When is necessary Document Control Management DCM?

In this article, you will learn when is necessary a Document Control Management?  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.

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 labelling 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 clean rooms
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 labelling processes
    10. sterilization process
    11. storage, shipment, or distribution processes.

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))

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

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

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.

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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 when is necessary a Document Control Management.

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 when is necessary a Document Control Management, 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