Validation and quality work that stands up to inspection.
Computer system validation, equipment qualification and quality-system support for regulated manufacturers.
Every regulated product depends on equipment, processes and software that are proven fit for purpose, and on a quality system that can show it. Stark Associates provides validation engineers and quality professionals who do that work to the standard inspectors expect.
Computer system validation
We validate GxP computerized systems using a risk-based approach aligned with GAMP 5 and 21 CFR Part 11: validation planning, requirements, risk assessment, test protocols and execution, traceability, and summary reports. We also support periodic reviews, change control and data-integrity assessments for systems already in use.
Commissioning and qualification
For equipment, utilities and facilities, our engineers prepare and execute installation, operational and performance qualification protocols, manage deviations found during execution, and deliver complete qualification packages ready for quality approval.
Quality-system support
When backlogs build up, our quality specialists help with deviation investigations, root-cause analysis, CAPA, change control, document control and supplier quality. We can also support quality management system improvements under ISO 13485 or 21 CFR 820 for device manufacturers.
Audits and inspection readiness
Mock inspections, internal audits and supplier audits give an honest view of where you stand. Findings are prioritized so your team can fix what matters most first.
How engagements work
We agree deliverables and acceptance criteria up front. Work follows your procedures or ours, and every protocol and report is written for the reviewer who will read it later.
When clients call us
Typical triggers are a new line or system that must be qualified before launch, or a CAPA backlog ahead of an inspection.
Others ask for help after an audit: an observation needs a credible remediation plan, or a periodic review shows that a validated system has drifted from its documented state. We assess the gap, propose a plan with realistic dates, and staff it with engineers who have done the same work before, so your quality team can stay focused on approvals rather than authoring.
Validation we deliver
- Computer system validation
- Equipment validation
- Process validation
- Cleaning validation
- Medical device validation
Our aim is a compliance approach your team can sustain: people, processes, tools and methods combined so that each validation package builds on the last instead of starting from scratch.