Discover the three critical mistakes that 80% of businesses make during audits and inspections. Learn how to improve documentation, preparation, and communication for better compliance outcomes.
With the prevalence of a highly regulated business environment, compliance audits and inspections are becoming more frequent. Despite the efforts of companies to get prepared, 80% only make them worse which can result in catastrophic outcomes. This is important for those who belong to biotech consulting firms in Boston as well as even a life science consulting firm or pharma company. In this post, we discuss three common ways businesses go wrong during audits and inspections and how they can be avoided.
Inadequate Documentation
This is perhaps one of the biggest mistakes made — A lack of complete and accurate documentation. Auditors and Inspectors are swamped with paperwork that demonstrates a company’s adhering to regulatory standards. As the internet does not observe traditional hours of operations, failing to guarantee proper 24/7 remote access into incomplete or disorganized records could raise red flags and ultimately become non-compliance finding.
Why This Happens:
In many cases, the way we provision and configure infrastructure can influence security in ways developers may not understand. We often struggle because software engineers need to know why something matters before we can generate sustained change.Inadequate Training — It is common for facility personnel to receive training on compliance requirements that they either do not trust, understand or haven’t been taught to implement..
Systems Are Aging: Older and less efficient documentation systems can be harder to keep up with.
How to Avoid It:
Train your Staff: Provisions must be given to regular training for the staff on how to properly document and the protocols for compliance.
Use Solid Documentation Systems: Employ sophisticated documentation schemes that make files both convenient to access and periodically maintained.
Perform Internal audits: Consistent internal audits may help identify where documentation falls short before an external audit.
Lack of Preparation
Preparation is key when being audited or inspected. The reality is that most businessesrun around when audit notice arrives.
Why This Happens:
Business can be Complacent when they did not have any audit problems and everything just sailed through.
Over-confidence: This can be seen in companies who think their current ways of working are good enough and do not require continuous improvement.
Resource constrains: Limited resources may result in audits being prepared late or inadequately.
How to Avoid It:
Scheduled Mock Audits: Organize scheduled mock audits to gauge readiness and recognize vulnerabilities.
Continuous Improvement: In other words, a process to ensure that existing systems are periodically reviewed and improved upon.
Assign resources: Make sure to allocate necessary resources on audit preparation, even establish a dedicated compliance team if needed.
Poor Communication
Effective communication during an audit or inspection: Failure to communicate todifferent parties involved may lead to compliance issues due to misinterpretation or lack of communication.
Why This Happens:
Because the departments are siloed: The separate departments may not communicate with each other properly and this can cause compliance practice mismatches.
Roles are Not Defined: If employees do not understand the execution of their role during an audit, then it will result in confusion and errors.
Without a Single Point of Contact,you may sometimesget lost between all the information.
How to Avoid It:
Appoint a Compliance Officer: You should have one person who is compliance officer to manage and direct all audit activities and communications.
Promote Inter-Department Communication: Help drive day-to-day conversations between departments so that everyone is up to date on regulatory compliances.
Encrypted Communication: You can set up encrypted communication channels so that only the users who are supposed to have access will know they have it from a trusted source.
Conclusion
Inspections and audits are essential aspects of being within the jurisdictional limits of the regulatory rules and organizations, every organization should be taking proactive measures to avoid common mistakes. Companies that focus on improving documentation, adequate preparation and communication processes are likely to experience better audit outcomes. These components are essential for life science companies like Biotech, Pharmaceutical and Biopharma Firms to ensure compliance and operational excellence.
Get in touch with BioBoston Consulting or visit their website to find out how they can help you.
