Introduction
Many life sciences customers require their ServiceNow deployment to meet GxP (Good Practice) requirements, such as 21 CFR Part 11. For example, if the ServiceNow module impacts manufacturing processes or handles protected health information (PHI), it needs to be validated. Regression testing of GxP modules requires extra steps. Many ServiceNow customers have asked how they can best manage validation testing. In this article, we share some insights on achieving the unicorn of cheap, fast, and good in GxP validation and testing.
Good, Fast, Cheap
The project management triangle is an excellent way to frame this discussion:
People, Processes, and Technology
The project management triangle consisting of people, processes, and technology applies to GxP validation and testing in ServiceNow. However, achieving cheap, fast, and good in GxP validation and testing is challenging. There are usually trade-offs between quality, cost, and speed. A balance must be struck between these three variables, and the best approach varies depending on the company's circumstances.
People
Many ServiceNow customers outsource the RUN of their ServiceNow instance, including deployment, enhancement, and upgrades, to a System Integrator (SI). However, fast and good SIs are rarely cheap, which has prompted leadership to explore other options. While cheap and good SIs exist, they are slow, and they may not meet the business needs fast enough. Companies must find the right SI partner that works for them. One way to do that is by using ServiceNow's Partner Finder.
Process
Working with compliance is usually a negotiation process, and the compliance team will always seek the most restrictive options. It is important to communicate which requirements have significant investment costs and see what alternatives may work. Some companies have had success using Traceability Matrices per release (available in CORE, Join KB) as a starting point to minimize regression testing with out-of-the-box capabilities. USDM and Quality Forward are two vendors that can help structure the proper validation process and negotiate with the compliance team.
Technology
Several technology options are available for GxP validation and testing. The Automated Testing Framework (ATF) or Selenium are fast and cheap (free for ATF) but may not satisfy all regulatory and compliance requirements, such as URLs, timestamps, and exported documents. ServiceNow acquired DotWalk to assist with upgrades, where its Machine Learning engine can create the ATF flows automatically, but these may not follow the same flow that needs to be validated. AutomatePro is an excellent partner software solution that can help with time optimization and proper document generation.
Another technology route to consider is to use Quality Forward's eQMS or USDM's ProcessX "platform" within ServiceNow to stand up GxP-specific processes. These are validated and secured store apps, eliminating the need for extensive validation testing for these processes as the vendor takes that on. This approach also provides an opportunity for application consolidation for ServiceNow customers.
Customer Journeys
I would like to share a few brief anecdotes about our customers' experiences. It's important to note that these journeys are ongoing and constantly evolving, so we encourage you to share your own experiences in the comments section below.
- One of our larger pharmaceutical clients outsourced their consulting and testing needs to Selenium, and they paid a premium for the all-in-one services, including accepting a two-week shutdown per upgrade policy.
- Another large pharma client opted for a lower-cost option with a G4 SI, which proved to be adequate but not efficient. Eventually, they found a balance by partnering with AutomatePro for run support, resulting in quick and automated testing, comprehensive documentation, and smoother upgrades and migrations. Though the cost rose, the value was worth it for this pharma company looking to streamline their processes.
- Another large pharma company is currently undergoing a complete automation journey to bridge the gap between agility and regulatory requirements. While they currently use ATF for quality assurance, they have found that it's not quite enough for their needs and are exploring other testing technologies.
- A mid-size pharma company chose to outsource their regression testing to a national SI but found the extensive testing to be overly complicated for simple releases. They are now seeking consulting support from a partner with a computer systems validation background to formalize their process.
- Another mid-size pharma company leveraged ProcessX to modernize their previously paper-based Audit findings, CAPAs, and Deviation/Non-conformance Management. Those modules are all validated by ProcessX so they can focus their limited staff to validation testing incidents and changes.
- Finally, some smaller pharma companies forego GxP altogether due to resource constraints. In these cases, GxP processes, like change management, is tracked in a separate antiquated, but validated, system.
Next Steps
There are no one-size-fits-all solutions. Every customer is unique. Please reach out to your account team and, in particular, our customer success organization, and they can help start or continue the journey with you. Please share your stories, insights, and technologies in the replies below!
