GoVal: GxP Compliance and Validation Software
GoVal helps pharmaceutical and biotech companies manage GxP compliance. It is designed for teams moving from paper-based validation to digital, risk-based workflows.
At a glance
- Category
- Operations
- Best for
- Pharmaceutical companies, Biotechnology firms, Medical device manufacturers, Contract Manufacturing Organizations (CMOs), Life sciences companies requiring GxP compliance
- Pricing
- Pricing is custom-based and scoped to the number of validated systems and sites. Standard plans are mentioned for 10-50 users, and Enterprise plans for 50+ users. Buyers should confirm current pricing on the vendor website.
- Key use cases
- Computer System Validation (CSV), Computer Software Assurance (CSA), Equipment Qualification, Audit Preparation
- Official website
- govalidation.com
GoVal is a Validation Lifecycle Management System (VLMS) built on GAMP 5 principles. It is designed for companies in the life sciences sector, including pharmaceutical, biotechnology, and medical device manufacturers, as well as contract manufacturing organizations.
The platform supports teams transitioning from manual, paper-heavy processes to digital workflows. It includes capabilities for Computer System Validation (CSV), Computer Software Assurance (CSA), and Equipment Qualification (IQ/OQ/PQ), focusing on a risk-based approach to compliance.
Buyers should note that the software is designed for regulated environments, with tools to help meet 21 CFR Part 11 and EU GMP Annex 11 standards. Because pricing is custom-scoped based on sites and validated systems, buyers should confirm current pricing on the vendor website.
Key Features
Uses artificial intelligence to support validation and optimization workflows.
Digital document routing, reviews, and electronic signatures to replace physical documentation.
Includes Validation Risk Assessment (VRA) and FMEA-based tools to help define testing scope.
Includes tools designed to help meet 21 CFR Part 11 and EU GMP Annex 11 standards.
Supports the lifecycle of equipment from IQ/OQ/PQ through calibration and maintenance.
Maintains records of actions and changes to support data integrity and audit readiness.
Use Cases
Planning, executing, and documenting the validation of GxP-regulated computer systems.
Applying a risk-based approach to software assurance focused on critical thinking and patient safety.
Managing the qualification process (IQ/OQ/PQ) for manufacturing and lab equipment.
Using reporting and electronic audit trails to support audit readiness.
Best For
Pricing
Pricing is custom-based and scoped to the number of validated systems and sites. Standard plans are mentioned for 10-50 users, and Enterprise plans for 50+ users. Buyers should confirm current pricing on the vendor website.
FAQ
It is used by life sciences companies to perform Computer System Validation (CSV), Computer Software Assurance (CSA), and Equipment Qualification (IQ/OQ/PQ) using digital workflows.
The platform is designed to help organizations meet 21 CFR Part 11 and EU GMP Annex 11 requirements.
Pricing is custom-quoted based on the number of sites and validated systems rather than a per-user headcount.
Source category: Operations
Source subcategory: Compliance Management
