Importance of Document Control on a Quality Management System

by | Nov 5, 2021 | Analytics, Compliance, Consulting Group, Data, FDA, Guidance, ISO, QMS, Quality, Quality Systems, Regulatory, Requirements, Standardization, Standards


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In highly regulated industries, document control is among the most necessary means for compliance. A document control system strengthens the management of files and allows for compliance with regulatory and quality systems (QS) within FDA, ISO, EU, and more. It is the foundation of any quality, compliance, or regulatory process.

Quality management systems are a vital component of compliance and quality culture in any regulated industry. While quality management is multi-faceted, document control must comply with cGMP and other regulatory requirements for standard operating procedures, organizational policies, and other essential quality processes.

Document control allows for certainty in the most up-to-date information and readily accessible revisions or outdated copies. It is essential to maintain control of copies and have records as proof of compliance with specifications that portray the effectiveness of the QS1.  The document management system should ensure that only the right people have access to mitigate the risk of information leakage. Accidental data exposure may result in non-compliance, a competitive advantage loss, a HIPPA violation, damage to brand reputation, or other threats.

Procedures for document control should specify, based on specific criteria, who can create, revise, review and approve documents. The quality assurance policies necessitate the need for a review of the documents to ensure accuracy. 21 CFR 11 outlines the requirements for implementing an electronic document management system, including the regulatory requirements for electronic signatures and passwords2.

Beyond a regulatory requirement, all industries and companies can benefit from a standardized solution for managing documents. The more robust and useable a document management system is, the safer and higher quality a product may be, ultimately improving patients’ lives. If you need help designing or implementing a document control system, EMMA International can help. Contact us at 248-987-4497 or email info@emmainternational.com for more information.

References: 

[1] Seland, D. (2021, May 6). The Ins and outs of document control. Quality Magazine RSS. Retrieved November 2, 2021, from https://www.qualitymag.com/articles/96492-the-ins-and-outs-of-document-control

[2] FDA – PART 11    ELECTRONIC RECORDS; ELECTRONIC SIGNATURES retrieved on 11/02/2021 from https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11&showFR=1&subpartNode=21:1.0.1.1.8.3

Alexis Ferrier

Alexis Ferrier

Alexis is a Technical Writer at EMMA International. She has research and development experience in both device and drug products. Additionally, Alexis has experience in quality assurance, quality control, regulatory requirements, and international compliance. She holds a Bachelor of Science in Chemistry from Michigan Technological University.

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