“Transform audit fears into opportunities with strategic preparation. Learn how meticulous planning and a positive mindset can lead to successful life science regulatory audits.”
Find out how with ample prep you can turn your fears of audits into opportunities to highlight just why your processes are top notch.
Regulatory compliance is not simply another checkbox item in the life science industry. It underpins innovation and ensures patient safety so that products can be available on market quickly and safely etc.
It is a daunting challenge to weave through the quagmire of regulations, directives and quality benchmarks. That said, the audit process is where life science companies must put their efforts in terms of quality and regulatory compliance.
Pre-audit challenges:
Life science organizations are well understood at BioBoston Consulting. This is where the art of audit preparation comes in and why it can be critical to success when your regulators come knocking.
Life Sciences: The Audit Landscape
The role of regulatory audits is to ensure quality and safety in healthcare for pharmaceutical, biotech companies or medical device manufacturers. These are inspections by health authorities (FDA, EMA etc) to create a report which contains an assessment on the level of compliance of that particular company with respect to guidelines and regulations. The results of these audits can have a wide range effect to the company-product registrations, market entry and in some cases reputation.
The High Stakes of Audits
Non-compliance has dire consequences in the life science industry such as reporting on recalls, fines to be paid by a company or damage done to reputation and the worst case becoming inoperative. This is why it is important to treat this process with the necessary rigour.
Shifting Audits from a Boring Job to an Exciting Opportunity
So, what can you do to help ensure that your audit is successful beyond program compliance? Well, it actually begins with a change in mindset. So instead of an audit being seen as a terrifying experience, it should be taken as a means to showcase just how dedicated life science companies are in terms of the quality and meeting regulatory requirements. This shift in thinking is the beginning of a winning audit.
How Meticulous Planning Helps
Planning is the key to audit achievement. This is a structured and exhaustive way to check that everything you are doing complies with the appropriate regulations or quality norms, including all your operational processes. This is how detailed preparation can change things:
Assessment of The Present Practices
You cannot fix compliance gaps until you know what they are. There go through a comprehensive review of your existing practices, systems and documentations to identify any possible gaps when compared against the regulations. With that said, the next thing you need is an assessment of what skills/capitals/advantages will give you a higher likelihood (note it is not guarantee) to succeed in venture. This should be done as objectively and rationally as possible.
Adherence to the Legal Standards
If there are gaps, the next step is to prepare your organization for regulatory requirements. This could mean updating standard operating procedures (SOPs), revamping quality management systems, or adopting new processes or technologies to comply with today’s standards.
Documentation and Documentation
In the world of Life Sciences, it is as close to a Golden Rule you will find: If it is not documented, then it did not happen. Documentation ofOperations from research and development through manufacturing to distribution includes keeping accurate records of equipment maintenance, training and adverse reactions.
Staff Training and Awareness
Your employees are your first line of defense against noncompliance. Continued training and awareness programs can be used to make sure everyone in the organization knows their part when it comes quality and regulatory standards.
Mock Audits
Practice mock audits: Mock audits form as an integral part of the training process. These exercises mimic everything that comes with regulatory inspections but gives your team a taste while discovering points of noncompliance they missed.
The Most Common Audit Issues
Data Integrity
The data integrity has become a buzz word these days. Now, regulators are ever more cautious about data accuracy and integrity especially within the realm of pharmaceuticals. To address this challenge:
Apply data integrity standards and policies.
Invest in securing data by technology solutions.
Create awareness and suggest data integrity best practices to employees.
Supplier Management
Manufacturers in the life science industry also need critical components that come from a network of suppliers as well. If you want to prepare for an audit, one of the most important things is verification that your suppliers adhere to good practices in relation to regulations. To reduce your supplier based risks –
Develop effective programs for supplier qualification and auditing.
Enforce appropriate supplier quality agreements to confirm the expectations.
The third solution is to monitor and audit critical suppliers on a frequent basis.
Evolving Regulations
Rules and Requirements in the life sciences are always changing. Remaining compliant in light of these changes is key.
To address this challenge:
Keep a regulatory intelligence program in place to stay abreast of changes and decipher new rules.
Consultation and feedback with the regulators
Educate and Train your team about the most recent regulatory updates
The Audit Day: Displaying Compliance Leadership
Then the day of your audit rolls around and you are put to the test with everything prepared meticulously. How to show how great you are at compliance
Be honest: Do not lie to the auditor. Promptly respond to Defense Contract Audit Agency (DCAA) requests for documents and information
Confidence: Show confidence in your processes, systems and team If an organization is well prepared, they are more likely to be able to successfully audit.
Communication: Tell your employees to engage well with auditors. Having a team approach to engage with auditors is something that they appreciate.
Continuous Improvement: Use the audit as an opportunity for continuous improvement. Assume the audit will come out just fine but find places where you can improve further.
Conclusion: Embracing Audit Readiness as a Strategic Advantage
For life sciences organizations, regulatory audits are a must. With careful preparation and a positive attitude, you can complete a successful audit.
BioBoston Consulting is used to the long, complicated process that goes into preparing for an audit and we can help you every step of the way. Because after all, a regulatory audit-ready organization is one that will not only adhere to regulations but can also succeed in a regulated industry where quality and compliance are intertwined.
Therefore, accept the readiness of audit as a strategic advantage and make it a success.
Visit our website to learn more about how BioBoston Consulting can accelerate your organization.
