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    Audits are like the city bus: sometimes you wait forever for one to come around. Other times, they show up in quick succession, back to back to back. 

    No matter how often you encounter an audit or the type of audit (internal, external, or from regulators) it’s critical to be ready for them. This “always on” mentality can be overwhelming and stressful, but there are specific best practices and procedures life science organizations can implement to take a proactive approach to audit readiness. 


    Common audit pitfalls

    What can go wrong during an audit, or where can organizations struggle?

    You can’t find documents

    If you can’t find a certain cohort of documents (such as those approved within a certain time frame) this immediately demonstrates that things aren’t as organized as they should be. This also indicates to the auditor to probe more to uncover additional challenges in this area. 

    You view auditors as adversaries

    Treat auditors as part of the team, instead of working against them. Auditors are the industry’s ally in upholding industry standards. It’s important that life science organization’s processes are upheld to ensure the integrity and safety of healthcare products. 

    Decisions aren’t recorded

    Auditors may ask about a specific decision made about a brand or business process. If these decisions aren’t captured (either because the decision was made a while ago or team turnover), this can cause issues and once again, demonstrate disorganization. 

    Best practices for audit preparedness

    How can you make sure your team is always ready for an audit, no matter what? 

    Have the right mindset

    You never know when an audit is going to arrive, so behave as if one could show up at any time. Operate under the assumption that an audit will show up so that you’re not caught off guard when it does. 

    Set up “nerve centers”

    For more critical audits, convene the audit team in a single room. The focus of this “nerve center” is to help the audit run smoothly. The team can manage the process, respond to inquiries, find documents and decisions, and contain the audit response staff to a single location. 

    Undertake training

    There are behaviors that need to be drilled into the team in advance of an audit. For example, answer only what is asked during an audit (after clarifying the question being asked!). Some of these behaviors require both training and practice to get right. 

    Lean on software

    Software designed for promotional review can not only keep record of all documents, but can also be an excellent decision making log. By capturing this information electronically, you not only make it easier to find the information you need during an audit but also results in less team time and resources needed for an audit response.

    Tag(s): Compliance

    Joe DiCapite

    Head of Strategy for UK/Europe

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