Biotech Validation.
Built for Biologics Complexity.
GoVal gives biotech and biologics teams a structured, paperless validation platform — from LIMS qualification and ATMP system validation to multi-site harmonisation. Fast enough for biotech timelines. Rigorous enough for GxP inspections.
What is biotech validation software?
Biotech validation software is a digital platform that manages qualification and validation workflows for GxP-regulated biotechnology systems — including LIMS, ELN, bioreactor control software, and ATMP manufacturing systems. GoVal is a purpose-built Validation Lifecycle Management System (VLMS) that replaces paper-based protocols with compliant digital workflows, fully aligned with GAMP 5, 21 CFR Part 11, EU Annex 11, and ICH Q10 — designed to keep pace with the speed of biotech development without sacrificing compliance rigour.
Validation Shouldn't Slow Your Biotech Pipeline
Biotech companies face the same GxP requirements as pharma — but with greater system complexity, faster timelines, and more evolving processes.
Compressed Timelines
IND filings, clinical milestones, and CMC packages move fast. Traditional paper-based CSV creates validation backlogs that delay critical program milestones.
Complex Landscapes
LIMS, ELN, bioprocess MES, and custom analytical systems each require a maintained validated state — and each changes frequently as methods evolve.
ATMP Complexity
Cell and gene therapy programs face novel manufacturing processes with no standardised validation templates — leaving QA to build everything from scratch.
Multi-Site Inconsistency
R&D, clinical, and commercial sites each maintain their own validation documents — creating version control nightmares and inconsistent inspection outcomes.
One Platform for All Biotech Workflows
GoVal brings validation planning, risk assessment, test execution, traceability, and approvals into a single cloud-native platform — configurable for biologics and ATMP operations.
GAMP 5 Risk Classification
Classify LIMS, ELN, bioprocess control, and analytical systems under GAMP 5 categories — automatically generating proportionate IQ/OQ/PQ scope and documentation requirements.
Paperless IQ/OQ/PQ Execution
Run Installation, Operational, and Performance Qualification protocols digitally — with real-time pass/fail recording, deviation capture, and automated RTM linking.
ATMP & Cell Therapy Templates
Configurable validation templates for novel ATMP manufacturing processes — cell culture, viral vector, and gene editing platforms — while preserving full GxP traceability.
Change Control Management
Manage impact assessment, re-validation scope, approval workflows, and post-change verification for fast-changing biotech software — with full audit trail integrity.
Multi-Site Harmonisation
Maintain a single validated template library for consistent validation standards across R&D, clinical, and commercial manufacturing sites — globally.
Audit-Ready at All Times
Real-time project dashboards, electronic audit trails, and one-click inspection packages — so your biotech validation programme is always ready for FDA or EMA inspection.
Built for Every Biotech Compliance Framework
GoVal satisfies the full regulatory stack for biotech and biologics validation — from FDA GMP to EU Annex 2 and ATMP-specific guidance.
Electronic Records
Compliant audit trail, e-signatures with meaning statements, and access control for all GxP electronic records.
Computerised Systems
European computerised system requirements and biologics GMP expectations for digital validation documentation.
Risk-Based Framework
Software categorisation, risk-proportionate testing, and critical thinking documentation for biotech GxP systems.
Quality by Design
Quality risk management, pharmaceutical quality systems, and API development standards embedded in every workflow.
Faster Validation. Stronger Compliance.
Pre-built templates and automated approvals compress validation cycles — so systems go live on schedule.
From COTS LIMS to custom ATMP manufacturing software — GoVal handles every GAMP 5 category.
One platform grows with your programme — from Phase I validation through commercial site harmonisation.
Continuous audit readiness replaces document reconstruction — every validation record is inspection-ready.
Biotech Validation Questions Answered
What is biotech validation software?
Biotech validation software is a digital platform managing qualification workflows for GxP-regulated systems — LIMS, ELN, bioprocess MES, and ATMP manufacturing platforms. GoVal replaces paper protocols with compliant digital workflows aligned with GAMP 5, 21 CFR Part 11, and EU Annex 11.
What validation regulations apply to biotech companies?
Key frameworks include FDA 21 CFR Part 11 (electronic records), EU GMP Annex 11 and Annex 2 (computerised systems and biologics), ISPE GAMP 5 Second Edition, ICH Q8/Q9/Q10/Q11, and FDA 21 CFR Part 211. GoVal is purpose-built to satisfy all these in one platform.
Can GoVal support cell and gene therapy (ATMP) validation?
Yes. GoVal's configurable templates and workflows support novel ATMP manufacturing systems — cell culture, viral vector, and gene editing platforms — while preserving full GxP traceability, approval controls, and audit trail integrity required by FDA and EMA.
How does GoVal handle GAMP 5 classification for biotech systems?
GoVal's risk engine applies GAMP 5 categories (1–5) to each system, automatically generating proportionate test scope and documentation requirements. This ensures validation effort is matched to actual compliance risk rather than applied uniformly to every system.
How does GoVal support multi-site biotech validation?
GoVal provides a centralised template library, role-based access control, and cross-site dashboards. R&D, clinical, and commercial manufacturing sites work from the same controlled framework — ensuring consistency and harmonisation across your global biotech network.
How does GoVal manage change control for evolving biotech software?
GoVal captures change requests, performs GxP impact assessment, routes e-signature approvals, scopes re-testing requirements, and preserves post-change evidence — maintaining a continuously validated state for fast-moving biotech system environments.