In this article, you will learn about Document Control Management DCM.
What is Document Control Management DCM?
The document control management (DCM) is intended to enforce disciplined processes and practices for the creation, review, modification, issuance, distribution, and accessibility of documents.
Who needs document control management?
All cGMP regulated industries including food & drugs manufacturers, medical-device manufacturing (FDA), manufacture of blood, human cells, and tissue products (FDA), healthcare (JCAHO), information technology (ITIL), third party manufacturers, and its suppliers of critical components or materials need to comply document control management.
What 12 types of documents must be controlled?
Document management controls are intended for cGMP documents stored either manual or electronic, to provide evidence that the QMS documentation and its related forms are under control —such as:
All controlled documents must be approved by the authorized and qualified representatives of the company.
What two 2 kind of documents and approvals exists?
Typically, exist two types of documents and approvals, in either case, the approvers must have the necessary standing, education, and experience to be designated for such purpose.
According to the 21 CFR part 11, a handwritten signature means “the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form.” The act of signing with a writing or marking instruments such as a pen or stylus is preserved.” The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.
5 Types of Document Status
Each company defines and establish their own document states that the document control management must handle for each document or piece of evidence. Examples of the most common document status are:
What 4 types of controls must have the documents based on their status?
Based on the status of each GMP document, different controls may apply to them.
1 Draft Document
2. Original Document
3. Copy Document
4. Obsoleted Document
These controls include version control, unique numbering control, and copy control of forms and documents based on their status.
The following table show how some companies define the controls for each document based on their status:
7 Good practices in Document Control Management.
What is an audit trail or document history?
The audit trail is a requirement of the 21 CFR part 11 related to the history of the computer-generated, time-stamped document (§ 11.10 (e), (k)(2), and §11.30). Persons must still comply with all requirements related to documentation of, for example, date (e.g., § 58.130(e)), time, or sequencing of events, as well as any requirements for ensuring that changes to records do not obscure previous entries.
Audit trails can be particularly for the document history and appropriate when users are expected to create, modify, or delete regulated records during normal operation.
The audit trail and document history can be handled either manually or electronically depending on how your company has established document control management.
When is necessary a Document Control Management?
Documentation control management needs it whenever a change is introduced to the established GMP procedures, batch record instructions, specifications, equipment settings, validated process, material, product, etc.
More specifically, a GMP document must be controlled if it adds, modifies, or impact any of the following areas:
Why initiate a Document Control effort?
Government regulations require that companies working in pharmaceutical industries control their documents.
Some industries work under stricter document control requirements due to the type of information they retain for privacy, warranty, or other highly regulated purposes.
Failing to comply can cause fines, loss of business, or damage to a business’s reputation.
Moreover, the GMP and the QSR mandate to establish a change control management system.
In addition, document control serves as a historic log book and tracking system of all changes in the chronologic order that a document suffers. It helps to evaluate, investigate, correlate, and document how and where are the document modifications by date and by the reviewer. It may support the document revision and updating schedules during its life cycle.
Consequences to not initiate or not perform an adequate Document Control on-time?
Failure to adhere to proper Document Control handling is considered a violation of US Federal regulations on good manufacturing practices. As a consequence, medicine or medical device can be termed as adulterated or substandard if the company has failed to implement, record, and analyze the outcome of a change, and failed to design and implement an effective document control. In some cases, it may result in an FDA warning observation, product hold, product recall, etc.
STATUTORY AND REGULATORY REQUIREMENTS
Title 21 CFR Part 11 that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES), as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a))
How to Fill a Document Control Form in 14 Steps?
The Document Control may include, but, is not limited to complete the following sections and information, (as applicable)
More information about How to Fill a Document Control Form
CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at firstname.lastname@example.org.
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For more information about Document Control Management, refer to:
QS Regulation and Guidance • Quality System Regulation and Preamble
Inspection Guide – Pages 8, 15, 21, 22 and 23
Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]