Information Technology (IT) is the backbone of any life sciences company and is necessary for collecting, archiving, and analyzing complex data.
Quick Summary
- A strategic IT roadmap connects your technology investments to business milestones, regulatory applications, and GxP requirements so you spend on what matters next.
- USDM delivers expert assessments and value-driven roadmaps across G&A, lab, clinical, quality, manufacturing, and other regulated systems.
- The right roadmap keeps your organization running, continuously compliant, and ready to scale, whether you are pre-commercial or integrating companies during M&A.
What technology to choose? With the abundance of hardware, software, and database technologies on the market, compatibility is key. Does your life sciences company have the resources and ability to research and implement technology that will keep you up and running and continuously compliant?
When the technology is in place, who will ensure that employees are well-trained on the software and following established procedures? How will you maximize the return on investment (ROI) of your IT investments?
USDM Life Sciences provides expert assessments and value-driven roadmaps to identify critical business needs and enable your organization to improve its data, application, and technology capabilities. This includes documenting your processes, procedures, and business requirements and working together to prioritize systems, develop timelines for implementation, and select vendors.
In these short videos, Erin Christy, VP of Emerging Life Sciences and Clinical Solutions, discusses the importance of an IT Roadmap and when your emerging company should implement one.
Watch the full-length on-demand webinar, Compliant IT Strategies for Life Sciences
An IT roadmap is more than a technology shopping list. It is a sequencing decision: which systems to stand up first, how to keep regulated data trustworthy from day one, and how to validate each system efficiently so compliance never becomes the bottleneck to growth.
Building a Compliant IT Roadmap
When it comes to building a compliant IT roadmap, USDM has the knowledge and experience to get you to your desired destination. We will:
- Identify business imperatives for IT investments
- Align IT investments with key milestones and regulatory applications
- Select IT platforms and solutions to support your business objectives
- Prioritize implementation
- Provide budget estimates and resource requirements
- Assess required skills and capabilities, headcount, and budgets
Because so many of these systems fall under GxP, the roadmap also has to account for how each one will be validated and kept in a state of control. A modern approach using computer software assurance (CSA) focuses validation effort on risk, helping you bring systems online faster without compromising compliance. Building 21 CFR Part 11 requirements into platform selection from the start avoids costly retrofits for electronic records and signatures later.
How USDM Sequences a Strategic IT Roadmap
- Assess. Document your processes, procedures, and business requirements, and evaluate existing technology, talent, and maturity.
- Prioritize. Map IT investments to business milestones and regulatory applications so the most critical systems come first.
- Select. Choose platforms and vendors that fit your regulated use cases and integrate cleanly with your existing stack.
- Validate & sustain. Implement with a risk-based validation approach and keep systems continuously compliant as they evolve.
A roadmap turns a pile of technology choices into a sequenced plan that aligns every investment with the next business milestone and regulatory requirement.
Unique IT Roadmaps for Unique Life Sciences Needs
Whether you are a pre-commercial emerging company or a global pharma company integrating multiple companies amid M&A events, USDM addresses your company’s needs for talent, maturity, existing technology, and business strategy.
From your general and administrative (G&A) systems to lab, clinical, quality, manufacturing, and other GxP systems, we know the technology and we know how to optimize it. We have more than two decades of experience applying life sciences best practices, we’ve built a large network of technology partners, and we understand the fundamentals for future-proofing your IT strategy.
Across every one of these systems, the data they generate has to be trustworthy. Designing for data integrity at the roadmap stage keeps your records reliable as data flows between systems. Pairing the right platforms with a disciplined validation lifecycle management practice and ongoing Cloud Assurance keeps those systems compliant long after go-live, even as vendors push frequent updates.
Download our Emerging Life Sciences datasheet to see a sample IT Roadmap for regulated and non-regulated needs. We can help you customize this.
USDM’s Life Sciences Technology Expertise Includes:
- Building Management Systems
- Clinical Systems (CDMS, CTMS, EDC, eTMF, ePRO, IRT)
- Content Management Systems
- Enterprise Resource Planning (ERP)
- Equipment Qualification
- e-Signature
- Freezer Systems
- Laboratory Systems (ELN, Freezer Management, LIMS)
- Manufacturing Systems (ERP, PLM)
- Quality Systems (LMS, Quality Document Management, QMS)
- Regulatory Publishing
- Safety Systems and Signal Detection
- Submissions
- UDI & Serialization
- and more
Select Technology Partners We Work With to Ensure Their Technology Is Fit for Regulated Use:
- AWS
- Box
- ComplianceQuest
- DocuSign
- IQVIA
- Microsoft
- Okta
- Oracle
- PTC
- Salesforce
- ServiceMax
- ServiceNow
- TraceLink
- TrackWise
- Veeva
- And many more
FAQ: Strategic IT Roadmaps for Life Sciences
What is a strategic IT roadmap for a life sciences company?
It is a value-driven plan that identifies critical business needs and aligns your data, application, and technology investments with key business milestones and regulatory applications. It documents your processes and requirements, prioritizes which systems to implement and when, sets timelines, and guides vendor selection.
When should an emerging life sciences company build an IT roadmap?
Earlier than most teams expect. Building the roadmap before you scale lets you align IT investments with upcoming milestones and regulatory applications, avoid incompatible point solutions, and stand up systems in a sequence that supports growth instead of slowing it down.
Which systems does an IT roadmap cover?
Everything from general and administrative (G&A) systems to regulated GxP systems, including lab systems (ELN, LIMS, freezer management), clinical systems (CDMS, CTMS, EDC, eTMF, ePRO, IRT), quality systems (QMS, LMS, document management), manufacturing (ERP, PLM), regulatory publishing, submissions, safety and signal detection, and UDI and serialization.
How does USDM keep roadmap systems compliant?
USDM applies a risk-based validation approach and ongoing compliance support so systems stay in a state of control after go-live. This includes computer software assurance practices, designing for data integrity, and continuous compliance services that keep validated systems current as vendors release updates.
Can a roadmap support M&A or integrating multiple companies?
Yes. USDM builds roadmaps for global pharma companies integrating multiple organizations during M&A events, accounting for existing technology, talent, maturity, and business strategy to rationalize and harmonize systems.
Ready to Build Your IT Roadmap?
USDM can help you assess your current state, prioritize the right systems, and keep them continuously compliant. Contact USDM to start discussing your strategic IT roadmap today.