GxP Compliance.
End to End. Always Audit-Ready.
GoVal unifies electronic records, e-signatures, data integrity controls, and validation workflows in a single GxP-compliant platform — so your team stays inspection-ready 365 days a year.
What is GxP compliance in the pharmaceutical industry?
GxP compliance refers to the collection of Good Practice regulations — GMP, GLP, GCP, and GDP — that govern quality, safety, and data integrity across pharmaceutical and life sciences operations. In digital environments, GxP compliance requires electronic records and signatures that satisfy FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity principles. GoVal is a purpose-built GxP compliance platform that operationalises these requirements through validated, audit-ready digital workflows.
GxP Compliance is Still Running on Paper and Spreadsheets
Fragmented quality systems, manual approval chains, and disconnected validation tools create inspection risk that accumulates silently — until an auditor arrives.
ALCOA+ Violations Hidden in Plain Sight
Paper records cannot enforce contemporaneous data entry, prevent backdating, or guarantee attributability — making ALCOA+ compliance structurally impossible without a validated digital system.
Fragmented Quality Systems
Validation records in SharePoint, deviations in email threads, signatures in wet ink, and CAPAs in Excel — each disconnected tool is a gap in your GxP compliance record that regulators will find.
Audit Preparation Takes Weeks
Retrieving, reconstructing, and printing validation records for FDA or EMA inspectors consumes weeks of QA team time that should be spent on productive compliance activities.
No Cross-System Visibility
Validation status, open deviations, pending reviews, and overdue periodic qualifications exist in siloed systems — making enterprise GxP risk management practically impossible.
One Platform for Full GxP Compliance Lifecycle
GoVal replaces fragmented paper and spreadsheet workflows with a unified, validated digital environment that enforces GxP compliance at every step.
ALCOA+ Enforcement by Design
Every record is automatically Attributable, Legible, Contemporaneous, Original, and Accurate — enforced by the system, not left to individual discipline. Complete, Consistent, Enduring, and Available through immutable audit trails.
21 CFR Part 11 & EU Annex 11 E-Signatures
Compliant electronic signatures with meaning statements, unique identity binding, and tamper-evident records — satisfying both FDA and European regulatory requirements without wet ink.
Real-Time Compliance Dashboards
Consolidated view of validation status, open deviations, overdue periodic reviews, and pending approvals — across all systems and sites. Continuous inspection readiness, not periodic preparation.
Immutable Audit Trail
Every system action — record creation, modification, approval, and deletion — is permanently timestamped and user-attributed. Tamper-evident records that satisfy both FDA and EU regulatory review standards.
Structured Change Control & Deviation Management
Enforce GxP-compliant change control workflows with impact assessments, re-validation triggers, and electronic approval chains — so every system change is documented and defensible.
Multi-Site Enterprise Scalability
Centralise GxP compliance management across multiple manufacturing sites, laboratory facilities, and global geographies — with site-specific configuration and enterprise-wide visibility.
Compliance That Works Without the Overhead
Audit-ready documentation at all times — not rebuilt in the two weeks before an FDA or EMA visit.
Eliminate the data integrity, traceability, and e-signature gaps that drive the majority of FDA inspection observations.
One system of record for validation, quality, and regulatory activities — no more reconciling data across SharePoint, email, and Excel.
From a single-site LIMS validation to a global multi-system compliance programme — GoVal scales without adding compliance risk.
Aligned with Every Major GxP Framework
21 CFR Part 11
Electronic records and electronic signatures for FDA-regulated pharmaceutical, biotech, and medical device manufacturers in the US.
EU GMP Annex 11
European Medicines Agency computerised systems requirements for GMP-regulated pharmaceutical manufacturing and quality control in Europe.
ISPE GAMP 5
Industry standard for risk-based validation of GxP computerised systems — the risk classification and testing methodology at the core of GoVal.
ICH Q10
Pharmaceutical Quality System guideline from ICH — GoVal change control, CAPA, and deviation workflows are designed to align with ICH Q10 principles.
ALCOA+ Data Integrity
FDA and MHRA data integrity requirements — Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available.
FDA CSA Guidance
FDA's 2025 Computer Software Assurance final guidance — risk-based, critical-thinking software assurance aligned with GAMP 5 Second Edition categories.
Common GxP Compliance Questions
What does GxP stand for in pharmaceuticals?
GxP is a collective term for Good Practice guidelines in life sciences — including Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Distribution Practice (GDP). Each framework establishes standards that protect product quality and patient safety at different stages of the pharmaceutical lifecycle.
What is GxP compliance software?
GxP compliance software manages quality and regulatory workflows — validation, electronic records, e-signatures, audit trails, CAPA, and change control — in a manner that satisfies FDA 21 CFR Part 11, EU Annex 11, and ALCOA+ data integrity requirements. GoVal is purpose-built for life sciences GxP compliance.
How does GoVal enforce ALCOA+ data integrity?
GoVal enforces all ALCOA+ attributes by design: every record is user-Attributable, system-timestamped for Contemporaneity, structured for Legibility, captured as Original electronic data, and validated for Accuracy. Complete, Consistent, Enduring, and Available attributes are maintained through immutable audit trails and controlled retention policies.
Can GoVal manage GxP compliance across multiple manufacturing sites?
Yes. GoVal is a multi-site enterprise platform that manages validation and quality workflows across multiple facilities, system types, and geographies — with centralised compliance dashboards and role-based access that scale from a single site to a global network without increasing compliance risk.
How does GoVal improve inspection readiness?
GoVal provides continuous inspection readiness through real-time dashboards showing validation status, open deviations, pending approvals, and overdue periodic reviews — across all systems. Audit trails and validation records are retrieved in seconds during an FDA or EMA inspection, not reconstructed over days.
What regulatory frameworks does GoVal support?
GoVal supports FDA 21 CFR Part 11, EU GMP Annex 11, ISPE GAMP 5 Second Edition, ICH Q10 Pharmaceutical Quality System, ALCOA+ data integrity principles, and FDA Computer Software Assurance (CSA) 2025 final guidance — providing a unified compliance framework for global pharmaceutical and life sciences organisations.
How is GxP compliance different from computer system validation?
GxP compliance is the broader regulatory framework governing quality, safety, and data integrity across life sciences. Computer System Validation (CSV) is one specific component — documented evidence that a computerised system performs as intended in a GxP environment. GoVal covers both: it is the validated system through which your CSV and broader GxP compliance activities are executed and recorded.