It simply makes sense for drug manufacturers to invest in technology to monitor labs, chambers, cleanrooms, warehouses, and other critical spaces in their facilities. But with no shortage of suppliers offering systems for tracking temperature, humidity and other key parameters, how do you know where to turn and who to trust? Which technologies and environmental monitoring systems (EMS) will meet your business and quality needs now and well into the future?
Fig. 1. A correctly sourced environmental monitoring system (EMS) provides the proper balance between quality, compliance and cost.
This article outlines an approach for sourcing an effective real-time environmental monitoring solution—one that will meet your requirements near- and long-term. By asking the right questions and collecting the right information, you can evaluate whether a solution will fit your purposes. Having a full scope of knowledge will save you time and, most importantly, bring high return from your investment.
Where to Start: Who Are Your Constituents?
Start with a systematic approach that targets your priorities for meeting business, quality, and regulatory requirements. Begin by seeking council from throughout your organization.
Chances are the solution will involve multiple responsibilities across your company, including quality assurance, facilities engineering, IT, operations, metrology, and purchasing. Including them in your project team from the start has several benefits. First, the decision to purchase a system will affect these various operational functions at some point, and early involvement can turn colleagues into supporters or at least non-dissenters. And it can help avoid problems down the road. Asking IT about network compatibility in the middle of your search, for example, can delay progress or even kill the project.
Second, anyone installing, using, maintaining or signing off on a capital investment will likely have set requirements or preferences that can influence the direction of a search. With each constituent, reach an understanding of basic requirements and current challenges. Document their expressions of wants and needs and how a solution could help get the job done more effectively.
Define the Project
Using data gathered from all parties, categorize requirements based on the risk to the business and product quality as specified by the Quality Management System. The result should contain a set of minimum requirements and a group of others relative to their importance to the company and various departments.
Once this is done, needs can be coalesced into a defined project. State the rationale for replacing or adding a new system and, where possible, refrain from specifying how to meet stated challenges. Systems will vary in their technology approaches and you want the flexibility to consider alternatives.
Develop a User Requirements Specification (URS)
While writing a User Requirement Specification is beyond the scope of this article, there are a few basic concepts to keep in mind. A URS should contain agreed-upon elements that will provide a consistent reference for vendors. It will document what you need the system to do. The project scope should have boundaries on the size of the facility, campus, or locations you want to monitor. The URS also needs to state the monitored environments such as warehouses, freezers, water quality systems and measured parameters such as temperature, humidity, pH, and conductivity. A supplier’s approach may vary on the number of sensors, types of parameters and their locations.
Clearly state your requirements. In fact, use the language of the FDA when something is required—it ”must” or “shall” have (fill in the blank). Try to leave little room for ambiguity. Later, the vendor can express ideas that you may not have considered, but the URS should at least bring readers to a similar interpretation of what you are asking.
What Questions Should You Ask?
The evaluation process often works in stages, especially when there is insufficient information to distribute a request for proposal (RFP). To assist this process you can send a request for information (RFI) to multiple suppliers. The questions below can serve as a template for an RFI, with the results feeding your RFP. Beyond the URS, your evaluation has to consider the strength of business partner supplying and supporting the environmental monitoring system. Ask open-ended questions to draw out how the supplier thinks and obtain ideas for addressing your challenges. Let’s review some questions.
I. Questions about the Supplier’s Business
Equally critical to system capabilities is to understand the strength of a company in terms of their expertise, innovation and support. All three are important because you are likely making an investment decision that will span 10 years or more. A company with application or system experts that has little capability to innovate, for example, may leave you with a system that needs replacement before you expected.
- How long has your company supplied environmental monitoring systems to GxP facilities? If it is a new entrant to the market, you want to know it. On the other hand, a lengthy history does not necessarily equate to quality, but these companies have learned a few things from their customers and have demonstrated staying power.
- How many of these systems have been installed to date and what percentage is GxP regulated installations?
- Who are three customers in related organizations that can be contacted for evaluation purposes? At a minimum, this lets you know that they have reference sites to visit and their proximity to you if you need to make the trip.
- How does your company rate itself in terms of customer support? This question tells you whether a supplier has a process for measuring customer satisfaction and incorporates feedback to improve its organization.