Sentry BioPharma Services admits one of the most exciting and frustrating aspects of information technology is the speed with which change occurs. New hardware and software products emerge with attractive features that make it easier for users to perform their jobs.
This becomes even more challenging when upgrade activities must comply with GAMP5 and 21 CFR Part 11 for GMP systems. The pharmaceutical and biotechnology industries mandate change control and software validation to prove control, avoid a breach and maintain data integrity. This is a very intentional process.
Information technology comprises:
- Client software
- Computer systems
- Network devices (routers, switches, network printers)
- Network infrastructure (cabling, internet connection)
- Peripherals (monitors, scanners, local printers)
- Security devices (firewalls, biometric and smart card readers, IDS appliances)
- Server hardware
- Server software
- Software packages
In 2012, Sentry BioPharma Services planned a multi-year technology upgrade program which commenced with an upgrade of user’s work stations, business servers and moved into upgrading the company’s non-GMP enterprise resource planning (ERP) system to optimize efficiencies. In the past two years, Sentry successfully upgraded and validated the building management system (BMS).
“Sentry’s information technology program is important to all of our pharmaceutical and biotech clients,” says Jennifer Marcum, CEO. She continues, “The U.S. Department of Homeland Security (DHS) warns of sophisticated cyber attackers and nation-states planning to exploit vulnerabilities to steal information and corrupt systems. The ‘bad guys’ are developing capabilities to disrupt, destroy, or threaten the delivery of essential services globally. We must be vigilant in maintaining awareness and managing the risks to thwart their plans whenever possible.”
Sentry’s technology upgrade program even includes upgrading the company’s website with mobile-friendly enhancements designed to improve prospective and existing client’s Web experience. The new website “Go Live” date is presently scheduled for the end of March, 2016.