Computer system validation (CSV) plays a critical role in any GxP system implementation. Whether you are developing a manufacturing facility or setting up a quality management system (QMS), you are not immune to the rigors of the CSV process. Let’s explore five CSV challenges that commonly impact technology and its implementation.
Years ago, in my first consultative journey, I assisted a therapeutics company in Research Triangle Park (RTP) by bringing a cGmP manufacturing facility online. Initially, I was hired to assist with the data center and network engineering. However, I was quickly pulled into working with a premier laboratory information management system (LIMS) provider to implement a brand-new platform for the facility. The challenge? Validating the 32 laboratory jump-points each bench scientist was required to access remotely in order to utilize the system. Whereas six weeks was more than enough time to complete the project’s original scope, at this point six weeks became a stretch goal. Compound this time crunch with construction delays, facilities’ needs, and the most humanized concern of all—people working overtime—and you can see the dilemma.
Growth-stage organizations are focused on rapid scientific innovation, enabling them to move quickly. Whether they are a bioanalytical team supporting cGmP analytical operations or a manufacturing technician team producing clinical trial material, every day or even hour saved is critical. Maybe the teams have a critical need for electronic notebooks or to upgrade their existing platform. If both functions do not align, multiple systems appear, SOP overlap occurs, system integration is near impossible, and system nomenclature is lost. Standardization loss on day one makes achieving organizational standards set fourth by ISPE even more difficult and time-consuming to meet once organizations hit their late stages.
It’s easy to talk about the FDA’s current and dated guidance and how it can hamper technology. However, I want to spend some time talking about the lack of platform integration. Some laboratories may need an informatics system from Agilent, while others may need a data management platform from Thermo Fisher. Early on, organizations should consider data integrity when adopting a new line of business applications. Keeping data in silos is one of the biggest productivity hampers and leads to increased operational costs across any organization.
Anyone who joins a rapidly-growing organization knows (or will quickly learn) you must be scrappy, meaning you have to work quickly and accept that you may need to change course at a moment's notice. This requirement is no different in the life sciences industry. In fact, operating speed is accelerated by scientists who are excited about the next innovation and organizations that are dedicated to patients. This combination can create a tunnel focus on any CSV activity’s scientific components, at the expense of the operational components. Often, I have concluded a manufacturing project feeling like another information technology (IT) implementation specialist or a facility-focused project manager would have enabled us to save time or avoid obstacles that created a lot of busywork.
It takes a tribe to get any 21 CFR.11 complaint system onboarded successfully. In a prior life, a project for a validated contracts management system required a revolving door of vendors, SMEs from many departments, and what felt like my entire tenure to conclude. Another time, a manufacturing facility project was delayed due to scheduling alignment challenges between two vendors. Availability is not only a concern during system implementation; it’s also a consideration during maintenance.
“The day the CSV model is replaced with something like computer software assurance is the day we’ll see massive strides in solving a lot of these problems.”
Regular testing and balancing of your cleanrooms and electronic monitoring sensor calibrations, as well as IT infrastructure maintenance, takes heavy coordination, typically during holidays and well in advance (six months at least). Computer system validation is a challenge that’s not going away anytime soon. Our Pharmers are always plugged into the industry experts and their take on how industry guidance is adopting modernized technology. The day the CSV model is replaced with something like computer software assurance is the day we’ll see massive strides in solving a lot of these problems.
Regardless of the issues your organization may be facing, PharmHand has been purpose-built to lend informed hands and ensure your technology barriers are as transparent as possible.