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.
Whether it’s your first or fifth or five hundredth audit, you can never be too prepared. We recently hosted a webinar on exactly this topic, hosted by quality and systems expert Ed Morris. Morris walked through tips for preparation for and day of your audit.
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.
Regulated industries, life sciences in particular, have experienced significant changes in the regulatory environment in the past decade. The standards themselves haven’t really changed very much at all- whether it’s ISO 9001 which is focused on quality management, ISO 13485 which is focused on medical device quality management, or the technical standards such as ISO 27001. What has changed over the past 10 years is that the businesses responsible for implementing and maintaining the above standards are increasingly aware that not everyone can apply the same priority to all of the controls. The result is an increased focus on risk-based methodologies.
Why pursue ISO?
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.
Intelligent Quality is an approach that is rooted in the digital transformation that we’ve seen across all lines of business over the past decade or so. The complex, modern organization has tools available in their ‘back office’ that offer data analytics and valuable insights to company leaders- enabling them to make informed decisions about their business strategy. We have seen the explosion of growth and advancement in CRM and ERP, for example, and there is no reason for quality and compliance teams to continue to use stone- age tools.