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🔐 Dual ISO Certified · GDPR Compliant

Security & Integrity
Built for Pharma

GoValidation combines ISO 27001 information security with ISO 9001 quality assurance and ALCOA+-enforced data integrity — a single platform Life Sciences organisations can validate, audit, and trust.

Explore Data Integrity
Enterprise Security

Defence in Depth,
Validated by Design

GoValidation's security architecture is independently certified to ISO 27001:2022 — covering every layer from infrastructure to access control to incident response.

01

Encryption Without Compromise

AES-256 at rest and TLS 1.3 in transit — no exceptions, no legacy protocols, and no unencrypted pathways within the platform.

  • AES-256 encryption at rest, every tenant
  • TLS 1.3 enforced for all data in transit
  • Encrypted database backups with geographic redundancy
  • No plaintext storage of any regulated data
02

Access Control That Enforces Accountability

RBAC with MFA and SSO integration ensures only authorised individuals can access or approve records — with a complete log of every interaction.

  • Configurable role-based access control (RBAC)
  • Multi-factor authentication (MFA) by default
  • SSO integration via SAML 2.0 / OIDC
  • Tamper-proof session audit logs
  • Automatic session expiry and inactivity lockout
03

Complete Organisational Isolation

Row-level security at the database layer guarantees no data — intentionally or inadvertently — ever crosses tenant boundaries.

  • Row-level security (RLS) per tenant at database layer
  • No cross-organisation data sharing, ever
  • Isolated processing environments per organisation
  • No data used for AI/LLM model training
04

Resilience & Business Continuity

Point-in-time recovery with a 2-minute RPO and a documented, annually tested disaster recovery plan keep your validation data available under any conditions.

  • Point-in-time recovery with 2-minute RPO
  • Recovery period configurable up to 28 days
  • Automated daily backups with integrity verification
  • Disaster recovery plan tested annually
  • Geographic data residency options
⭐ ALCOA+ Framework

Trust Your Data.
Prove It to Regulators.

GoValidation enforces ALCOA+ at the database layer — every record leaves an unalterable trail from input to signature.

A Attributable
L Legible
C Contemporaneous
O Original
A Accurate
+ Complete
+ Consistent
+ Enduring
+ Available

Aligned with FDA Data Integrity Guidance (2018), PIC/S PI 041-1 (2021), WHO TRS 996 Annex 5, and ISPE GAMP Data Integrity by Design.

01

Immutable Audit Trail by Architecture

Every action is captured in a computer-generated, time-stamped audit trail that cannot be altered or deleted — previous record versions are preserved in full.

21 CFR Part 11.10(e)Annex 11 §9PIC/S §4.3
02

Version Control & Document Lifecycle

Documents move through a controlled lifecycle with unique version identifiers and workflow-enforced approvals — only the current approved version is available for execution.

EU GMP Annex 11 §7.1ICH Q10GAMP 5
03

Electronic Signatures & Non-repudiation

Signatures are cryptographically bound to their records and capture identity, role, date, time, and meaning — fully aligned with 21 CFR Part 11 Subpart C.

21 CFR Part 11 Subpart CEU Annex 11 §12
04

Validated Data Capture & Deviation Management

Structured capture enforces input validation and mandatory fields at entry — deviations are logged with root cause and corrective action for a traceable, audit-ready record.

FDA Data Integrity Guidance 2018WHO TRS 996 Annex 5
05

Multi-Layer Data Protection & Recovery

AES-256 at rest, TLS 1.3 in transit, and 2-minute RPO point-in-time recovery — with geographic data residency options for EU and other required jurisdictions.

GDPR Article 32ISO 27001 A.12.3ISO 9001 §8.5.2
Why GoValidation

The Standard Others Are Measured Against

Unique Differentiator

ISO 27001 and ISO 9001 — Both

GoValidation holds both ISO 27001:2022 and ISO 9001:2015, closing the supplier qualification gap under EU GMP Annex 11 §3 — a combination no other GxP validation platform offers.

Global Compliance

GDPR-First, Not GDPR-Added

Architected with GDPR from day one — EU data residency, data subject rights, Privacy Impact Assessments, and Data Processing Agreements are standard, not add-ons.

Deeper Coverage

ALCOA+ at the Database, Not the UI

ALCOA+ constraints are enforced via database-layer triggers and row-level security — no application-layer workaround or misconfiguration can circumvent them.

Transparent Value

Honest, Predictable Pricing

No hidden compliance surcharges, no per-module fees for audit trail access — every feature your regulators require is included, not gated behind a higher tier.

Common Questions

Answers for
Regulated Teams

Questions commonly asked by Quality Managers, Validation Engineers, and IT Security leads evaluating GxP platforms.

Yes. GoValidation holds ISO 27001:2022 certification for Information Security Management Systems (ISMS). The certification is independently audited and renewed annually, covering access control, encryption, incident response, and business continuity. Documentation is available under NDA upon request.
Yes — and this is a meaningful differentiator. ISO 9001:2015 certifies GoValidation's internal Quality Management System covering software development, testing, release, and support. This can satisfy part of the computerised system supplier audit requirements under EU GMP Annex 11 §3.
GoValidation processes personal data lawfully under GDPR Article 6 and offers Data Processing Agreements (DPAs) as standard. Personal data can be stored within EU / EEA jurisdictions. Data subjects may exercise rights to access, rectification, erasure, restriction, portability, and objection at any time.
Under 21 CFR Part 11.10(e), systems must use computer-generated, time-stamped audit trails to independently record operator entries that create, modify, or delete electronic records. GoValidation meets this through database-level triggers that log every write operation with an immutable timestamp and user identity — independent of the application layer.
ALCOA+ requires all GxP data to be Attributable, Legible, Contemporaneous, Original, and Accurate — plus Complete, Consistent, Enduring, and Available. GoValidation enforces these architecturally: attribution through role-based identity binding, contemporaneous capture via real-time database triggers, and accuracy through validated input controls and range checks.
GoValidation encrypts all data at rest using AES-256 and all data in transit using TLS 1.3. Each organisation's data is stored in isolated database schemas with row-level security, ensuring complete logical separation between tenants. No plaintext data is stored anywhere in the platform.
GoValidation offers EU / EEA hosting for European customers. Data residency is agreed at onboarding and documented in your Data Processing Agreement. No data is transferred outside the agreed jurisdiction without explicit written consent.

Ready to Get Started

See What a Dual ISO‑Certified
Validation Platform Looks Like

Join Life Sciences organisations across Europe and North America who chose GoValidation for its unmatched combination of security, data integrity, and compliance coverage. A 45-minute guided demo covers your specific regulatory environment.

No commitment · 30 minutes · Tailored to your regulatory context