Any organization to comply with statuary requirements requires a regulated process for document change control especially the ones that belong to the pharmaceutical and medical device industry. These industries need a strategic approach to manage the changes in the controlled documents to ensure that every change made follows cGMP and relevant regulatory standards.
What are Controlled Documents?
Controlled documents are the ones that must undergo a regulated and defined process for review, approval, distribution, modification, storage, access, and even deletion. In simple words, a controlled document undergoes standardized processes to manage change and compliance.
ISO 9001:2015 also requires organizations to manage controlled documents for the effective functioning of the quality management system.
What is Document Change Control?
Document change control is all about establishing a streamlined process for transmitting critical information between the involved parties.
As per ISO, Document Change Control can be referred to as control on:
- Approval of important documents based on adequacy before issuing them to the relevant parties.
- Review and document updates as and when required. (It may include reapprovals as well)
- Changes and revisions status of the controlled documents.
- Availability of relevant and most recent versions of the documents at the time of use.
- Legibility of the documents for easy identification.
- Distribution of the external documents in the organization especially the one that comes from subcontractors or suppliers.
- Unauthorized use of controlled documents.
However, the control procedures are applicable to documents as well as records. You must be wondering What’s the difference.
Well, documents include Quality manual, Quality procedures, Technical designs and drawings, Presentation, Recipe while records include Training certificates, Audit findings, Feedback questionnaire/survey, Meeting minutes, order receipt, etc.
Some organizations even have the document controllers to classify the specific documents that must be controlled. Their key role is managing the controlled documents using a set of industry best practices and processes.
What Document Change Control Process is Intended for?
Document change control helps organizations to keep consistency, quality, and compliance of the documents in check. A well-established control process helps to reduce the errors in the critical documents and avoid the inconsistent flow of information. This further ensures that the quality quotient of the end-product doesn’t get affected even if the person at duty changes.
Document change control also improves the reliability of a document, ensuring that it has already undergone a regulated process of review and approval. However, you can also prepare a document control checklist to ensure a compliant process.
How to establish a compliant document change control process?
The conventional change control processes may not be effective since the organizations are shifting to digital documentation. The best way to manage the new-age trend of digitized documents is an electronic document and change control management system.
Most of the document change control management solutions are designed to comply with FDA 21 CFR Part 11 quality standards for documentation including Electronic Signatures and comprehensive Audit Trails.
How a Document Change Control Software can help?
Investing in a specialized document change control management software can help you align the controlled document changes and upgrades with the quality objectives through:
- Initiation and Documentation of Change
- Effective Review & Approval of Change
- Notification of Change to the Impacted Users
- Implementation of the Change
- Automatic Creation, Revision, Expiration, and Archival of your Controlled Documents
- Ensuring Regulatory Compliance
When you have a document change control management software in place, you can initiate and document the change requests systematically. It enables you to store every important information about the change request made including the date, type, justification, priority, the owner of the request and much more.
Documenting the details about change requests can serve as an easy reference for the future if the same request is investigated. It can be a source of evidence too to make informed business decisions.
The change request cannot be processed until it is reviewed thoroughly and approved by the management. A change control software can help you perform different types of reviews including management review and analyze those review results before you approve any change request.
Reviewing and approving a change in the controlled documents is a critical function to be performed and requires utmost precision and accuracy that you can ensure with a change management software system.
In addition to documentation, review, and approval of a change request, a change control management software solution also helps you to notify the change to the impacted users. It gives them enough time to identify best practices to implement the document change within the specified time without any hassles.
A software can help you inform all the impacted users at the same time to ensure no harm to the on-going processes and productivity of your team. This makes your team ready for the change and organizes their workflows accordingly.
Keeping your quality teams and processes informed and aligned with the upcoming changes helps to reduce the change implementation cycle time significantly. A document change software also enables you to configure the workflows based on best practices of change implementation.
An effective software helps to track and to manage end-to-end change processes for multiple change requests at a time that cannot be efficiently done through manual practices of change management and implementation.
Version control and archival of the controlled documents is one of the critical functions to be taken care of during the change management process, which may turn tedious with the traditional paper-based management systems. On the other hand, change management and control software can help you manage all the activities including automatic creation, revision control, expiration, and archival of your controlled documents.
A software helps you to ensure that your quality teams refer to the most recent version of the controlled documents by keeping control of revisions.
The advanced document change control solutions are designed to comply with FDA 21 CFR Part 11 quality standards for documentation so that the organizations can leverage the electronic signature and audit trail. This ensures that only validated and verified information is circulated through the organization.
Hence, using software ensures regulatory compliance for your document change control processes.
A powerful change management software solution also gives you greater visibility into your change processes and reinforces benefits like:
- Reducing the time to implement a Change
- Getting Better Understanding of Growing Customer Needs
- Establishing Best Practices to Achieve Business Goals
- Defining Operational Workflows to meet Industry Regulations
- Attaining Excellence in Business Performance
Wouldn’t you like to standardize the change management processes across the organization to improve your product and quality processes?
So, get an effective change management software like Qualityze today. You can test its functionalities for free by requesting a free demo.
The cherry on the top: You will also get the 1-week product trial for free.