Five Things to Expect from a Compliance Software Vendor - GxP Lifeline

Get the Most Out of a Compliance Software Purchase

The advent of JetBlue's Customer Bill of Rights has increased public awareness about the consumer's fundamental right to get his or her money's worth. Whether you're buying an airline ticket or a car, you should know what you can expect from the seller.
Let's apply this concept to life science companies purchasing software for managing the content derived from their GxP processes. In the February issue of this newsletter, we discussed the things that a life science end user should consider, namely:

  • Does the application answer the end user's needs?
  • Does the vendor have the domain expertise, adequate technical and financial resources, and philosophy to deliver a successful solution?
  • Are the end user's evolving needs and the vendor's long-term development plans aligned such that the partnership will endure?

I recently had the privilege of visiting several life science customers to ask them what they expect from us as a solution supplier. They were surprised that a vendor would ask such a question. The fact that a vendor would adjust its programs to maximize the customer's return on investment was novel to them.The following are some of the insights I gained from my recent visit with customers. While this is not exactly a bill of rights, it should give you an idea of how to get the most out of your software purchase.

1. Your Vendor Should Treat You as a Partner. Customers don't buy software. They invest in a solution that bridges the gap between current pains and future gains. And like a bridge, a successful compliance software solution is the merging of technology, the vendor's domain expertise and deployment capability, and the customer's User Requirements Specification. For life science companies, projects are made even more costly and time consuming due to software validation requirements. Pick a vendor who views you as a partner, and who can support your needs both during and after deployment. The vendor's support policies should be sensitive to your change-control and upgrade restrictions, particularly as they are influenced by FDA expectations. Throughout the solution's lifetime, the vendor should explore with you how to continually maximize your investment by leveraging existing or future functionality to make it more efficient and to solve additional problems.

2. Ask About a Money-Back Guarantee and Product Swaps. At decision time, you take a risk that a compliance software application will actually solve your problem. Unfortunately, it is virtually impossible to completely mitigate this risk, since not every feature can be tested in the exact configuration, including hardware and usage patterns. It is entirely possible that you will go through the rigors of software implementation and user training before realizing that the solution is not what you thought it was. This would mean a financial loss, a waste of time, and maybe an increased risk of noncompliance. To ease your mind and lower your risk, ask about the ability to swap products as needed to ensure project success. In a worst-case scenario (if the solution can't be attained), ask about a money-back guarantee. A trusted partner would want you to maximize your return on investment while minimizing your risk of failure.

3. Guide Ongoing Product Development. Paying a maintenance and support fee should serve as a guarantee that you have some say over the software's ongoing development. This is a win-win scenario; the customers protect their investment by driving functionality beneficial to them, while the vendor gains a more mature and differentiable product that can be marketed to other end users. Sometimes product influence comes through ad-hoc communication with the vendor, and other times it occurs through a representative industry/product advisory group. Find out if there is a formal mechanism to input enhancements, assist in prioritizing them, and track their progress.

4. Take Advantage of Ongoing Education. Most end users utilize only 10 percent of a compliance software application's capability. Partly this is because it is all they can absorb at any one time, and partly because it is enough to satisfy their immediate requirements. Unfortunately, this might exclude functionality that would make the application more efficient and easier to use, especially as the customer's needs evolve. A trusted partner will offer structured courses to address both beginning and advanced subjects, and allow customers to retake as needed without additional charge in order to ensure complete understanding. Recognizing that the best education often comes from other customers with similar deployments, the vendor should organize either user groups or online forums where customers learn from one another.

5. Ensure Adequate Technical and Commercial Support. At some point a problem with compliance software occurs that falls outside standard training programs. Customers should be able to lodge concerns with the vendor and receive prompt and priority-based response. Verify that a vendor has policies and resources to address these problems. Some problems are not immediately solvable, so it's important that there is a means for tracking them. Above all, make sure that the vendor is committed to your success, so that fixing the problem is a primary concern.With these five things in mind, you can approach the task of automating and optimizing your processes better and also heed the FDA's call for increased modernization of operations more readily.

About the Author
Jim Murrin, senior vice president of sales for MasterControl Inc., is an engineer with more than 20 years of technology sales experience.

Other complimentary information for life science companies:


FDA Link

  • FDA Guidance Encouraging Adoption of Modern Technologies (Quality Systems Approach to Pharmaceutical CGMP)
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