What is a Document Control System?

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 that are looking to improve their approach to document control? Let’s dive in.

BONUS RESOURCE: Click here to download a copy of The Ultimate Guide to Document Control for Medical Devices.

What is document control?

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

• Quality Procedures

• Work instructions

• Quality Records

• Quality manual

• Drawings

• Forms

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:

1. Document creation

2. Review and approval

3. Revisions

4. Publishing

5. Deletion/Disposal

What is a document control system?

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, and 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 of document control systems are:

• More accountability around business practices

• Greater responsiveness from stakeholders

• Greater document security

• Access to documentation

• Easier compliance

What are the requirements for document control systems?

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.

FDA requirements for document control 

The FDA addresses document control in its quality system regulation, 21 CFR 820.40. The legislation indicates three areas of focus for document control:

• Document Approval

• • 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

• Document Distribution 

  • The approval, including the date and signature of the individual(s) approving the document, shall be documented

• Document Changes

• • 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 Medical Device Regulation requirements for document control

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.

BONUS RESOURCE: Click here to download a copy of The Ultimate Guide to Document Control for Medical Devices.

Why does choosing a purpose-built document control system matter?

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 →