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Q&A: Your IT Roadmap –Guidance for Early-Stage Life Sciences Companies

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Q&A: Your IT Roadmap – Guidance for Early-Stage Life Sciences Companies 

The following questions were asked during the IT Roadmap webinar presented by Erin Christy, Roger Davy, and Hovsep Kirikian. 

Watch the on-demand webinar: Your IT Roadmap – Guidance for Early-Stage Life Sciences Startups

Where do you see data analytics or reporting systems fall in a typical IT strategy? (For example, clinical trials risk-based monitoring and pharmacovigilance [PV] analysis of signal management.) 

As you’re developing your IT roadmap, you’re not just filling a gap with a point solution; the solution must fit the objectives of your company. As you determine which systems you will implement, consider the key performance indicators (KPIs) that will measure the success of that process. Whether it be clinical trials, your quality processes, or supply chain logistics, determine the KPIs you want to track. 

Data provided by those systems can be turned into actionable information so you can move forward to implement improvements, which will turn that actionable information into knowledge and wisdom. 

Reporting analytics vary from company to company, but they live throughout your entire roadmap. 

Which application do you recommend for e-signatures? 

It depends on your business needs, but in the context of standalone e-signature solutions, 80 to 85 percent of our emerging life sciences companies have implemented DocuSign for GxP or Part 11 compliance.  

Some companies have gone with Adobe Sign, but we’re seeing some challenges with the validation process for continuous validation and how they move things from development to production.  

Your key GxP solutions (EDMS, EQMS, ETMF, etc.) will each feature built-in e-signature capability. 

What tool do you recommend for access request in GxP systems that will tie into an eSignature tool like DocuSign? 

USDM has a Part 11-compliant system called ProcessX that we built on top of ServiceNow. It can manage access requests in a scalable and compliant manner. It’s a great tool to help automate and digitize that process. 

When done early and properly, it drives efficiency in a growing organization because it’s automatically tracking access requests. 


I have used HP Application Lifecycle Management (ALM) electronic validation testing in the past. Are there others that are worth exploring? 

There are a number of ALM tools available, such as HP ALM or Kneat.  USDM currently uses SpiraTeam for electronic and automated testing. When selecting any tool, especially an ALM, it is important to understand the use cases and business requirements to ensure the best system is implemented to meet your company’s objectives. 

USDM has vast experience with electronic and automated testing platforms and a robust vendor selection process to help you find the best solution for your needs.  


What is the most important thing to consider when selecting GxP applications? 

Begin by understanding and documenting your business requirements, then carefully evaluate solutions against those requirements. Evaluate how the solution will meet your requirements. There is a big difference between having something work out-of-the-box and performing extensive configuration (or worse, customization). Make sure that you can validate and sustain the application within your environment strategically and long term.  


How do we determine if we should align to a single platform or implement best-in-class point solutions? 

The good thing about implementing best-in-class point solutions is that each business unit is working with the best system for that process. However, there are a lot of cross functional touchpoints and the integration of systems often don’t work as marketed once they’re implemented, which leads to manual processes at those integration points resulting in errors, bandwidth consumption, and operational inefficiency. 

Fewer platforms allow for technical and operational alignment, which decreases the overall cost of ownership of the system and increases operational efficiency and audit readiness. A strategic IT roadmap is key and will help you determine where it might be OK to diverge into a best-in-class point solution. 

Other factors to consider: Support for various systems requires multiple system administrators with varied skill sets and increases administrative costs. Multiple platforms require multiple sets of administration policies and procedures. Each vendor has a different release schedule, so maintaining compliance amongst releases and enhancements is daunting. Also, end-user adoption is much higher with systems that have a similar user interface. 


How many people should I plan for in my IT organization to keep my cloud validations updated? 

Depending on the number of GxP systems, this could be significant and require two to three full-time employees. USDM’s Cloud Assurance managed service maintains your system if you need additional support, including initial validation after implementing your system. 


How do we align functional units that have historically worked in silos? 

As emerging companies grow organically, we see a lot of business units implement point solutions as the need arises, but they don’t have a lot of visibility or alignment with other groups. In the process of building out an IT roadmap, they get to hear from other functional areas and understand the pain points. 

Keep your stakeholders involved while you build out your IT roadmap to help them understand the benefits of cross-functional alignment. Establish a unified approach to IT systems implementation and roadmap planning. 


Additional Resources 

GxP QMS Framework Prepares Emerging Biopharma for Commercialization 

Rapid Deployment of Enterprise-Wide GxP Applications 

CSV Program and Application Validation in Less than 6 Weeks 

Continuous GxP Cloud Compliance 


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