8 Factors to Determine Whether a Document Should be Controlled.

8 Factors to Determine Whether a Document Should be Controlled.

 

In this article, you will learn the 8 most common factors to determine whether a document should be controlled by 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.

Figure 1 shows an example of the document control form workflow:

figure 1 - Document control form workflow
figure 1 – Document control form workflow

 

The 8 most common factors to determine whether a document should be controlled by the Document Control Management (DCM) lifecycle:

  1. Does the document guide the production of products (i.e., goods or services) provided by the organization?
  2. Does the document guide the verification, inspection, or testing of products provided by the organization?
  3. Does the document define customer and/or product requirements?
  4. Is the document used for controlling processes?
  5. Is the document used for decision making by production personnel?
  6. Is the document used for collecting data that could be used later for decision making within the scope of the management system (e.g., a form)?
  7. Is the information on the document so critical that failure to keep it updated would pose a risk to the organization or its customers?
  8. Does the document address or relate to a requirement from ISO 9001:?

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

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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 a Document Should be Controlled.

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 how a Document Should be Controlled, 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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