA 21 CFR Part 11 Compliance Checklist: A Practical Guide

Regulation 21 CFR Part 11 FDA lays down the requirements according to which the electronic records and electronic signatures should be regarded as credible, dependable, and identical to the paper records and handwritten signatures. Part 11 compliance is mandatory in those life sciences organizations that employ electronic systems in the GMP, GLP, and GCP controlled settings. A planned compliance checklist assists organizations in evaluating preparedness, gaps and sustain compliance.

Scope of 21 CFR Part 11

Part 21 CFR 11 covers electronic records, which are developed, revised, stored, archived, recovered, or transmitted pursuant to the FDA regulation. These are systems like Laboratory Information Management Systems (LIMS), Manufacturing Executive Systems (MES), Quality Management Systems (eQMS) and systems that are used to manage electronic documents.

Key Elements of a 21 CFR Part 11 Compliance Checklist

• The computer systems should be verified to be accurate, reliable, perform at a consistent rate, and detect any invalid or altered records.
• Validation documentation must consist of user requirements, risk assessment, testing protocol, and reports.

• This grants individuals or users the right to access the computer or its software.
• Access to the system should be only to verified officers.
• It must have unique user IDs, secure passwords, and even role-based access control.
• There should be procedures regarding the creation, modification, as the deactivation of accounts.

• Electronic records should be captured in secure, computer-generated audit trails, which documents the creation, modification, or deletion of electronic records.
• Audit trails must be time stamped and must not be subject to change.

• The electronic signatures should be individual and not reused or reallocated.
• Components that are considered signature should be user identification, date and time and meaning of signature.

• The protection of electronic records should be done to maintain accuracy, completeness, and readability of records within the time of retention.
• The procedures of backup, archiving, and retrieving data must be well defined and tested.

How Masuu Global Supports 21 CFR Part 11 Compliance

Masuu Global offers end-to-end compliance solutions based on 21 CFR Part 11 regulations, such as system evaluation, validation services, evaluation of the audit trail, evaluation of electronic signatures, development of checklists to ensure compliance, development of SOPs, and development of compliance strategies. The company assists with vendor evaluations, risk-based validation approaches, and preparation for inspections by the FDA.

A properly designed checklist for complying with 21 CFR Part 11 regulations is an important part of being in line with regulations in an electronic environment. Organizations can ensure that data integrity and inspection readiness are guaranteed by applying Masuu Global knowledge of FDA regulations related to digital compliance.