ZenQMS Blog

With travel bans and stay-at-home orders in place throughout the US and many other countries, life sciences companies are struggling to maintain GxP compliance under increasingly challenging circumstances. Employees are working remotely- and so are FDA inspectors and auditors. And new regulations are being rolled out frequently in hopes of expediting the drugs, devices, and vaccines supporting the treatment and prevention of COVID-19.  

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. 

A message to our community of customers and partners:

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. 

Karin Ashkenazi has more than 15 years of experience in the life sciences industry, including experience as a quality leader for clinical laboratories. Prior to joining ZenQMS last year to lead the Quality team, Karin worked in a laboratory with a paper-based quality management system (QMS). They were a small organization with a limited budget and so they initially felt that a paper-based system was their only option. 

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. 

Background

This U.S. based contract research organization (CRO),  was founded in the early 1980’s and has been committed to cancer research ever since. Quality is at the core of their business model given that their clients are life sciences companies and subject to regulatory compliance and good manufacturing practices (GMP.)  The company is audited multiple times each year by their clients and could be audited by the FDA at any time so it is critical that their Quality Management System is best-in-class. 

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.