Quality management
Quality & Compliance
Defensible data built on scoped validation, calibrated instruments, and rigorous documentation standards.
Quality Management System
Our quality management system supports reliable, traceable, and defensible analytical results. Regulated workflow steps — from sample receipt to final report — are documented, reviewed, and evaluated against defined acceptance criteria.
Standard Operating Procedures govern all laboratory activities. Instruments are calibrated with NIST-traceable reference standards. All data undergoes second-person review before release.
Quality Status at a Glance
A practical view of how quality frameworks are scoped and what clients receive.
| Framework | Status | What clients receive |
|---|---|---|
| GLP / 21 CFR Part 58 | Studies available under defined GLP procedures, where scoped | Protocol, raw data traceability, QA review, final report |
| cGMP documentation | Available for applicable pharma testing | Controlled records, second-person review, ALCOA+ practices |
| 21 CFR Part 11 | Part 11-aligned controls for scoped electronic records/signatures | Audit trails, access controls, signature records, validation evidence |
| Computer System Validation | Risk-based validation evidence maintained for regulated workflows | Intended-use scoping, controlled changes, test evidence, periodic review |
| ISO 17025 | Aligned, not accredited unless/until accreditation is obtained | Method validation, uncertainty, proficiency-testing practices |
Regulatory Frameworks
21 CFR Part 58 — GLP
Studies available under defined GLP procedures where scoped, with protocol, raw data traceability, QA review, and final report documentation.
cGMP Compliance
cGMP documentation is available for applicable pharmaceutical testing, including controlled records, second-person review, and ALCOA+ data integrity practices.
21 CFR Part 11
Part 11-aligned electronic records and signatures are used for scoped regulated workflows, with audit trails, access controls, signature manifestations, and validation evidence supporting data integrity.
Computer System Validation
Validation evidence is maintained using intended-use scoping, risk assessment, role-based responsibilities, controlled change records, test evidence, and periodic review.
ISO 17025 Aligned
Practices are aligned with ISO 17025 expectations for method validation, uncertainty, and proficiency testing; Synergy Science Solutions is not ISO 17025 accredited unless or until accreditation is obtained.
Key Quality Practices
Instrument Calibration
All instruments calibrated with NIST-traceable standards on documented schedules. System suitability tests run before every analytical sequence. Calibration records maintained and available for client audit.
Method Validation
Methods validated for specificity, linearity, accuracy, precision, range, LOD/LOQ, and robustness per ICH Q2(R2) and CIPAC guidelines. Validation reports available on request.
Data Review & Integrity
All raw data reviewed by a second qualified scientist. Electronic audit trails maintained. Final reports include method references, acceptance criteria, and conclusions with supporting chromatograms.
Documentation Standards
Questions About Our Quality Program?
Ask about audits, documentation, or regulatory compliance support.