Compliance & Validation Support
Compliance designed in.
Not bolted on after.
From GAMP-aligned engineering through to ATEX-certified equipment and 21 CFR Part 11-ready software — compliance is the foundation of every Terriva system, not an optional extra.
Frameworks supported
GAMP · GxP · Part 11 · ATEX
Documentation
Approach
Industries
Four frameworks. One regulated environment.
Pharmaceutical manufacturing operates inside multiple overlapping regulatory frameworks. Each Terriva compliance page explains what one framework covers, how Terriva supports it, and why it matters for your operation. Start with the one most relevant to your project — or work through all four if you’re scoping a new system end-to-end.
Regulatory framework
GAMP & GxP
Covers
- GMP
- GLP
- GAMP 5
- Risk-based validation
Electronic records
21 CFR Part 11
Covers
- Audit trails
- E-signatures
- Role-based access
- Data integrity
Explosive environments
ATEX
Covers
- Zone 1
- Zone 2
- Zone 21
- Zone 22
- Dust & vapour
Project deliverables
Validation documentation
Covers
- URS
- FAT
- SAT
- Compliance docs
- Operator manuals
Why pharmaceutical manufacturers choose Terriva for compliance
We speak your language
We're specialists in GxP, GAMP, Part 11 and ATEX requirements, so we're on the same page as your QA, validation and engineering teams.
Compliance designed in
Not an add-on or a retrofit. Compliance is engineered into Terriva systems from specification through manufacturing.
Multi-framework expertise
One supplier across GAMP, GxP, Part 11 and ATEX — fewer vendors, simpler validation, consistent documentation.
Faster validation cycles
Documentation packs aligned with your validation framework from day one — no lengthy briefing or rework cycles.
Procurement confidence
QA teams approve framework-aligned suppliers faster — easing internal procurement and supplier qualification.
Long-term partnership
Ongoing support for system changes, upgrades and revalidation as your regulatory environment evolves.
Compliance threaded through every product
Pharmatech
Containment Systems
Service & Support
Controls & software
Next steps
Need a compliance-led solution for your facility?
Our team will review your regulatory environment, recommend the right framework alignment, and scope the documentation, validation and ongoing support that fits your project.
