Audits are a necessary part of launching a medical device onto the market, and companies can easily and effectively perform them on-site or virtually.
Image Credit: DSI, a PLG Company
Here’s a quick breakdown of formal and informal audits:
Audit (formal) – the annual ritual of providing objective evidence that a quality system is established, followed and effective. A good quality system will support regulations and ensure a company has consistent accuracy and precision across all products.
Audit (informal) – the annual ritual of hosting vendors-turned-acquaintances on-site to provide them with procedures, documents, reports and records going back several years even though you are not currently operating under the same versions of the procedures (or, anything in the vicinity of similar). This is a time when you spend your entire day—or days—sitting at a conference table answering questions and fetching more documents while your work continues to pile up.
What Types of Audits are Being Performed?
1. Internal Audits: Not all companies are equipped with an internal audit team that satisfies the “no conflict of interest requirement.” Full company quality systems audits conducted annually can satisfy requirements for departments without any issue.
2. Supplier Audits: Depending on their level of risk, suppliers may be audited annually or every two to three years. Contract manufacturers are always deemed “critical,” and self-audits and questionnaires are not sufficient for higher-risk suppliers.
3. Pre-Agency Audits: These preventative audits are done before the FDA or notified body to ensure companies are prepared to address any issues.
4. GAP Assessment Audits: When companies decide to market their medical devices in new countries or to release a new standard, such as the EU’s Medical Device regulation, they typically proceed with GAP assessment audits to ensure the company is ready for its next agency audit.
5. Medical Device Single Audit Program (MDSAP) Audits: These four- to five-day-long audits are meant to limit the number of countries that can audit a legal manufacturer. Countries that have agreed to accept the results of MDSAP Audits include the United States, Australia, Brazil, Canada, Japan and the European Union. After auditors complete MDSAPs, none of the auditing countries previously listed should request further audits to the manufacturer.
Setting up a Virtual Audit
- Step 1: Appoint a qualified auditor after reviewing their resume/CV, training certificate and the number of virtual audits they have previously performed.
- Step 2: Agree on an audit schedule based on the size of the company and the number of products.
- Step 3: Submit an audit plan to the auditee so they can prepare prior to conducting the audit.
- Step 4: Grant access to the quality system and documents necessary for the audit to team members working on the project.
Performing a Virtual Audit
Your project manager should schedule an opening meeting each morning for all attendees. The first opening meeting will typically identify company history, principal employees, device descriptions and facility tours, as well as functions that are carried out on-site at any relevant facility that falls under the remit of the audit. Following opening meetings should provide time for the auditor and auditees to address and answer questions, follow up on non-conformances and note the day’s tasks. Audit trails, or lists of notes, questions and requests for documentation should be noted for compliances purposes.
Closing meetings should be held each afternoon to identify non-conformances and related objective evidence. On the final day of the audit, the closing meeting should cover all non-conformances to ensure everyone is in agreement.
Conducting a Virtual Audit Report
Virtual audit reports are essentially managed in the same manner as on-site reports. The author will use a template to record that all documents, as well as their titles and revisions, have been reviewed. Each report should contain a clear, absolute conclusion as regulatory agencies will be reviewing the information.
Should My Company Use an On-Site or Virtual Audit?
Virtual audits allow companies to save money on auditor travel and allow employees to continue working during the project. On-site audits are recommended for deep dive projects, though both can run smoothly if companies can provide access to the necessary systems and documents.
About DS InPharmatics LLC
DS InPharmatics (DSI) provides regulatory, technical, and project management consulting services to healthcare product companies that manufacture and/or market pharmaceuticals, biopharmaceuticals, and cellular and gene therapy products.
Since 2007 we have provided our clients with innovative strategies and exceptional quality work products intended to enhance product development, approval, and marketing presence. Whether advocating CMC strategy, directing CMC operations or developing CMC submission content that represent the best interests of emerging biotech, we focus on the critical CMC issues and build programs that enhance development.
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