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Document control systems are the backbone of quality management systems in the medical device industry.
Documentation promotes collaboration within design teams as they define inputs, track changes to a device, and affirm that the device meets the needs of users. Management uses documentation to communicate standards for quality procedures and best practices. And let’s not forget the crucial role documentation serves for demonstrating compliance with regulatory requirements.
With so much depending on your documentation, it’s safe to say that your company’s success depends on how you manage and control documentation in all aspects of your work.
But what exactly is document control? What are the regulatory requirements for a document control system? And what options do companies have who are looking to improve their approach to document control? Let’s dive in.
Document control refers to the policies and procedures medical device companies use for organizing, routing, and distributing the many documents that flow through different departments, stakeholders, and third parties.
Document control has to happen over the total product lifecycle. As a result, document control extends to various postmarket surveillance processes, such as customer complaints and the use of corrective and preventive actions (CAPA).
Some of the most common forms of documentation for medical devices include:
Device History Records
Device Master Record
Design History Files
The purpose of document control is to ensure that there is organizational accountability for documents that are used to satisfy quality requirements.
To do so, any well-defined document control approach will include the following five steps:
Review and approval
A document control system is a combination of the processes, workflows, and software solutions used to ensure proper document controls are in place. Document control systems should seamlessly integrate with your QMS processes.
While your approach to a document control system is undoubtedly your own, it should at minimum be able to support document creation, storage, issuance, changes, reviews, approvals.
Document control systems should also handle all types of documents, including checklists, reports, drawings, specification files, and forms. And of course, document control systems need to process change requests efficiently, including generating the required records of changes made.
By using a well-defined and thorough document control system, medical device manufacturers will often see improvements across the organization in a variety of ways. Some common benefits to document control systems are:
More accountability around business practices
Greater responsiveness from stakeholders
Greater document security
Access to documentation
Document control systems are a common requirement of regulators around the world. Understanding these regulatory requirements is crucial for a proper document control system to work.
Let’s take a look at what regulatory agencies in the US and EU markets are expecting to see from your document control system.
The FDA addresses document control in its quality system regulation, 21 CFR 820.40. The legislation indicates three areas of focus for document control:
Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented
Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective
Document control systems must also comply with 21 CFR Part 11, which states that companies using electronic records shall “secure, computer-generated, time-stamped audit trails to independently record the data and time of operator entries, and actions that create, modify, or delete electronic records.”
Understanding the requirements of Part 11 is essential for medical device organizations to be sure they are administering compliant electronic record-keeping systems, properly using electronic signatures, electronic signature components, and controls for codes and passwords.
EU MDR emphasizes a focus on the total product lifecycle, including post-market surveillance.
The associated requirements necessitate a document control system that can produce items like a post-market surveillance report, which summarizes the results of all your post-market surveillance data, including any corrective actions.
Higher-risk devices may demand an even more rigorous documentation system to produce items, such as a periodic safety update report (as noted in Article 86), that require annual updates.
Article 25 of the regulation also designates the “economic operator” status to distributors, importers, and EU-authorized representatives—each with its own documentation standards.
The best document control systems are purpose-built for the medical device industry that facilitate the design, development, manufacturing, and distribution of safe and effective medical devices to end users.
With Greenlight Guru your documents, rather than being a tangent to your core processes, can take a central role in a connected quality ecosystem. With a purpose-built system, you can track and update documents throughout the lifecycle of the product, maintain closed-loop traceability, and integrate all the quality processes, design inputs, and risk data you need.
Interested in learning more? Contact us today for your free personalized demo of Greenlight Guru →
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...