Medical device companies that wish to sell their products around the world must comply with the document control standards set forth by regulatory bodies that legislate the quality system requirements for each marketplace.
Document control standards have historically been included in quality system regulations across industries for some time. Historically, organizations that managed a high volume of documents frequently hired a document manager whose role was to manage the documents in compliance with applicable document control standards. Today, innovative eQMS software solutions can help companies automate or streamline many aspects of the document control process.
The purpose of document control is to manage the information that is transmitted between relevant parties within and outside the organization. If an operator needs to review the SOP for a particular manufacturing step, they must be able to access the correct information in a timely manner. If the information must be changed, there should be a process for tracking and approving those changes. Once a change occurs, the operators need access to the new document and the outdated version should be discarded. All of these processes and functions are facilitated by document control standards.
Document Control Regulations In The FDA QSR
While the FDA QSR does set requirements for document control, it would be wrong to call those requirements a "standard." An important distinction exists between standards and regulations - if you fail to meet a standard, you may simply not qualify to sell in that market, whereas a lack of compliance with regulations could mean financial or legal penalties and not being allowed to sell the product.
The document control regulations in the FDA QSR require medical device companies to designate a responsible person to review and approve documents, ensure the availability of current documents, prevent the unintended use of obsolete documents, keep records of document changes and conduct re-approvals whenever a document is changed.
Document Control Standards: ISO 13485:2016
The most relevant document standards today come from ISO 13485:2016, the leading international standard for medical device quality systems. Medical device companies that wish to sell products throughout the European Economic Area must comply with the document control standards of ISO 13485: 2016, which include provisions for:
- Document review and approval
- Reviewing, updating and re-approving documents
- Recording the current revision status and changes to documents
- Ensuring that relevant versions of applicable documents are available at points of use
- Ensuring that documents are legible and identifiable
- Controlling the distribution and identification of necessary documents of external origin
- Preventing the deterioration or loss of documents
- Preventing the unintended use of obsolete documents
Looking Ahead: Document Control Standards In The MDSAP
The world of medical device regulation is moving towards a new regulatory strategy known as the Medical Device Single Audit Program (MDSAP). Collaborating countries in the MDSAP include Australia, Brazil, Canada, Japan, and the United States. The goal of the MDSAP is to allow medical device companies to sell products in multiple international markets based on the results of a single audit. The current document control standards of the MDSAP list the following requirements for medical device companies:
- Approve documents for adequacy prior to use
- Review and update as necessary and re-approve documents
- Ensure that changes and the current revision status of documents are identified
- Ensure that relevant versions of applicable documents are available at points of use
- Ensure that documents remain legible and readily identifiable
- Ensure that documents of external origin determined to be necessary for the planning and operation of the QMS are identified and their distribution controlled
- Prevent the unintended use of obsolete documents, and apply suitable identification to them if they are retained for any purpose
Medical device companies should take note that the MDSAP requirements are largely based on and drawn from the requirements of ISO 13485:2016. As we move towards adopting a single audit program for medical device companies, manufacturers should prepare to meet the document control standards outlined in ISO 13485 and the early MDSAP guidance.
Greenlight Guru Helps Medical Device Companies Meet Document Control Standards
Greenlight Guru's Quality Management Software platform ensures that medical device companies can always access their most up-to-date SOPs and quality documentation at the relevant point of use, while automating change records and preventing document loss. Greenlight Guru makes it easy for quality managers to approve documents, re-approve changed documents, and remove obsolete documents from circulation at the click of a button.
Greenlight Guru is the only eQMS designed for medical device companies as an out-of-the-box solution. The platform comes fully compliant with the most current document control standards built-in, meaning less customization and reduced time for device companies to bring their product to market.