Quality Assurance Architecture
Explore the four operational pillars governing laboratory operations, electronic chromatography data systems, and sponsor audit defense.
Comprehensive Quality Management Architecture
Our QMS is engineered to provide end-to-end trace control from sample intake through analytical testing, chromatographic integration, and final CoA issuance.
Standard Operating Procedures (SOPs)
Documented procedures covering instrument operations, analytical calibrations, sample chain of custody, and out-of-specification (OOS) investigations.
Internal Audit Program
Cross-functional internal audits conducted by trained lead auditors assessing compliance against SOPs, cGLP protocols, and validation packages.
Management Review & Metrics
Senior leadership review of QMS performance, key quality indicators, customer feedback, calibration drift, and risk mitigation strategies.
Change Control System
Formal change management process evaluating potential risk before modifying instrumentation, analytical methods, software, or lab facilities.
ALCOA+ Data Integrity Matrix
Every chromatogram, titration curve, and spectral printout generated at Jarvogen adheres to ALCOA+ principles. Click any principle below to view our laboratory implementation.
Attributable
Who generated the data?
How We Implement This in Lab Operations:
Individual user logins, biometric/password authentication, and unique digital timestamps ensure every measurement is traced to a verified analyst.
Client & Regulatory Audit Support
We welcome customer qualification audits and regulatory inspections. Our dedicated Quality Assurance team facilitates pre-audit questionnaires, transparent documentation review, and on-site facility tours.
Pre-Audit Technical Questionnaires
Completed and returned within 3 to 5 business days with all licenses and certifications attached.
On-Site Independent Escort
Dedicated conference room, real-time SME availability, and rapid document pull within 10 minutes.
Virtual Document Room (VDR)
Secure remote audit sessions with screen-sharing and watermarked digital SOP inspections.
Formal CAPA Resolution within 15 Days
Comprehensive root cause analysis and corrective action commitments backed by evidence.
Audit Track Record
100% Satisfactory outcomes across recent evaluations
Quality Dossiers & Site Documentation
Accelerate your vendor pre-qualification by requesting official summaries of our site governance documents.
Site Master File (SMF) Summary
Overview of Jarvogen facility layout, HVAC classifications, analytical capabilities, and organizational structure.
Quality Manual & Policy Overview
High-level summary of QMS hierarchy, SOP index categories, risk management, and ALCOA+ data integrity commitment.
Validation Master Plan (VMP) Summary
Lifecycle qualification strategy for HPLC, LC-MS/MS, GC-MS, ICP-MS, and computerized systems.
Vendor Audit & Pre-Qualification Dossier
Standard pre-audit questionnaire answers, license copies, organizational chart, and key contact details.
Ready to Initiate a Vendor Qualification?
Schedule an on-site audit, request a Quality Agreement, or speak directly with our Head of Quality Assurance.