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GxP Environments: Document Control in the Context of Change Control

Document Control in GxP Regulated Industries

Document Control - 17 November 2015

It is well-known that in GxP regulated industries, document control is a linchpin of quality and compliance. For several years now, I’ve seen an evolution in document control practices. Before getting into that, however, I’d like to first reinforce a few key concepts and principles:

1. All documents required by a Quality System should be controlled. This principle applies to all documents mandated by GxP regulations.

2. GxP regulations require that the facility, equipment, processes, specifications, and procedures used in the manufacture, packaging, labeling, quality control, testing, holding, and distribution of products be documented.

3. The term ‘controlled document’ means that there is a formal process for the authoring, review, approval, publishing, issuance, revision/change, retrieval, and archiving of documents. It assures that:

Documents are reviewed and approved by quality and other appropriate subject-matter experts (SMEs) prior to being made effective

Only the current version of the document is official and available for use

Unauthorized and uncontrolled copies are not in distribution

Previous/obsolete versions are not in circulation

Archiving of documents is appropriately structured

Over the years, I have seen electronic document control generally accomplished in three ways. I would like to emphasize that none of these are intrinsically better or worse than the other—it simply depends on the level of control, involvement, and oversight that companies want.

Broadly, the three ways are:

1. Use of a Basic Document Management Application

Provides document processing with 21 CFR Part 11 compliance, and

Links to training

2. Use of a Document Control Process

Provides pre-approval as an option on the change before documents are circulated for review and approval

Establishes the role of a Document Coordinator

Establishes more controls for grouping documents and follow-up on training and setting documents effective

3. Use of a Comprehensive Change Control System

Provides a comprehensive process for the review, approval, and implementation of changes

In order to appropriately decide which option is best for your organization, I recommend you create a simple matrix which indicates how each type of document should be managed. Keep in mind that the best solution might be the use of several options depending on the change and type of document. You don’t need to restrict yourself to one system to manage all change types. That is because not all changes and documents require the same level of control.

For example:

Type of Change/ Document Type
Comprehensive Change Control
Document Control Process
Document Management Application
Changes to documents and information provided in CMC section of a dossier for Equipment, Facility, Process

Changes to documents and information NOT detailed in CMC section of a dossier for Equipment, Facility, Process


Quality Manual

Master Batch Record/Device Master Record

Test Methods (CMC)

Specifications (CMC)


SOPs (Annual Review)

Annual Product Review

Quality Agreements

Validation Protocols

Validation Report

Building a complete table (like the one presented above) and including it as part of your organization’s overall Change Management Procedure will clarify what process to use when requesting changes.

I had planned to cover periodic reviews today as well… but let’s leave that subject for an upcoming blog in this series!

About the Author
As CEO of SOLABS, and almost 17 years after co-founding the company, Philippe Gaudreau continues to grow an avid interest in quality management and compliance practices in the Life Sciences. He is passionate about finding best in class solutions, with the goal of helping our Life Sciences clients automate their quality operations without losing the flexibility they have with their manual systems. He offers his expertise through his devotion to software development, his deep knowledge of business process management and optimization, and his expertise in document life cycle management.

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