A critical aspect of any cGMP activity is documentation. As the old saying goes, “If it wasn’t written down, it didn’t happen.” But even as so many forms of communication have become electronic, paper-based documentation systems are still common among pharmaceutical companies. The simplicity of paper-based systems is seemingly obvious: all you need is a printer and a pen (with indelible ink, of course). But control of released documents throughout multi-facility and multi-product operations can create logistical challenges and compliance issues surrounding pen-and-paper data entry can be frustrating and time-consuming.
In addition, after these documents are completed, further work is required to capture crucial information in a format accessible for future reference. Who wants to comb through pages and pages of validation or batch documents to find something months or even years after the fact? Electronic systems offer instantaneous release of new document revisions, the ability to control the format of data input, searchability and many other advantages.
In order to implement a paperless system that adds value to the process and is compliant with relevant regulations (including 21 CFR Part 11), it is important to understand what challenges exist and what tools are available to overcome them. We invite you to attend our program at Bristol-Myers Squibb in Devens, MA on February 15 to hear to two excellent speakers explore the benefits of implementing a paperless documentation system and describe the important lessons they learned along the way.
Nancy Poirier of Bristol-Myers Squibb will present the lessons learned since 2006 when the company embarked on its digital journey. The Devens facility started with digitized manufacturing and laboratory processes to increase efficiency, elevate the level of regulatory compliance, and achieve operational goals. Covering the spectrum from creation of a paperless vision to the knowledge gained from practical experience, the presentation will provide valuable information applicable to companies of all sizes.
Charlie Maher of Commissioning Agents will provide an in-depth case study of how an Electronic Validation Lifecycle Management (eVLM) system was employed to assist an emerging biotech firm design and validate a new manufacturing facility. The presentation will describe the goals that motivated the company to adopt a paperless validation system, compare the paperless and paper-based systems for each of the major steps in the validation process, and assess how the paperless system measured up against the company’s goals. It will wrap up by sharing lessons learned from companies that have adopted paperless validation systems and will provide a guide to help attendees assess if a paperless validation system would be a good fit for their company.
To register for this program, click here.