How to Fill a Document Control Request Form in 14 Steps?

How to Fill a Document Control Request Form in 14 Steps

 

In this article, you will learn how to fill a Document Control Request Form (DCR) in 14 steps during the Document Control Management (DCM) lifecycle.

According to ISO 9001:2008 standard in section 4.2.3 on document control states, “All documents required by the quality management system shall be controlled.”

This means that if a document addresses or relates to any of the issues in ISO 9001: it must be controlled.

The Document Control Request Form may include, but, is not limited to complete the following 14 steps 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.

The following table shows an example of a Document Control Request Form.

document change control form example

Document Control Request Form Example

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

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.

TO PURCHASE A TEMPLATES PROCEDURE, click here.

CONTACT US IF NEED HELP TO MAKE OR REVIEW YOUR DOCUMENT CONTROL REQUEST FORM?

Need training, help, or support to create a Document Control Request Form? 

SUBSCRIBE AND FOLLOW US TO LEARN MORE.

For more details on specific FDA expectations, follow us.

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 a Document Control Request Form.

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.

GET IN COMPLIANCE TODAY, CONTACT US (Hablamos Español)

REFERENCES:

For more information about Document Control Request Form, 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!

Related Articles

Subscribe to get validation
news and free tips by email.

Need Additional Help?

Request for Quotation