GxP Lifeline Feature Article

The Big Leap into Automation: Do’s and Don’ts in System Evaluation
By Jim Murrin

How Life Science Companies Can Avoid Pitfalls in System Evaluation

The FDA is decidedly moving toward an electronic environment. Late last year, the agency solicited comments on its continuing effort to transform all regulatory submissions from paper to electronic and its plan to create an electronic platform that would facilitate the exchange of drug safety and other important clinical research information.

If you work in the life science industry, there is probably no way to avoid automation in the long run. Not only is FDA policy pointing toward that direction, the cutthroat global competition is also likely to necessitate automation. Now more than ever, companies need to innovate, accelerate product development, and reduce costs. In all three aspects, automation offers advantages far beyond what a paper system (or a partially electronic system, for that matter) could offer.

Let’s say that your organization has contemplated all this, and finally decided to take the big leap into automation. If you’re part of the selection committee, how do you go about evaluating different systems?

Unfortunately, 70 percent of the time, system evaluations are not completed for a variety of reasons: the company falls on economic hard times, the budget is snatched away by competing projects, selection team members are reassigned or leave the company, there’s no management commitment, and the evaluation process itself is flawed. Considering these pitfalls, here are some do’s and don’ts to increase your chance of success in system evaluation.

Do Make a List of Your System Needs. Often called a User Requirement Specification (URS), it should define your project goals (the pains to be resolved or gains to be attained), identify and prioritize desired functionality, and list criteria by which you will evaluate competing systems. Make sure the list includes input from all those who will be affected, including management. The URS allows you to build consensus within your team, clarify your ultimate goal, and provide guidance to both the selection committee and the vendors throughout the evaluation process. 

Do Create an Evaluation Plan. Just like it’s hard to drive from New York to Los Angeles without a map, it would be equally difficult to evaluate software without first mapping out the steps you would like to follow. The system evaluation plan may include the following: creating a “Request for Information” document, reviewing demonstrations, testing a pre-configured trial site, talking with the vendor’s customers, and presenting a justification to management. Add to the plan a timeline, working backward from a desired go-live date. While you may choose to deviate from the plan, if circumstances call for it, the combination of the evaluation plan and the URS will keep you from wandering aimlessly.  

Do Establish a Justification Early On.  Even though you have a budget allocation, management will demand a justification prior to any investment. The benefits of a new system must be substantial to warrant such an investment. Work with management in making a financial analysis that would show the amount of investment needed to address your system needs. Involve management throughout the evaluation; if there’s a need to increase the budget you are proposing, you must be able to justify the adjustment.

Don’t Limit Your Evaluation to Features and Functions. The software solution you choose must fill the gap between the reality of an outdated paper-based or partially electronic system and your vision of an efficient automated system. Software doesn’t do this by itself. It is only after the system is up and running that you will begin to realize the solution’s benefits. So take a hard look at the vendor as much as the software. Can the vendor deliver project success? Does it have the domain expertise to understand and adjust the solution to your business? Does it have the resources to actually perform the nitty-gritty of implementation (and validation, if necessary)? The best way to answer these questions is by talking to the vendor’s current customers, looking at sample project plans, and visiting the vendor and assessing its processes first-hand. And, don’t forget to ask about a “money back” guarantee. 

Don’t Be Shortsighted. You should address your immediate needs, but you should also think long-term when it comes to the system’s usability and the needs of your company. Will the system be able to sustain growth (in terms of business operations and number of users)? Could you expand the usability of the system across the organization, if you need to? How much would the system cost over a five-year or a 10-year span? If the system needs to be validated per FDA requirements, how much would software validation cost (not only after installation, but with each upgrade)? Is the system robust to handle future regulatory requirements?

These are but a few of the many considerations critical in system evaluation. In the end, you want a system that will meet your business and compliance needs, but also offer maximum profit in terms of efficiency, productivity, and cost savings year after year.

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.

Read more about the benefits of automation of quality processes:

White Paper:
Automating Document Control Processes

White Paper:
Automating Training Control Processes

White Paper:
Automating Electronic Engineering Change

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