PerkinElmer OneSource Laboratory Compliance Services

Overview

PerkinElmer OneSource Laboratory Compliance Services is a comprehensive, science-driven qualification and validation program engineered for laboratories operating under regulated environments—including pharmaceutical, biotechnology, clinical diagnostics, and contract research organizations (CROs). Built upon PerkinElmer’s deep domain expertise in analytical instrumentation and regulatory science, OneSource delivers end-to-end support for instrument lifecycle compliance, from initial procurement through retirement. The service applies risk-based, science-led qualification methodologies aligned with current industry standards—specifically ASTM E2500 (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment), USP <1058> (Analytical Instrument Qualification), and ICH Q2(R2) (Validation of Analytical Procedures). Unlike generic calibration-only offerings, OneSource integrates technical verification with documented evidence generation, ensuring instruments perform as intended within their defined operational context and maintain data integrity throughout use.

Key Features

• Risk-informed IQ/OQ/PQ protocols pre-developed for over 50 common laboratory platforms—including chromatography systems (HPLC, UHPLC, GC), spectrophotometers (UV-Vis, FTIR), mass spectrometers, thermal analyzers, and sample preparation equipment
• Full computerized system validation (CSV) compliant with FDA 21 CFR Part 11 and ISPE GAMP 5 guidelines, including audit trail review, electronic signature implementation, and role-based access control assessment
• Customizable protocol development to reflect site-specific standard operating procedures (SOPs), facility infrastructure constraints, and process-critical performance parameters
• Traceable execution against manufacturer specifications, user requirements specifications (URS), and applicable regulatory thresholds—with deviation management and CAPA linkage capability
• Secure, cloud-accessible documentation repository supporting version-controlled reports, raw test data, and metadata archiving for up to 30 years per client-defined retention policy
• Dedicated compliance consultants with minimum 8 years’ hands-on experience in GxP-regulated validation projects across APAC, EMEA, and North America

Sample Compatibility & Compliance

OneSource supports qualification of instruments used across analytical testing, stability studies, microbiological analysis, and quality control laboratories. Compatibility extends to both PerkinElmer-branded systems (e.g., QSight™ LC-MS/MS, Lambda™ UV-Vis, TGA 8000) and third-party equipment—provided technical documentation and firmware versions meet minimum interoperability criteria. All qualification activities conform to ISO/IEC 17025:2017 (General requirements for the competence of testing and calibration laboratories) for measurement traceability, and align with EU Annex 11 (Computerised Systems) and WHO TRS 937 Annex 5 (Validation of Computerized Systems). Documentation packages are structured to satisfy internal audit readiness and external inspections by regulatory authorities including the FDA, EMA, PMDA, and NMPA.

Software & Data Management

The OneSource digital workflow utilizes a secure, validated document management platform hosted in ISO 27001-certified data centers. All qualification reports are generated in PDF/A-2u format with embedded digital signatures compliant with eIDAS and FDA Part 11 requirements. Audit trails capture user identity, timestamp, action type, and data changes—retained independently of primary records. Integration with LIMS and ELN systems is supported via configurable API endpoints, enabling automated transfer of qualification status and expiry alerts. Electronic record retention follows ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available), with annual integrity verification and periodic backup validation performed per SOP-QA-017.

Applications

• Accelerated commissioning of new analytical labs or expansion projects under tight timelines
• Maintenance of continuous compliance during routine instrument requalification (e.g., post-maintenance OQ, annual PQ)
• Support for regulatory submissions requiring full instrument history (e.g., IND, NDA, MAA dossiers)
• Remediation of legacy systems lacking formal validation documentation
• Training and knowledge transfer for in-house QA/QC teams on qualification methodology and inspection preparedness
• Gap assessment and remediation planning for upcoming FDA or EMA inspections

FAQ

Does OneSource provide calibration certificates traceable to national standards?
Yes—calibration services are performed using reference standards accredited to ISO/IEC 17025, with traceability documented to NIM (China), NIST (USA), or PTB (Germany) via recognized calibration chains.
Can OneSource support multi-site global validation programs?
Yes—standardized templates, centralized reporting dashboards, and regional compliance leads ensure consistent execution across geographies while respecting local regulatory interpretations.
Is method validation included in the standard service scope?
Method validation (e.g., specificity, linearity, precision per ICH Q2(R2)) is offered as a modular add-on, coordinated with instrument qualification to ensure alignment between system performance and analytical procedure requirements.
How is data security managed during remote qualification activities?
Remote access is conducted via PerkinElmer’s ISO 27001-certified secure gateway; no local data export occurs, and all sessions are logged, encrypted, and terminated automatically after completion.
What happens if an instrument fails a PQ test?
A formal deviation report is issued, followed by root cause analysis and corrective action planning—coordinated with engineering and vendor support where applicable—to restore conformance prior to report finalization.