Choosing the correct software product to fit your organisation is a complex and costly process within any regulated environment. From initial requirement gathering to process mapping to validation of the software in its intended environment the journey from vendor selection to go-live can be quite arduous.

In this article, I will offer my top five tips which will hopefully help you make better decisions when choosing the correct software for your organisation.

1. Make Sure Your Decision Makers Have Experience

Your company has decided it needs a new document management system due to a recent restructure.

Who’s going to be involved in the decision making process?

If you do not choose the right team at this point there is a strong possibility that you’ll end up with a sub-standard product for your organisation.

It cannot be emphasized enough how important it is to have knowledgeable experienced people on this team so the correct product for your company is chosen.

Remember this decision is going to affect many people in the company so take your time to find the correct people for this team, if you don’t have the relevant people in-house then hire a good external consultant who knows the life science software industry.

If you have the following three people on your team you are on the right track:

• An experienced industry professional who is familiar with the various software vendors in the life sciences.
• An experienced quality representative who understands 21 CFR Part 11 and Annex 11.
• An experienced IT person who understands what infrastructure will be required.

If I have omitted any key personnel in this short list, please feel free to add your comments at the end of this article.

2. Take Time to Generate a Clear Requirements Document (URS)

Far too often, this aspect of the process is ignored and people rush into decisions based on very high-level business needs.

For example, you need a document management system (DMS) but what exactly does it need to do in order to satisfy your business needs?

It’s not enough to assume every vendor will have all of the functionality you need so it’s paramount that the correct people are involved in generating the User Requirement Specification document or URS.

Related: Learn how to create a top notch URS.

URS’s can take time to generate as many different departments may need to be consulted in the process, but this is the one document you need to have nailed down before you start the vendor selection process.

Here’s is a quick tip, if you approach a vendor and they don’t ask you for your URS that should raise alarms bells, you want to choose a vendor that will be willing to work with you on an ongoing basis – see them as compliance partners more than vendors.

Any reputable software vendor should ask you for your URS so they can address your requirements in a Functional Design Specification (FDS), this is a document they will return to you detailing what requirements they can meet and what requirements they can’t satisfy.

Don’t be fooled by vendors, who can satisfy every requirement, there are many other considerations to take on board for example is the software useable and intuitive, will it be scalable if we need to roll out globally?

3. Research Vendors and Choose Your Top Three

Before sending out your requirements document you must first research what vendors are actually suitable and have the product you need.

It’s amazing how little research goes into this aspect of the process. Don’t just rely on a Google search to find the appropriate vendors, what if the best vendor doesn’t actually rank well on Google?
The life sciences is actually a surprisingly small industry when it comes to software vendors so it really shouldn’t be that difficult to come up with a list of suitable vendors.

Reach out to other companies who have implemented similar solutions, learn from them and understand why they have chosen a particular vendor. Be careful though, don’t make any decisions on one person’s or one companies experience make sure you do sufficient research before streamlining your vendor list.

It’s not a hard and fast rule but you should at this point know what three vendors you want to evaluate. Remember evaluating each vendor if done correctly will take time so it’s important to have a manageable number going forward.

4. Review the Vendors Functional Design Specification (FDS) in Detail

At this point you have chosen your top three candidates and sent them all the same copy of your URS specification. This is a critical aspect of the process and should tell you a lot about each vendor.
At this point I would focus on two main aspects, how long it takes the vendor to return the FDS and how many requirements they can satisfy from your URS.

Personally if a vendor takes a long time to respond with this document it’s a telling sign, what happens when you have problems with the software when you need a critical patch because production is being held up…will they be slow to respond then?

The other one to look at for is the vendor who comes back with a FDS that can satisfy all of your requirements. Call me a sceptic but from my experience no software can do everything and if you expect the perfect solution then you’re just not being realistic.

I like to refer to the 80/20 rule here…if you can find a solution that can solve 80% of your problems well on a consistent basis then you are onto a winner. The bells and whistles are great but will the everyday user be happy when using this new application?

Remember your end users will make or break the success of any new application roll-out, don’t be blinded by those bells and whistles – usability and intuitiveness are key aspects to consider in my view.

5. Evaluate, Evaluate, Evaluate

In my view is the most important aspect of the entire process.

So your top three vendors are coming back with a corresponding FDS and everything looks great, they are all offering the sun, the moon and the stars but what does the application actually feel like to work with?

It’s paramount at this stage that you get feedback from the people who will actually be using the application on a day to day basis. This will also make them feel more involved in the process and it will even mitigate the push back when you go-live.

Introducing a new way of doing business is always going to be difficult, most people are reluctant to change anyway. In another article I will give my top five tips on how to overcome these challenges when it comes to introducing new software but for now when evaluating each application ask yourself some of these questions.

• Is the software easy to use?
• Is the software intuitive?
• Will other people who are not so tech savvy be able to pick this up?
• How long will it take to train a user?
• How long will it take to train an administrator?
• Will we need help from the vendor after go-live?
• How long will it take to validate this application?
• Does the vendor have a comprehensive QMS we can leverage?

This is really only the tip of the iceberg when it comes to an evaluation process but one more tip, ask each vendor for their technology roadmap.

This is a key document that will tell you where their product is going technology wise and if it still aligns with your business processes.

As your business evolves the software needs to evolve too so it’s important to know that you are buying into a company with a clear vision and foresight.

The Takeaway

So you see choosing the correct vendor and application for your organization is a tricky process and is something that needs to be carefully considered as the wrong decision can have severe impact on your business going forward.

If you have any other insights to give around this topic please use the comments section below.