Medical device manufacturers that wish to market their products for sale in the United States are required by the FDA to comply with the quality management regulations set forth in 21 CFR Part 820. These regulations establish detailed quality management requirements for medical device manufacturers that address the need for documented design controls, corrective and preventive action procedures, and a host of other quality processes that ensure medical devices are safe and effective for the intended user.
While over 50% of medical device companies still use paper-based QMS systems, these systems are in fact the riskiest way to manage medical device projects. For this reason, an increasing number of medical device companies are adopting electronic quality management systems, or eQMS, to support their compliance with the FDA and ensure that newly designed medical devices are safe and effective for the intended user.
Across the world, industries are undergoing
1. Missing documents
A paper-based filing system typically lacks the checks and balances to ensure that it is always up-to-date with the most current document versions. If a document is lost or misplaced when it is removed from filing for review or to make a change, the manufacturer may not be aware of this until an FDA auditor is asking for the document. An eQMS offers medical device manufacturers significantly better oversight into the presence and completeness of QMS documentation - and makes lost documents a thing of the past.
2. Missing signatures
The FDA mandates a rigorous approvals process for documents that appear in the QMS. Medical device companies must designate an individual, typically the Quality Manager, to review and approve a variety of documents within the quality management system. Document changes also require
3. Lack of document controls
The FDA quality system regulations require that medical device companies establish and maintain document controls that satisfy the requirements of 21 CFR Part 820. Document controls include the requirement for approval signatures on all documents established to meet the quality system guidelines, along with additional requirements for ensuring that the most up-to-date documents are available everywhere they are designated, used or otherwise needed. The adoption of an eQMS that supports document version control helps to ensure that the most current approved documents are always readily available - for reference, or in
Greenlight Guru is the only eQMS software built specifically for the compliance and quality assurance needs of the medical device industry. Greenlight Guru was designed for out-of-the-box, 1-to-1 compliance with the most current regulatory requirements for medical device companies: The FDA QSR (21 CFR Part 820) and ISO 13485: 2016.
In addition to supporting compliance, Greenlight Guru eQMS software helps medical device companies manage workflows, reduce risk and improve time to market. Medical device companies can use Greenlight Guru to better align their processes, establish linkages between user needs, design outputs and known sources of risk, and easily produce documented evidence of effective quality practices.
Greenlight Guru's eQMS software serves as a single source of truth for your medical device company, ensuring that all required quality system documentation is localized in one single platform, securely stored in the cloud, and that the newest versions are instantly accessible by all persons with access to the system - that means automated document controls and no more missing documents.