There are many things that should be considered when selecting an enterprise system for monitoring GMP storage areas. Among these concerns are:
In this blog, I will focus on the third item: validation.
The ISPE created a convenient framework in their guide GAMP: Good Automated Manufacturing Practice
so let’s use that framework here. First, and in alignment with the GAMP guidance, we separate our possible monitoring systems into three categories based on the GAMP Guidelines.
a) Off-the-Shelf (GAMP Category 3)
b) Configured (GAMP Category 4)
c) Custom (GAMP Category 5)
If we break down the validation costs and efforts associated with each type of system and rate them on a scale of 1 to 25, we get a simplified view of the validation as seen in the matrix below. On that scale, nothing has less than a 5 - this is to recognize the fact that they all require effort. Even the simplest system installed in a GxP environment is going to require validation that includes, at a minimum, the following documents:
Using the GAMP categories, this table shows the difficulty of validating each type of system:
Remember that choosing a monitoring system is more complex than just comparing levels of expected validation effort. While an Off-the-Shelf system may be relatively simple to validate, it will come with the compromise that the system will likely not be very flexible and only have limited capabilities. Similarly, a Custom system will take a significant effort to validate, but will likely yield a higher level of capability. Many people take the middle road of the Configurable System, for the comfortable compromise of a moderate validation effort coupled with the flexibility of a configurable system.
Evaluating the validation effort and cost is only one element of making the right choice. If your organization has limited validation experience, capability, or budget, you should include ease of validation in your User Requirements document. This will help guide you to systems that require less validation, or to vendors that offer validation services. Organizations in this group will likely select Off-the-Shelf or Configurable systems. Organizations with experienced and capable validation group are more likely to opt for greater system flexibility and greater validation effort and select Configurable or Custom systems.
I'm happy to discuss your validation projects with you.
Paul Daniel is the Senior GxP Regulatory Expert at Vaisala. He has worked in the GMP-regulated industries for over 20 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems. At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.