What 12 Types of Controlled Documents Exists?

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.  Moreover, you can discover how to get a Document Management and Control Procedure Template and Document Management Software Application to handle your training activities fast and easily.

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.

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.

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.

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REFERENCES:

For more information about types of controlled documents, refer to:

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

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

httpss://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

httpss://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