To comply with the FDA's quality system regulations, medical device companies should develop a document control plan that elaborates how they will control documents generated through quality activities.
In 21 CFR Part 820.40, the FDA details its document control requirements for medical device companies. Medical device manufacturers are responsible for establishing and maintaining procedures to control all documents outlined in 21 CFR Part 820, including product and supplier controls, design control documentation, CAPA, and standard operating procedures (SOPs).
A document control plan is a document created by a medical device company which outlines how the company will approve documents, make them available for use wherever needed, remove them from circulation whenever obsolete and control the change process for documents. While the FDA's regulations do not dictate exactly what procedures medical device companies should use, they do create specific document control requirements that apply throughout the QMS. Medical device companies have some flexibility when it comes to establishing a document control plan, provided it meets the requirements of 21 CFR Part 820.
What Document Controls Are Required For Medical Device Companies?
The FDA's document control requirements help to ensure that documents in the quality system have undergone an adequate approval process. Medical device companies must designate an individual to review and approve all documents that are subject to the requirements of 21 CFR Part 820. In addition, all document approvals must also include a date and a signature.
Document controls help to ensure that staff members or manufacturing operators for medical device companies can access the most current and up-to-date specifications and safety information. Approved documents in the QMS must be made available at all locations where they are needed, and obsolete documents should be immediately removed from circulation wherever they are used.
Medical device companies are also responsible for keeping track of how documents are changed over time. Change records should include a description of the change, which document was changed, signatures, the date when the change was made and the effective date of the change. When a document is changed, it should be re-approved by the same individual within the function or organization that originally approved the document.
What's in a Document Control Plan?
A document control plan satisfies the requirement that medical device companies have to establish and maintain document control procedures. It describes how the medical device company will organize itself to meet the requirements of 21 CFR Part 820.40. A typical document control plan includes the following:
- Purpose and Scope - A brief description of the plan, its purpose, and what documents are covered by the plan.
- Roles and Responsibilities - A short summary of the roles and responsibilities from within the organization, as they relate to the document control policy. This is where medical device companies should designate someone responsible for approvals, typically a document manager or a quality manager.
- Related & Supporting Documents - A list of related policies that someone reading the document control plan might want to reference. A list of supporting documents that could include work instruction templates, SOP templates, and any other pertinent information.
- Document Control Process - A detailed description of how the document control plan will be carried out in compliance with 21 CFR Part 820.40.
Greenlight Guru is Configured To Meet The FDA's Document Control Requirements
Greenlight Guru is the only Quality Management Software Platform that allows for near zero effort validation to FDA’s 21 CFR Part 11 electronic document control requirements. This software solution, specifically designed for medical device manufacturers, features a robust document repository with built-in approval workflows and automated document change records.
With the Greenlight Guru’s QMS Software, industry professionals, and document managers in particular benefit from a streamlined process that supports quality and compliance. Users can safely and instantly approve documents across multiple channels with the click of a button, easily ensure that obsolete documents are removed from circulation and automatically generate change records. Our document management system has been built on innovation to eliminate the tedious tasks associated with paper and Word-based systems.
Greenlight Guru helps medical device companies increase efficiency and get to market faster with industry-leading document management functionality. Greenlight Guru's new advanced document management system offers top-tier security features while maintaining complete visibility and transparency throughout your medical device lifecycle.