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.
Comprehensive Change Control
Document Control Process
Document Management Application
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!
CEO & SME, SOLABS