Medical device manufacturers are required to produce safe and effective products that comply with the FDA’s regulatory requirements. Since the ultimate users of medical devices are not in a position to compare the relative safety and effectiveness of products, Congress holds manufacturers to high standards for product quality. Companies and the responsible individuals can be held criminally liable if their products are not safe or effective.
They can be prosecuted even if they’re not aware product problems exist.
So what type of conduct is expected? According to the Supreme Court in United States vs. Park, 425 US 658 (1975), “[T]he Act imposes not only a positive duty to seek out and remedy violations when they occur but also, and primarily, a duty to implement measures that will insure that the violations will not occur.”
The FDA, in the Quality System Regulation, 21 CFR 820.22, requires manufacturers to establish procedures for quality audits and conduct such audits to assure that the quality system complies with requirements and is effective. The regulations go on to require that a report must be made of the audit (or when applicable re-audit) and this report is to be reviewed by management having responsibility for the matter being audited.
The FDA’s expectations pertaining to the need to conduct audits and how audit results are to be handled are specifically stated in the regulation. However, medical device companies are given wide latitude as to the manner in which they can fulfill their obligations.
Companies are using electronic systems to record the results of the audit, prepare audit findings and to monitor the implementation of corrections, corrective actions and preventive actions with respect to the audit findings.
The benefits of an electronic system vs. a paper system are numerous. With a paper system, there can be a lack of uniformity in how different auditors record findings. Additionally, the reports generated from the findings will be subjective, influenced by the person writing the report.
Keeping track of who is responsible for taking follow-up action may also be a time-consuming process.
Since the primary purpose for a company to conduct internal audits is to ensure effectiveness in their manufacturing operations and provide continuous improvement, an electronic system can assist with these detailed process requirements. There will be greater uniformity in the observations as the auditor fills in fields rather than writes an unstructured narrative. The audit report will be uniformly formatted, so the reader can quickly grasp the information.
Additionally, a matrix of who is expected to take what type of action according to a projected timeline will be visible to those with specific tasks and those responsible for providing oversight.
Although there is a cost to purchase an electronic system in the short run, in the long run companies will save money. With an electronic system, the staff will be more efficient in recording data that expose non-compliance with regulatory requirements and taking action to correct volatile situations.
Management will gain confidence that they have provided the tools to achieve and maintain a quality system that can produce safe and effective products.
Nancy Singer founded Compliance-Alliance, LLC to specialize in the professional development for those employed in the medical device industry. Nancy began her career as an attorney with the United States Department of Justice where she did litigation for the Food and Drug Administration. Subsequently she was a partner at the law firm of Kleinfeld, Kaplan and Becker. She provides consult services for leading quality control software provider Sparta Systems, Inc.
Edited by
Braden Becker
