Aligning with a Technology and Service Provider: A Guide for Life Sciences Teams

Aligning with a Technology and Service Provider: A Guide for Life Sciences Teams

As a follow up to the “13 Common Issues in CSV” series that we did over the first few weeks of January (find part 1 here, if you haven’t read that yet), I thought it would be appropriate to take it to the next step and look at a few things that life sciences companies should be evaluating when aligning with a technology and/or service provider.

As made clear in that series, it’s evident that the life sciences industry is faced with a unique set of guidelines and therefore has a unique set of requirements that need to be addressed.  Those unique requirements and pain points should then dictate that when evaluating technology or services from an outside vendor, that they, in turn, should be uniquely qualified to meet those requirements before you even consider partnering with them.

This means that any old service or technology provider just won’t do.  You need someone that speaks your language.  You need someone that brings with them not just an understanding of industry requirements, but actual knowledge and applied experience.  You need someone that you can truly partner with.

So what should you be looking for?  Here are a few items that should help you identify and align with the right type of provider.

1: They should be experts in FDA regulations/guidelines and regulated software quality.

There’s not much to say here and it almost goes without saying, but this needs to be a requirement for your team if you are bringing someone in to execute software project work in a regulated environment.  When I say this, I don’t mean finding a company that checked a box in their profile stating that they have worked with life sciences organizations or have worked on validated application projects.  I mean you should be aligning with a provider that focuses exclusively on the life sciences vertical or at least has a practice that is solely dedicated to it.

Finding an organization that not only has resources with industry expertise, but that also has a clear and defined vision around maximizing efficiency within the confines of regulatory requirements is paramount to the success of the projects you engage them on, the products that you buy from them and, ultimately, the long term investment in the relationship you have with them.

The world of regulations and guidelines is often confusing and continues to change.  Make sure you can leverage your partner and their expertise to navigate those waters as effectively as possible.  You certainly want to avoid getting in situations where your team is handcuffed by self-imposed, bloated processes that hinder productivity and business objectives due to a “better safe than sorry” approach to appeasing regulatory requirements.

A good partner will make sure that doesn’t happen.

2: They should be offering compliance solutions that enable adaptability commensurate to the progress of the rest of the technology landscape.

A partnership with a life sciences focused organization does not always just mean a services and project-based relationship.  If you are looking for tools and solutions to help streamline or overhaul your current software quality and CSV practices, then you should make sure the technology is forward-thinking.  That it enables the ability to adapt to and facilitate the ever-changing technology and methodology landscape.

There are many providers out there who have built solutions around legacy validation methodologies, but those tools largely just add a limited amount of gains to processes and methodologies that are dated at this point (no matter how comfortable or familiar they might feel).  They will do little in truly pushing forward your testing and validation efforts to align with ever-increasing demands from business and development teams.

The goal should be implementing solutions that put your team ahead of the curve.  You should be looking at solutions that enable innovation, efficiency gains and risk reduction in the face of regulatory compliance. The solutions you evaluate should offer flexibility, allowing for the adoption of modern SDLC solutions and methodologies, whatever those may be now and down the road. 

To be sure, this means moving away from paper documents, but ultimately, moving away from documents altogether.  

For example, a solution that enables a data-driven methodology vs. document-centric approach to validation will support a much nimbler infusion and execution of compliance activities within SDLC solution sets and processes.  Not to mention this will enable your traditional “validation” deliverables to simply be a byproduct of good software quality practices, rather than an overly onerous, additional process that has to be executed in addition to standard software development and quality practices.

3: They should have a verifiable track record of long term, strong partnerships with both customers and technology providers.

This is crucial.  You want to know that a technology and/or service partner that you are going to put your trust in has a long and successful track record of maintaining relationships with their existing customers.  Be wary of a checkered, transactional past.  This should be a partnership, after all.  You want to be able to lean on their expertise as a trusted advisor.  The desired outcome should be a provider that is an extension of your own team.

You want the assurance that their tools have been successfully utilized by organizations and teams similar to yours. Assurances that they have delivered greater efficiencies in regulatory compliance than their customers were able to accomplish on their own.  Be sure that they have a staff of resources to deliver, install, manage, train and support your organization as new software is deployed or existing systems are modified or upgraded.

It’s okay to ask for references.  Just as important, make sure you actually speak with those references!

Don’t just look at their customers, though.  Make sure that the provider you are potentially going to work with is partnered with key and market-leading technology companies as well.  This should ensure that the provider’s development teams are staying up to speed with the technologies that their solutions integrate with, or work in conjunction with.  It should also give some assurances that the team and resources you are engaging with on the project side of things are well versed in the technologies they will be recommending or deploying for your team. 

As an added bonus, this should also allow you to make your new vendor somewhat of a “one-stop-shop” for your regulated SDLC needs.  The fewer providers you have to engage with on various evaluations or projects, the simpler your life and job will be (not to mention the cost savings of working with fewer vs. more providers)!

If you didn’t get a chance to reference the “13 Common Issues in CSV” series that prompted this post, you can go back and check out part 1 here.

As always, if you would like to discuss any of this in more detail, please feel free to reach out to us and reference that you read this blog.

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