Article Context:

1. Document Design Control Why DCC?
2. FDA 21 CFR Part 11
3. FDA 21 CFR Part 820.40
4. ISO-13485:2016
5. How to implement a Document Change Control-DCC?

In the life sciences industries, documentation plays a crucial role in proving the product’s effectiveness and safety. Furthermore, it discusses the processes and practice’s dependability, repeatability, and reproducibility. Documents describe methods and techniques around the organization, ensuring effective communication about what to do, when, and how to do it. In contrast, document change control (DCC) will manage and control the documentation change. Therefore, document change control (DCC) denotes the documentation process.

Why DCC?

Document management and document control are two criticisms of a document management system. Document management refers to an organization’s processes and practices for managing and maintaining verified documents like storage, location, tracking, updating, and sharing. In contrast, document control is a set of practices that define the creation, review, approval, and distribution of verifiable documents adhering to regulations and compliance.

Since the documentation is critical and a mainstay for life sciences industries to prove their product safety. ISO standards govern it with the following guidelines – FDA 21 CFR Part 11, Part 820.40, ISO 13485:2016, and GxP.

FDA 21 CFR Part 11

FDA 21 CFR Part 11 is a standard that ensures organizations comply with electronic records and electronic signatures; if the organization is paper-based and shares the documents via email or sharing platform, as per these regulations, the company should comply with 21 CFR Part 11 by securing the computer-generated time stamps, reviewer entries, and changes. So instead, the FDA regulation will fit in by adopting a DMS. The DMS will suffice validation requirements, document creation, storage, security, access controls, change controls, tracking, life cycle management, electronic signatures, and audit trails.

FDA 21 CFR Part 820.40

FDA 21 CFR Part 820.40 is a standard for document control by the US government for the US market’s medical device sellers and manufacturers. According to this regulation, the companies should maintain procedures and processes to control the relevant documents complying with FDA’s quality system regulations.

ISO 13485:2016

ISO 13485:2016 – an international standard highlighting the importance of document change control of life sciences documents. In addition, the standard put forth the requirement of computer system validation for companies that use the Quality Management System (QMS) and Document Management System (DMS) for creating and managing records and documents.

The above-stated standards are connected, and when companies start to comply with one standard eventually comply with all.

GXP

GxP – quality regulations and standards to ensure the life sciences products are safe and manufactured, abiding the quality practices and procedures and adhering to compliance during development, storage, and marketing. GxP stands for Good, x varies with the application, like C for clinical, M for Manufacturing, etc., and P for Practices. It is established to conform the companies on the following,

The person is responsible for the quality practices, processes, and procedures.

Track the process from procurement to development and marketing Data integrity.

How to implement a Document Change Control-DCC?

An effective Document Management Software (DMS) allows the organization to effectively organize, streamline and manage documents throughout their life cycle. In addition, the DMS will enable the creation of a set of procedures and practices to manage document management and document control tasks like the approvals, reviewal, versioning, archiving, and numbering aligned with the relevant regulations like FDA and ISO.
QMS integrated DMS web-based application allows role-based accessibility to document the quality processes and procedures and effectively track, manage, and store the documents. In addition, the QMS allows record creation and investigation of the root cause of quality issues and effectively correct and prevent them. Also, it provides a holistic view to link the documents with the quality issues enhancing decision-making abilities, visibility, and actionable insights.

With the help of QMS Software – DMS, organizations can effectively manage document change control procedures. The DMS is customizable and designed with automation. The system differentiates the documents into controlled and uncontrolled and makes it simple to manage the document life cycle. While creating the document allows the users to choose the predefined workflow with approvals and reviewers defined; therefore, the document is approved by the right people before making it effective. Further, the automation validates the document changes and controls the versions with the organization-led change request processes. The document change control process safeguards the changes, and the documents are made effective and or obsolete with change requests approvals. The change requests, document reviews, and approvals are notified to the right person at the right time for action from them. The data is securely stored on the redundant cloud and is limited to user access as the organization requires, and subject matter experts render 24/7 support.

Information and documentation are a constant part of the life sciences industry. Therefore, a proper flow of information must be maintained and accurate, accessible, secure, and current. Document control processes and procedures can help achieve all of these goals.

QMS Software integrated with DMS enables the organization to manage all QMS and DMS processes confidently in adherence to the regulatory standards such as FDA 21 CFR Part 820.40, FDA 21 CFR Part 11, and GxP.