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Audit Readiness: High. Stress: Low

Whether you’re a CRO being constantly audited by your Sponsor, or part of a pharmaceutical company preparing for your first FDA Pre-Approval Inspection (PAI), in our industry we must always be audit and inspection ready.  As the compliance manager of a software company that caters to the highly regulated pharma, biotech, and medical device industries, I have the privilege of constantly “hosting” our customers during their vendor qualification and re-qualification audits.  Or, I should say “e-hosting”?

That’s right, the need for hosting onsite audits is a thing of the past for SureClinical.  So, how does a remote audit work?  Through the SureCompliance Portal, I manage all the relevant compliance documents to support our customer’s vendor qualification process.  The SureCompliance Portal helps us stay audit ready at SureClinical. What’s even more important, is that our customers also leverage the portal when they are audited.  

The word “audit” tends to evoke fear in the hearts of most people. Having been in Quality Management for years, I’ve been through countless audits.  The truth is, audit readiness can be surprisingly effortless once the appropriate systems are in place. 

I’ve put together some advice on how to keep audit-readiness high and stress levels low.  Included is also guidance from my mentor and VP of Quality, Martin Dearden.   Whether you’re just starting out, or have a renewed commitment to audit-readiness, here are our tips for what you can do to make sure your GxPs are in a constant state of control.

5 Tips for Audit Readiness

1. Start with the basics

To quote compliance managers, go after the “low hanging fruit.”  Pay special attention and maintain systems that are highly visible during an audit or inspection: interactions with employees and facility tours.  Set up systems to constantly monitor areas such as employee Training and Qualifications, and the Lab/Manufacturing facility (cleanliness, organization, non-expired materials, equipment calibrations up to date, etc.).

2. Stay up to date

 Having been part of many audits as both auditor and auditee, I have learned that we have close predictions as to what FDA inspectors and auditors will want to focus on. From having 24/7 access online to current regulations, guidelines, and even current trends on FDA-issued 483’s, to relying on previous audit and inspection reports, you usually have a good idea of the areas an auditor will want to focus on.  Use the past to predict the future. Be a few steps ahead.

Martin’s Advice: Read your EIR or Establishment Investigation Report. This will usually contain insights from the investigators as to how they felt the previous inspection went.  It may also contain recommendations for the upcoming inspection, comments on the complexity of your site or operation. All in all, they are a great addition to the lexicon of documents available to you for readiness.

3. Have thorough documentation

Of course, implementing and abiding to standard operating procedures (SOPs) hold the key to remaining audit ready, but also how you document the evidence and rationale behind your actions are key.  Having strong documentation is equal to having a strong argument if the process gets challenged.  Having online platforms and electronically controlled documents make audit prep a breeze.  At SureClinical, I use our SureDrive product to host all of our compliance documents.  With audit trail and e-signatures, I find it is easy to keep documents current and accessible. 

4. Prepare your people

It is not rare that employees will serve as SMEs during an audit or inspection.  It is a good idea to hold seminars and 1-1 trainings for employees likely to be interviewed by an auditor.   Setting expectations, including advising on appropriate etiquette and interactions with the auditor are essential to maintaining a positive and productive audit environment.  Be ready and have pre-selected, well-informed personnel and backups for roles during the audit: host, co-host, runners, scribes, personnel in the War room, etc.   Hosting a mock audit is always helpful and a smart investment.

Pro Tip:  to give people some perspective, it helps to get them involved during an audit.  From being a runner, to serving as a scribe, there truly is nothing like sitting in the same room as the auditor, hearing their feedback and perspective on your company’s processes

Gone are the days of document storage rooms

5. Create a quality culture

This is every Quality department’s goal.  Let’s be honest, not everyone is onboard with the whole Quality and Compliance “rigidity” and need for documentation.  I rarely see a smile after uttering the words “We need to open a CAPA.”  To get people on board, keep processes simple and be consistent.  Regardless of the apparent pains of “documentation,” with proper training and consistency people are bound to understand the need and importance for Quality and Compliance, and often become Quality advocates themselves!   This type of mentality and culture is essential to having everyone contribute to the audit readiness program. 

Martin’s Advice: Ensure your Quality Culture sets Quality Key Performance Indicators (KPIs) that contribute to understanding how your QMS is working in practice. Use statistics in a way that benefits understanding and simplify decision making. Understanding this internally makes explaining the system performance to investigators a pleasure (hopefully). Use the FDA’s own recommendation for suitable targets for monitoring, make sure these indicators are reviewed regularly. Make compliance a consequence of your quality culture and way of working, not a target.

#Belikecharity

Being audit-ready shouldn’t be a daunting task.  It should be a series of short but constant efforts.  If you have well-defined processes and tools, managing an audit can be as easy as providing access to those tools to auditors with a little bit of oversight thrown in. Case in point: at our recent Lunch & Learn series, our guest speaker, Charity Cowley from Clinilabs, casually brought up that she was in the middle of an audit as she was traveling around the country.  That definitely got  a reaction from my peers.  Her response: “I just provide them access to our SureETMF and process documentation online in SureDrive and make myself available for questions.”  Easy. When you follow a consistent readiness process and have access to FDA and EC-compliant tools like SureClinical, we can all #belikecharity.

How do you prepare your company for audits?  Join the conversation and share your best tips below. 

About the Authors

Melissa is a registered Quality Assurance Professional in Good Clinical Practices with the Society of Quality Assurance. She has a multidisciplinary background starting off her career in the laboratory (R&D) and Quality Control, serving as an SME during FDA inspections.  She transitioned to a role in Quality Systems and Clinical Quality Assurance in the bio-pharmaceutical industry, where she conducted clinical site and vendor audits, and further supported FDA inspections and client audits. She is SureClinical’s Compliance Manager, hosting client audits and maintaining the company’s compliance systems.  She also serves as a Product Owner for the new SureQMS product.   When not creating a quality culture at work, you can find Melissa enjoying family time or at the dog beach at home in San Diego.

Martin is Vice President Pharmaceutical Quality Assurance with extensive global manufacturing and product development QA experience covering over 30 years. Microbiologist and Qualified Person (Permanent Provisions) with detailed knowledge of EU and USA regulatory / GMP expectations and hands on experience of FDA, MHRA, EMEA and Japanese inspections. Experienced in internal / third party auditing and global GLP / GMP / GCP quality system development and management. His professional experience covers biologically derived molecules, small molecules and vaccines, with companies varying in size from start-up and CMO based organisations to traditional “Big Pharma” with multi-Billion dollar responsibilities.  For relaxation Martin likes nothing more than walking his Airedale terriers in the local woods or watching them swim in the river.

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