What 12 Types of Controlled Documents Exists?

Types of controlled documents as per Document Control Management DCM

 

In this article, you will learn about the 12 types of controlled documents required by current Good Manufacturing Practices cGMPs and covered by Document Control Management DCM.

The 12 most common types of controlled documents according to cGMP and DCM are summarized below.

Document management controls are intended for cGMP documents stored either manual or electronic, to provide evidence that the QMS Quality Management System documentation and its related forms are under control —such cGMP types of controlled documents are:

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

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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.

TO PURCHASE A TEMPLATES PROCEDURE, click here.

CONTACT US IF NEED HELP TO MAKE OR REVIEW ANY TYPE OF CONTROLLED DOCUMENTS.

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For more details on specific FDA expectations and types of controlled documents, follow us.

Quality procedures templates

Three (3) Options to Create Controlled Documents:

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

You can download samples of different types of controlled documents, procedures, and 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 formal training on how to prepare different types of controlled documents.

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 types of controlled documents, 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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