CSV / CSA
Computer System Validation and Computer Software Assurance support for regulated systems, workflows, and software-enabled operations.
Parsippany, New Jersey • Regulated Quality + Validation Engineering
Quality, validation, and computer system assurance for regulated operations.
Top Quality Validation Engineers supports pharmaceutical, biotechnology, medical device, laboratory, manufacturing, and regulated IT teams with validation strategy, requirements traceability, test evidence, data integrity, and audit-ready documentation.
Core services
Traceability + Testing
Requirements-to-test traceability, test strategy, test scripts, execution evidence review, deviations, and validation summary reporting.
Data Integrity + Part 11
Audit trails, access controls, electronic records, reporting evidence, data lifecycle, and controlled documentation support.
Regulated Workflow QA
Quality and validation support for intake, queues, workflows, business rules, document review, reporting, and integrations.
Regulated systems support
Top Quality supports prime contractors, platform vendors, systems integrators, and regulated operations teams that need quality, validation, traceability, testing documentation, and release-readiness discipline for complex workflow and software-enabled programs.
Across regulated business and technical environments, Top Quality can support the quality and validation layer around:
- Requirements and process intake
- Queue and task management
- Configurable workflows and business rules
- Document and evidence review
- Scheduling and coordination workflows
- Controlled document workflows
- Quality review and release readiness
- Integrations and reporting
- User roles and permissions
- Responsible AI-enabled workflow support
Experience base
Top Quality draws from 10+ years of validation and quality engineering experience across regulated environments, including work associated with Pfizer, Medline, Merck, Edwards Lifesciences, Cook Medical, Jabil, and Stryker.
Validation lifecycle
Validation plans, URS/FRS, FAT/SAT, IQ/OQ/PQ, TMV protocols, traceability matrices, and summary reports.
Quality systems
GAMP 5, 21 CFR Part 11, cGMP, ISO 13485, ISO 14971, FMEA, SPC, MSA, CAPA, and change control.
Audit-ready evidence
Objective evidence packages, SOP/training support, deviation documentation, review-cycle closure, and data integrity controls.
Need a validation and documentation workstream partner?
Top Quality can support regulated workflow, software assurance, and documentation teams as a specialist subcontractor or quality/validation workstream partner.
info@topqualityvalidationengineers.com