How to Prepare for and Pass an Audit – and What to Do Next

    Sooner or later, every life sciences, biotech, pharma, or medical device manufacturer will face an audit. Whether that’s a pre-approval inspection, a routine inspection, a compliance follow-up, or a for-cause inspection will depend entirely on the company’s unique circumstances. 

    While it’s not always possible to know exactly when an audit will occur, your life sciences company can rest comfortably knowing that audits are inevitable. With that knowledge, you can take proactive steps to put your organization in the best position to pass an audit when regulators finally come knocking on your door.

    Qualio’s Director of Quality Kelly Stanton recently hosted a customer panel featuring Gene Vought, Quality Control Manager at Cirris; Nicole Hille, Quality Manager at Aytu BioPharma; and Meg Sinclair, Senior Quality Specialist at Qualio. 

    In it, the group discusses how each of the three companies have prepared for and passed regulatory audits — sharing actionable insights on what your life sciences company can do to replicate that success.

    We’ve summarized some of those tips below. For more, check out the full discussion, which is embedded at the bottom of this post.

    How to prepare for an audit

    As Miguel de Cervantes once wrote, being prepared is half the battle. 

    If your goal is passing an audit, you need to take the proactive steps necessary to put yourself in a position to do exactly that.

    And that’s exactly what Cirris did.

    As a manufacturing company that makes cable and harness testing equipment for an eclectic array of products — including aircraft, catheters, and washing machines — Cirris takes quality management seriously. 

    The company had been using a homegrown suite of software solutions to manage their quality process. As Cirris began trying to achieve AS9100 certification, the company knew it had to transform its approach to quality management and began searching for an electronic quality management system (eQMS). The right eQMS would make the audit process a cinch.

    After searching for solutions, they came across Qualio, and were drawn to the platform’s customizability, which made it easy for them to configure the system in such a way that supported existing workflows.

    “It was an easy decision actually,” Vought says on investing in Qualio. And it turned out to be a wise one, since Cirris achieved their certification.

    Recently, Qualio used its own platform to become ISO 9001 certified. 

    With Qualio’s eQMS, the process was easy; the auditor asked for a list of things they wanted to see, and the Qualio team compiled a document in Qualio, using smart links that enabled the auditor to easily jump from one document to the next.

    But before that, the Qualio team conducted an internal audit on themselves. During that process, they uncovered, documented, and resolved their findings — making it that much easier to achieve the certification.

    “We gave the auditor access to our instance so he could access all the records he needed,” Sinclair explains.

    As you begin preparing for an audit, here are two things to keep in mind:

    1. Make sure you’re using an audit-ready eQMS
    2. Conduct an internal audit first to see what you find

    How to pass an audit

    When you have a robust eQMS in place, not only is it easier to prepare for an audit, it’s also easier to pass one.

    Since Hille joined Aytu BioPharma, the company has been audited five times. Thanks to Qualio, those experiences were painless. The Aytu BioPharma team simply collected all the documents they needed from Qualio and sent them to the auditor electronically.

    “We really have not experienced any issues,” Hille says. “Qualio’s been a great system to use for the audits. Our auditors have been impressed by it.”

    Cirris had a similar experience, with one difference: They gave their auditor direct access to Qualio, and let them dig around the information they needed at their own pace.

    The Qualio team took a similar approach, adding an auditor tag to the documents they wanted the auditor to see.

    “You can give them full access but limit what they see within that,” Sinclair says.

    As you approach your audit, remember to:

    1. Give auditors electronic access to the documents they’re asking about — whether that’s directly in your eQMS or some other way is up to you
    2. Restrict access to documentation and other proprietary data that fall outside the scope of the audit

    What to do after an audit

    Once an audit’s wrapped up, you’re likely to have findings. What you do next is what’s most important.

    According to Hille, the Aytu BioPharma team added the auditor’s findings into Qualio through its Events feature and used Events workflows to ensure the resolution of each of them.

    “We’ve been able to move past everything pretty flawlessly,” she notes.

    While somes teams might be a bit upset at an auditor’s findings, Vought suggests your quality team take a different approach.

    “We don’t get upset when an auditor finds something. I thank them because they’re helping us better ourselves,” Vought says. “That always makes the auditor feel better, too. You can tell that they’ve been yelled at by other people.”

    For the best results, think about building a relationship with your auditor and contacting them periodically for advice.

    “That way, they see your system, and they get confident in what you’re doing,” Vought concludes.

    After your audit is in the rear-view mirror, here are two tips to keep in mind:

    1. Document your findings and make sure you follow up on them
    2. Treat your auditor with respect and form a relationship with them

    Check out the full discussion to learn more about what your organization can do to prepare for and pass an audit — and what you need to do after that.