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Compliance Services

Rely on OneSource® Laboratory Compliance Services to give you greater confidence knowing that your lab is operating within global regulatory requirements. By consolidating with one provider and harmonizing your protocols under a single Validation Master Plan (VMP), our OneSource Universal Operational Qualification (UOQ) framework delivers an automated approach to testing, documentation and compliance, streamlining processes across all major models of laboratory instrumentation, regardless of vendor.

  • Full library of IQ/OQ/PQ protocols covering laboratory technologies compliant with international standards
  • Comprehensive suite of solutions for automated and traditional protocols
  • Equipment testing against approved specifications
  • Secure digital archiving of data records for simplified audits
  • Computer system validation—21 CFR Part 11 and GAMP 5
  • Method validation

Explore Our Services

Laboratory Instrument Qualification

OneSource® offers both automated and traditional paper qualification methods and our standard recommended OQ protocols can be customized to your specifications. Our service engineers test instruments against approved specifications and provide final qualification reports using easy-to-review layouts in paper and secure electronic format.

Suited for any size laboratory, our instrument qualification offerings will keep you on the path to an efficient, compliant lab.

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Laboratory Software IQ/OQ

OneSource® provides several IQ/OQ offerings for software qualification and the assurance that instrument data is reliable and consistent for the highest quality results. OneSource validation solutions streamline and supplement your CSV projects and your own CSV deliverables.

We provide several IQ/OQ offerings for your software:

  • Software IQ/OQ for all PerkinElmer Enhanced Security (ES) version instrument software products such as WinLab6 ES, Nexion ES, Spectrum10 ES, etc.
  • Software IQ/OQ for Waters Empower software

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Laboratory UOQ

The OneSource® UOQ program provides an instrumentation qualification program for maximum productivity and ongoing regulatory compliance capability. The program encompasses, where applicable, pharmacopeial (USP, EP and JP) compliance with a design and approach that streamlines documentation across all major models of laboratory instruments, regardless of manufacturer:
  • Simplified OQ with uniform reports
  • Existing data acquisition system
  • Automated
  • Encrypted secure reporting using digital certificate technology to prevent duplication and tampering

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Computer System Validation

OneSource® Computer System Validation (CSV) assists in the planning and implementation of validating computer systems and ensures validation methodology meets regulatory requirements.

Our services are based on 21 CFR Part 11 and GAMP5 ("risk based" approach & V Model documentation). All validations take into account "intended use" and "environment", which is customized based on user requirements (URS). Validations range from full validation for new systems to change control validation for existing standalone and/or enterprise systems.

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Analytical Method Services

Analytical method requirements that span the full lifecycle — from method development and validation to method transfer services — can be time-consuming activities. Leverage the OneSource® team to streamline lab workflows and boost scientific productivity with data integrity assessment and methods to establish quality control procedures that support reliable research data.
  • Method validation with USP<1225> and ICH Q2
  • Metrology and calibration services

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Laboratory Data Integrity

Work with OneSource® to develop a comprehensive Data Integrity Governance Program to ensure the integrity of your laboratory data is intact when faced with audits. The OneSource Compliance team assists in reviewing compliance to ALCOA, the remediation of corrective actions such as CSV, and the creation of necessary documentation to satisfy regulatory requirements.
  • Assessment of systems, documents/policies and environment
  • Scale to customer need
  • Plan of corrective action
  • Remediation
  • Effectiveness check

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