7 Best Practices in Document Control Management DCM.

In this article, you will learn the 7 Top Best Practices in 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 Document Control Management System is responsible for the capture, storage, retrieval, coordination, and control of cGMP documents. It is essential to compliance and operational excellence.

One of the most common mistakes that many businesses make is saving digital documents in multiple locations or personal accounts.

Since digital information grows exponentially at an ever-faster rate, this disorganized approach to document management is highly inefficient.

From the time-consuming search for the correct document version to slowed business processes, more mistakes occur and costs rise.

The top 7 best practices in Document Control Management System are:

1. System Ownership and Responsibility.  The system owner is responsible for document revision and approval management. Reviewing and approving documents prior to release under clear ownership of the Document Control Management System. Even though the document control management system involves a group of persons, it requires an accountable person to lead the system.  Indeed, assign this individual the authority and influence over practices, personnel, and budgets—such as management and technical reviewers resources.  The assigned person must have the power to ensure compliance with internal policies, and external legal requirements and regulations.

2. Information Security. Ensuring changes and revisions are clearly identified with the history of change and the audit trail.  Make sure your document control management system is secure. In addition to facilitates the operational effort and support quality assurance and regulatory compliance, the Document Control Management System must be secure. The system needs to be able to limit document access and provide clear audit trails, among other security features.  The sensitivity of data is also important. The system may need more robust capabilities.

3. Contemporaneous Document Control Management. Ensuring that relevant versions of applicable documents are available at their “points of use”. Document management systems have become an important tool for companies to create, secure, and share critical documents. There’s no reason to be doing business via paper anymore.  The electronic document control management must be comprehensive using tags and categories, but also be consistent.

• • Comprehensively tag and categorize: Include the tags and categories necessary for each document. Common tags may include dates, owner, the relevant client(s), and the business unit.
  • Be consistent: The tags and categories must be consistent from document to document to add value and logical sense.

4. Keep Accessibility and Legibility. Make sure the Document Control Management System assure that documents remain legible and identifiable.

5. Sensitive Information Protection. Ensuring that external documents (such as customer-supplied documents or supplier manuals) are identified and controlled.

6. Avoid Mistakes in Document Utilization. Preventing “unintended” use of obsolete documents.  Determine what documents should be retained, evaluating, and classifying them.

7. Users Training. Bring and document the training associate with the document.  A document management system is an integral part of the business filing system.  So, it shall be useful as your personnel is well trained in its operation.

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 formal training to implement the best practices in 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 best practices in 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