UJTech ValidSolutions partners with pharmaceutical, biotech, and medical device companies to deliver expert CSV/CSA validation, business analysis, and project management — so your regulated systems stay compliant, your requirements are airtight, and your projects land on time.
In pharma, biotech, and medical device environments, a single gap in validation, a misaligned requirement, or a delayed go-live can derail an FDA audit, stall a product launch, or trigger costly rework. Companies don't lack effort — they lack the specialized expertise to get it right the first time.
Incomplete validation packages and missing traceability create avoidable findings that damage your regulatory standing.
When business needs aren't captured precisely, system implementations miss the mark — leading to rework, delays, and frustrated stakeholders.
Without experienced PM leadership, regulated system go-lives drift — scope creep, vendor delays, and resource gaps compound fast.
Defects and gaps found late in a project cost 5–10× more to fix than issues caught during planning and requirements.
We take full ownership of your computer system validation — from planning through execution — ensuring every deliverable meets FDA expectations and withstands scrutiny.
We bridge the gap between what your business needs and what your systems deliver — capturing requirements with precision so implementations succeed the first time.
PMP-certified project leadership that keeps your regulated system implementation on track — on time, in scope, and in full compliance — from kickoff to go-live.
We start by understanding your system, regulatory context, and risk profile before a single protocol is written.
A tailored validation or project plan built around your timelines, resources, and compliance requirements.
Rigorous protocol execution, defect tracking, and documentation that leaves no gaps for auditors to find.
Complete validation packages, summary reports, and a system your team can confidently maintain and operate.
We work with companies where regulatory compliance isn't optional — from global pharmaceutical manufacturers to growing biotech startups navigating their first FDA submission.
Our clients range from Fortune 500 pharmaceutical and biotech leaders to emerging med-tech companies, all with one thing in common: they can't afford a validation failure.
GMP-regulated systems, manufacturing execution, quality management
Clinical data systems, lab information management, regulatory submissions
21 CFR Part 820, design controls, QMS system validation
CTMS, EDC, eTMF validation and GCP compliance support
Embedded validation support for internal ERP, LIMS, and cloud migrations
Whether you're planning a new system implementation, facing an upcoming audit, or need embedded validation support — we'd like to hear about it. Send us a message and we'll follow up within one business day.