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
Quick Summary
Early-stage life sciences companies often build their technology stack one point solution at a time, leaving gaps, integration headaches, and compliance debt that surface during growth and inspections. In this Q&A, USDM experts answer the most common IT roadmap questions emerging biopharma teams ask — where analytics fit, how to choose e-signature and GxP applications, how to staff cloud validation, and when to consolidate platforms versus picking best-in-class point solutions. The throughline: start with business requirements and KPIs, plan the roadmap before you buy, and design for validation and sustainability from day one.
Where do data analytics and reporting systems fit 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. Building that reporting layer on trustworthy, controlled inputs matters — analytics are only as reliable as the data feeding them.
Roadmap first, point solutions second. Every system you add should map back to a documented business objective and a measurable KPI. A point solution that doesn't advance the roadmap adds cost, integration risk, and validation burden without advancing the mission.
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. Whichever route you choose, the signature workflow has to hold up to 21 CFR Part 11 scrutiny — electronic records and electronic signatures must be attributable, secure, and audit-ready.
What tool do you recommend for access requests in GxP systems that tie into an e-signature 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.
Do it early and properly, and access management drives efficiency as you grow — because every request is tracked automatically instead of chased manually.
I have used HP Application Lifecycle Management (ALM) for electronic validation testing. Are there others 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. Modern validation testing also pairs well with a computer software assurance (CSA) approach, which focuses effort on critical-thinking and risk rather than exhaustive documentation.
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.
A simple GxP application selection sequence
- Document business requirements. Capture what the system must do before you look at vendors.
- Evaluate against requirements. Score each solution on how well it meets the documented needs — not the demo.
- Weigh configuration vs. customization. Out-of-the-box is cheaper to validate and sustain; customization compounds cost and risk over time.
- Confirm you can validate and sustain it. Make sure the application fits your long-term environment strategy, not just today's gap.
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. Consolidating where it makes sense is also a third-party risk management win — fewer vendors means fewer supplier qualifications, security reviews, and release cycles to govern.
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.
FAQ: IT Roadmaps for Early-Stage Life Sciences Companies
Where do data analytics and reporting fit in an IT roadmap?
Reporting and analytics live throughout the entire roadmap rather than in a single system. Start by defining the KPIs you want to track — across clinical trials, quality, or supply chain — so the data those systems produce can be turned into actionable information, knowledge, and ultimately better decisions.
Should an emerging biopharma consolidate on one platform or buy best-in-class point solutions?
Best-in-class point solutions give each business unit its preferred tool, but cross-functional integrations frequently underdeliver, creating manual workarounds, errors, and inefficiency. Fewer platforms lower total cost of ownership, improve audit readiness, and raise user adoption. A strategic IT roadmap helps you decide where diverging to a point solution is justified.
How many people does it take to keep cloud validations current?
Depending on how many GxP systems you run, keeping validations updated can require two to three full-time employees. A managed service such as USDM Cloud Assurance can maintain systems and handle initial validation when in-house bandwidth is limited.
What matters most when selecting a GxP application?
Document your business requirements first, then evaluate solutions strictly against them. Understand the gap between out-of-the-box functionality and heavy configuration or customization, and confirm you can validate and sustain the application long term within your environment.
How do you align teams that have worked in silos?
Use the roadmap-building process itself as the alignment mechanism. Bringing functional areas together to share pain points and keeping stakeholders engaged establishes a unified approach to systems implementation and reduces redundant, disconnected point solutions.
Build the roadmap before you buy the systems. USDM helps early-stage life sciences companies define requirements, select and validate GxP applications, and sustain compliance as they scale. Contact us to talk through your IT roadmap, or explore USDM Cloud Assurance for ongoing validation support.
Additional Resources
GxP QMS Framework Prepares Emerging Biopharma for Commercialization
Rapid Deployment of Enterprise-Wide GxP Applications