As COVID-19 continues to spread across the globe, governments urge citizens to self-quarantine, and the U.S. economy faces an uncertain future, the life sciences industry is under more pressure than ever. Pharmaceutical and healthcare companies continue to work toward the development of a vaccine and therapies for the respiratory infection that was declared a pandemic by the World Health Organization last week. And the FDA is rolling out updated policies to streamline the path to an effective vaccine and protecting the public from fraudulent products.
What are the two inspectional focus areas of regulatory agencies? Vendor oversight and data integrity. And agencies expect companies to take a risk-based approach, making them both quite daunting tasks.
Auditing a vendor starts long before you actually step into their office to perform the audit. For example, one of the first things you should look for when selecting a vendor is how willing they are to offer customers access to their platform- that may include performing demos of their solution, providing a sandbox environment or free trial, and responding to questions/ inquiries.
Data integrity is at the heart of quality culture and everything we do in the life sciences industry. It is a term that is often used synonymously with regulatory compliance but they are not actually the same at all. Whether or not you are building- or intending to build- commercial products, the data you are generating will later inform commercial filings and applications that will add value for the business. And so that data- and the ability to defend that data all the way back to the source- is very important.
Sourav (Neil) Banerjee is a Quality Assurance Director with 21-year track record of protecting patient safety and data integrity, with experience in Big Pharma, CROs, and Software vendors. As Director of Quality, he led eQMS implementations from the ground up. Given Mr. Banerjee's deep experience in selecting and implementing eQMS solutions in the life sciences industry, we asked him to share some tips for those who are just getting started or in the midst of their purchasing decision.
An electronic Quality Management System (eQMS) is the key in today’s world for preventing quality issues that can have life or death consequences for patients. Companies with tremendous potential in the regulated pharmaceutical industry can fail badly if they do not implement the right eQMS. Yet organizations that easily implement automated systems for many other functions often do not have an adequate eQMS in place. This is usually because the need for an eQMS is not understood early enough.
Members of the Life Sciences Quality Leaders Forums met in Princeton, New Jersey to discuss the ins and outs of audit preparedness in the midst of an ever-changing regulatory environment. Ed Morris, President and CEO of The Morris Group, shared his expertise with the group, suggesting that the first step should be to thoroughly evaluate your organization’s Quality Management System (QMS) and identify any gaps.
John Mandy participated in thousands of audits during his 26-year tenure as a Quality Leader at Pfizer. Early on, Pfizer had thousands of GMP suppliers and CMOs located all over the world. In any given year, Mandy’s audit teams were executing over a thousand internal and external audits and assessments. But even he was surprised when he was helping a site prepare for a significant re-inspection and had a local QA lead proudly show him a validation qualification for a new paper shredder. That was just one of many times that he observed teams not taking a risk-based approach to systems validation.
The mission of the Quality Leaders Forum (QLF) is to exchange knowledge and build a community of the best quality leaders in the life sciences industry. We will learn from one another and confront the challenges associated with compliance today – and in the future.