All About Document Control Management DCM

What is Document Control Management DCM

 

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.

For more information about who needs document control management DCM, press here.

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:

  1. SOP Standard Operating Procedures,
  2. Work Instructions,
  3. Batch Records,
  4. Training Records,
  5. Validation and Qualification documents,
  6. CAPA investigations,
  7. Change Control
  8. Calibrations certificates,
  9. Preventive maintenance work
  10. Testing certificates or reporting results
  11. Forms
  12. Policy and others.

All controlled documents must be approved by the authorized and qualified representatives of the company.

For more information about each type of document to controlled, press here.

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.

  1. Manual Document and Handwritten Approval. This is the traditional and most common type of document and approval since it consists of a hardcopy paper with manual signatures of the document(s). A registry, list, and index of all manual or hand documents approved must be documented, maintained, and saved appropriately for future reference.  In the same manner, the signatures and initials of each approver must be registered and saved appropriately.

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.

  1. Electronic Document and Approval. This approval is more modern and consists of an electronic signature using a computer device and application to control the authentication of each signature.   According to the 21 CFR part 11, an electronic record means “any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system.” The same code of federal regulations defines the electronic signature as “a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.”

For more information about all different kinds of documents and approvals

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:

  1. Draft Document – unapproved,
  2. Original Document Approved,
  3. Copy or Duplicated Document,
  4. Obsolete Document, etc.

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:

 

Document Controls Document Status
Draft Document

(Unapproved)

Original Document (Approved) Copy or Duplicated Document (Approved) Obsoleted Document
Must contain a unique number? No Yes Yes Yes
Must be approved by a qualified representative(s)? No Yes Yes Yes
Copies must have a unique number (serial number on duplicated documents)? No n/a Yes No
Storage Control? No Yes Yes Yes
Version control, history, and audit trail of any change? No Yes Yes n/a

For more information about all Types of Document Status, press here.

7 Good practices in Document Control Management.

  1. Reviewing and approving documents prior to release.
  2. Ensuring changes and revisions are clearly identified with the history of change and the audit trail.
  3. Ensuring that relevant versions of applicable documents are available at their “points of use”
  4. Ensuring that documents remain legible and identifiable.
  5. Ensuring that external documents (such as customer-supplied documents or supplier manuals) are identified and controlled.
  6. Preventing “unintended” use of obsolete documents.
  7. Bring and document the training associate with the document.

For more information about good practices in document control management, press here.

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.

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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:

  1. Specification criteria for raw materials, internally/externally manufactured components, or internally/externally finished products
  2. Packaging or labeling information, processes, or materials.
  3. The shelf life of raw material, components, or finished products
  4. Process parameters
  5. Tools or consumables (i.e. wipes, gloves, shoe covers, etc.)
  6. Equipment or equipment settings
  7. Qualified cleanrooms
  8. Cleaning processes of the manufacturing environment or manufacturing equipment
  9. Facilities or utilities
  10. Locations for manufacturing, testing, sterilization, or warehousing
  11. Environmental conditions of manufacturing, testing, or storage,
  12. Control of monitoring processes for the manufacturing, testing, storage, or distribution environment
  13. Suppliers or external manufacturers
  14. Line re-configuration as it relates to operators changing from a seated to standing position, updates to the line and station layouts, or re-sequencing of process steps
  15. Throughput time as it relates to changes to the material storage time between processes
  16. Product handling techniques as it relates to material storage and conveyance
  17. Working with multiple lots at different stations
  18. Layouts in areas of product handling like manufacturing and warehouse
  19. Any change that can potentially impact form, fit or function, and the quality of the product.
  20. Changes related to supplied items, raw material, components, or finished products in regards to:
    1. manufacturing or assembly processes
    2. control or monitoring processes
    3. cleaning processes
    4. product handling
    5. inspection or release processes
    6. configuration check inspections
    7. sample size or sampling plans
    8. method of testing (e.g. physical, analytical, microbiological)
    9. packaging or labeling processes
    10. sterilization process
    11. storage, shipment, or distribution processes.

For more information about When is necessary a Document Control Management, press here.

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.

For more information about why initiate a document control form, press here.

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))

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

https://www.fda.gov/media/75414/download

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)

  1. Document Control number:
  2. Version
  3. Reason and description of the change:
  4. Permanent change,
  5. What changes in the document?
  6. Why the document change/justification?
  7. How changes the document?
  8. Where changes the document?
  9. When changes the document?
  10. Document change type categorization (decision tree
  11. Impacted areas of the document change
  12. Document change requirements
  13. Document change implementation
  14. Request, implementation completion & closure approval

More information about How to Fill a Document Control Form

brought to you by CIQA logo

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 ramon.cayuela@ciqa.net.

A Document Control Management DCM procedure template is available from the CIQA Store.

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Quality procedures templates

Three (3) Options to Create Document Control Management DCM Procedures:

Bronze Option. You Can Create Your Own Quality Procedures, using a Template.

You can download samples of the Document Control Management DCM procedure templates in .pdf format. 

To see the complete list of the most popular quality procedures templates, click here.

In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.

Silver Option. We Can Bring You a Formal Training on how to prepare and implement Document Control Management DCM.

This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools.  It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant.  Request a quote now.

Gold Option. We Can Create Customized Quality Procedures.

One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.

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REFERENCES:

For more information about Document Control Management, refer to:

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application

https://www.fda.gov/media/118202/download

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.40

QS Regulation and Guidance • Quality System Regulation and Preamble

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1

www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/QualitySystemsRegulations/ucm230127.htm

Inspection Guide – Pages 8, 15, 21, 22 and 23

https://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074899.htm

Guide to Inspections of Quality Systems [Quality System Inspection Technique (QSIT)]

www.fda.gov/iceci/inspections/inspectionguides/ucm074883.htm

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!

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