Quality
At Trinzo, we empower life science companies to bring innovative, quality-driven solutions to market, enhancing patient care and advancing healthcare outcomes. Our commitment is to partner with you in delivering excellence, from concept through compliance.
Trinzos team observe the highest standards of quality within the life sciences industry and we support our clients across a range of services that include Quality System Development, Quality Assurance, Audits, Manufacturing Process Compliance, and Risk Management.
Quality System Development and Enhancement
A Quality Management System (QMS) is the backbone of compliance and operational excellence. Whether refining an existing system or building a QMS from the ground up, our team collaborates closely with yours to design a system that is both resilient and adaptable to industry changes.
- Quality System Regulations (QSR) – 21 CFR 820
- Current Good Manufacturing Practice (cGMP)
- ISO 13485
- EU MDR
- EU IVDR
- MDSAP
Quality Assurance
Our Quality Assurance services are extensive. We know that for leaders mitigating risks from suppliers and throughout production is critical. With Trinzo’s quality engineering support, you gain a robust strategy against compliance risks that could impact production or patient safety.
- Design Quality Assurance (DQA)
- Quality Engineering (QE)
- Supplier Quality Engineering (SQE)
- Quality Systems Support
- Nonconformance
- Corrective and Preventive Actions (CAPA)
- Supplier Corrective Action Request (SCAR)
Audit, Inspection Management and Support
At Trinzo, we prepare clients to face regulatory scrutiny with confidence by offering a range of services.
We recognise that, for leaders, the real value lies in creating a proactive audit-ready culture, developing audit processes and providing readiness training that embed compliance into your everyday operations. During M&A activities, our audit and inspection management services bring both sides of the organisation into alignment, identifying and remediating gaps and ensuring unified compliance post-acquisition.
- Internal audits
- MDSAP audit
- Mock FDA Inspection
- ISO 13485 audit
- 21 CFR 820 audit
- Good Manufacturing Practice (GMP) audit
- Good Distribution Practice (GDP) audit
- MDR QMS audit
- IVDR QMS audit
- QMS Gap Assessment
- Supplier audits
- Audit/Inspection Readiness Training (Trinzo training)
- Audit remediation
- Due diligence Assessments
- Post Acquisition Audits
Manufacturing
Ensuring that manufacturing processes meet business needs and meet stringent regulatory standards is key to protecting product quality and patient safety. Our hands-on, practical support ensures that each stage of manufacturing is compliant, controlled, and optimised.
For organizations growing through acquisition, we ensure aligned manufacturing practices, supporting validation, process stabilization, and standardization for a seamless, compliant transition.
- Technology transfer and line setup
- Process characterisation, development, and enhancement (Process Engineering)
- Labelling
- Qualification & Validation Services
- Design Validation/Product Validation
- Process Validation (IQ/OQ/PQ)
- Computer System Validation
- Capital Equipment Validation
- Facility and Utility Validation
- Packaging Validation
- Sterilisation Validation
Risk Management
Our Risk Management services, built on ISO 14971, provide a systematic approach to identifying, assessing, and managing risks at every stage of the product lifecycle. From early risk assessments during design to comprehensive post-market monitoring, our team supports clients in establishing a risk management process that not only meets regulatory standards but also reinforces patient safety and brand reputation. In M&A scenarios, we integrate risk management practices to unify the risk culture across the organisation, ensuring that product safety remains the priority.
- Medical Device Risk Management (ISO 14971)
- Risk Evaluation
- Failure Mode and Effects Analysis (FMEA)
- Integration with Quality and Regulatory Compliance
- Product Traceability and Recall Readiness
- Risk Management File Maintenance
- Risk Control Measures
At Trinzo, we’re more than just consultants; we’re dedicated partners in your success. Our team is prepared to manage projects of any scale and complexity, giving you assurance through seamless project execution and deep industry expertise.
With our support, Leaders and key stakeholders can trust that quality and compliance initiatives will not only meet today’s rigorous standards but also position their organisations for sustainable growth and patient-centred success in a competitive global market.