A holistic approach to safeguarding quality data
Neal Salerno, President, Eurofins Lancaster Laboratories
As guardians of our clients’ testing data, there is a considerable responsibility for each of us to ensure quality, efficacy, and safety with all biopharmaceutical and medical device products brought to market. As we strive to achieve absolute quality, we will always raise the bar and look for better ways to serve our clients. Embracing this spirit of continual process improvement, we hold a firm commitment to drive quality and LEAN initiatives to surpass client expectations. There, however, is not a magic wand to wave as delivering impeccable testing services and quality data has many moving parts and requires a holistic management of all contributing facets.
During the past five decades, we’ve built an outstanding reputation for our quality program, ensuring our processes and data meet clients’ goals and global regulatory compliance requirements. Through continuous improvement of our rigorous quality systems review and trending of lab performance, internal lab audits, submission of system suitability samples and review of lab data, we take many steps to reach our quality metrics standards.
For example, we’ve implemented a Quality Assurance Reorganization to foster an improved alignment among QA, testing labs, and Validation and Data Security groups. Specialized teams focus on biologics, small molecule, medical device, as well as audits, metrics and compliance. Further, our new Integrated Quality Assurance initiative, incorporates a QA staff floor presence in each laboratory. This daily quality presence enables analysts’ questions to be addressed real-time while allowing the QA staff to perform routine internal audits of our facilities to ensure we are operating in compliance with regulatory guidelines,client protocols, and our quality program.
Additionally, we’ve established Key Quality Representatives, serving as strategic liaisons to help clients streamline their outsourcing experience through a myriad of service solutions such as, continuously monitoring an account status, overseeing investigations through to closure and compliance as well as trending of errors and corrections, process improvements, metrics and score cards, for example. Representatives are required to conduct routine client briefings/follow-ups regarding an investigation status and ensure projects flow smoothly.
Giving clients the peace of mind that their data is not only accurate but secure is where our Electronic Systems & Data Integrity Team’s role is essential. While our Data Integrity Council scrutinizes instrument integrity, including an extensive instrument, qualification, calibration and maintenance program, much weight is placed on our ethics and documentation training for our people. We create a quality driven culture for our staff, recognizing that not every system can detect an error, and therefore investing in the human element has significant value.
To that, our Training Investment is a multi-front methodology that prepares staff to catch mistakes before they happen. Our intensive and comprehensive training programs target core skill sets with dedicated training resources for all pertinent processes within the lab. Enhanced documentation training is geared specifically to an individual’s testing in each department. We enforce a strict Quality and Ethics Policy signed by all employees. Compliance with cGMPs and GLPs include training for all new employees and annual refresher courses for all employees. Ongoing training includes monitoring changes to regulatory requirements that impact the various aspects of our business to ensure our compliance with all current regulations. We’ve developed a Root Cause Analysis Training for everyone performing investigations to determine the root cause of error. Finally we’ve begun certifying technical investigation writers which qualifies select analysts to submit thorough investigations.
Navigating regulatory waters in the US and EU is a complex and sometimes daunting task of the drug development process, and our Regulatory Affairs Team delivers a compliance review and consulting lifeline. This team can support clients with regulatory filings and guide them through the critical regulatory decisions on their programs.
From rigorous employee training to intense quality systems scrutiny, I hope it is evident that we will never give up trying to improve our quality initiatives and will always look for ways to get better at serving our clients.