XaaS Data Integrity Gurus Draw Chapter Members to WPI

As technological advances increase, the need for companies to comply with robust data integrity practices becomes more and more important.  Chapter members gathered at WPI on April 12 for an educational program on data integrity which took place in conjunction with the Student Poster Competition. As a special bonus, attendees were able to view the posters and mingle with students during the networking reception.

Chapter President Jack Campion kicked off the program by welcoming attendees and describing important upcoming events, including a week of training hosted by the international ISPE organization, right here in Boston!  He then introduced presenters Heather Longden (Senior Marketing Manager, Waters) and Kosal Keo (CEO, Boston Technology Research) – representing a software vendor and industry consultant, respectively – who would cover the importance of data integrity measures including Computer System Validation (CSV), managing vendor relationships, and the roles and responsibilities of operating companies and vendors using the as-a-service (XaaS) applications.

Data integrity is essential to the industry, helping to save/enrich patients’ lives and prevent costly fines, shutdown of production and issuance of 483s by the FDA.  It is important to maintain good data integrity throughout the entire lifecycle of software programs and should even be considered prior to choosing the software vendors.  Ultimately, data integrity is the responsibility of the individual operating company and (other than Software-as-a-Service models) the software vendor can be seen as a partner in achieving good data integrity practices.

The first speaker was Heather, whose presentation focused on leveraging vendors to support data integrity initiatives.  She began by explaining how data integrity has evolved over the years, and how software vendors can assist with data integrity by ensuring that applications are robust and “tamper-proof.”  She stressed that operating companies should verify that the vendor and software they are considering meet all of the appropriate requirements, including compliance with regulations such as 21 CFR Part 11.  While there are a lot of regulations, there are also many organizations that can provide assistance, such as ISPE and the WHO.

Heather cautioned operating companies not to put their software suppliers “on the hook” during an FDA audit and to be clear about requirements prior to the audit.  While vendors can assist with compliance, they are not completely familiar with company SOPs, training logs, etc. Furthermore, relying too heavily on vendors during an audit can make it appear that the operating company is not up to speed on the necessary details. Companies should prepare for audits well in advance, developing good answers for the many potential questions auditors may ask to help avoid any pain points.

 

Following Heather, Kosal Keo took the floor with a presentation on the XaaS (software, platform, infrastructure as-a-service) cloud service models.   The technological advances of cloud computing technologies have somewhat shifted the roles and responsibilities of operating companies being audited, as well as software vendors supplying the technology.  Kosal focused on providing a governance model on XaaS and setting up specific policies and procedures from an IT-compliance perspective. Despite the shift in roles and responsibilities, the operating company is ultimately accountable for audits and for qualifying that software vendors meet the company’s minimum compliance standards.

All in all, this was a great educational program with knowledgeable and passionate speakers who brought their incredible energy to the stage.  The event also brought together professionals with a variety of roles in the industry: Validation Engineers, Quality and Compliance professionals, IT professionals, software suppliers and others who are influencers/decision makers with respect to purchasing and maintaining software applications for their companies.

Program managers Robert Wherry and Christopher Ciampa would like to offer special thanks to Commissioning Agents for their generous sponsorship and WPI for hosting the event and providing the wonderful spread of food available during the networking reception.