Supporting GxP manufacturing environments.
Terriva supports pharmaceutical manufacturers operating in regulated GxP environments, where process control, traceability, data integrity and validation are critical — with control systems and software solutions designed to support GAMP-aligned project expectations.
Framework
GAMP 5 aligned
Standards
GMP · GLP · GDP
Approach
Risk-based validation
Documentation
Good Practice
A general term used across regulated industries — particularly pharmaceutical manufacturing — covering Good Practice requirements across multiple disciplines.
Includes:
- GMP manufacturing
- GLP laboratory
- GDP distribution
In essence: ensuring regulated processes are controlled, consistent, traceable and capable of supporting patient safety and product quality.
Good Automated Manufacturing Practice
Focus areas:
- Patient safety
- Product quality
- Data integrity
Promotes a risk-based approach to ensure automated systems are fit for intended use and compliant with applicable regulations.
How they fit together
How Terriva supports GxP and GAMP
Our control systems and software upgrade solutions can be designed to support customer requirements across the dimensions that GxP and GAMP frameworks address.
21 CFR Part 11
Audit trails, electronic records, validated e-signatures.
Audit trails
Tamper-resistant logging of every operator and system action.
User access control
Role-based permissions matched to operational responsibility.
Electronic records
Secure, validated batch records and process data.
Validation documentation
URS, FAT, SAT and supporting documentation packages.
Where required, Terriva can work with customers to support GAMP-aligned project expectations — helping ensure automated and computerised systems are fit for intended use within regulated pharmaceutical manufacturing environments.
The GAMP risk-based approach in practice
GAMP doesn’t prescribe identical validation effort for every system. Instead, it promotes a risk-based approach — applying the validation effort that matches the actual risk to patient safety, product quality and data integrity.
1. Understand the system
Define the system, its purpose, and the regulated processes it supports.
2. Assess the risk
Identify risks to patient safety, product quality and data integrity.
3. Scope the validation
Apply validation effort proportionate to the identified risk level.
4. Document fitness
Provide evidence the system is fit for intended use and compliant.
Why this matters for your operation
We speak your language
Familiarity with GxP and GAMP frameworks means we speak the same language as your QA, validation and engineering teams.
Faster project delivery
Validation timelines compress when the supplier understands what's needed without lengthy briefing cycles.
Reduced regulatory risk
Working with a supplier who understands the frameworks reduces the risk of compliance gaps during inspection.
Smoother system integration
Specifying, integrating and validating new equipment is materially easier when both parties share frameworks.
Ongoing compliance maintenance
Long-term partnership for system changes, upgrades and revalidation as your regulatory environment evolves.
Procurement confidence
QA and validation teams approve framework-aligned suppliers faster — easing the procurement path.
GAMP & GxP across the Terriva offer
GAMP and GxP support appears across multiple parts of the Terriva offer — wherever automated systems, validated equipment or regulatory documentation matters.
Pharmatech
Controls & software
Service & Support
21 CFR Part 11
Next steps
Need GAMP-aligned or GxP-compliant systems for your facility?
Our experienced team will review your regulatory environment, recommend the right system specification and walk you through validation support.
