Regulatory & Compliance | PerkinElmer

Regulatory & Compliance

The increasingly complex regulatory environments have forced laboratories to adopt a new mindset to compliance and auditing… moving away from traditional instrument validation approaches and consolidating both the instrument data as well as the instrument support across the full spectrum of their lab assets.

OneSource® Laboratory Compliance Services advances cohesiveness and confidence knowing that your labs are operating within global regulatory requirements.

By consolidating with one provider – OneSource - and harmonizing your protocols under a single Universal Operational Qualification framework, you’ll have a comprehensive, 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

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

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 analysis spans their full lifecycle to keep you on the path to an efficient, productive and compliant lab.

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Consumables & Accessories

Your partnership with PerkinElmer doesn't stop when you purchase an instrument. We also have a complete line of consumables and accessories engineered to keep t ...

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Drug Substance Assay

Inspections of drug substances are designed to confirm manufacturing plants, as well as the quality control laboratory, follow CGMP regulations. An extensive se ...

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Cleaning Validation

Regulatory authorities expect pharmaceutical companies to have written standard operating procedures (SOPs) detailing the cleaning processes used for various pi ...

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Pharmaceutical Raw Material Identification

The analysis of all incoming pharmaceutical raw materials is a key part of GMP compliance to guarantee safety and efficacy of a finished dosage form which is la ...

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Excipients Characterization

The quality of excipients is extremely important since 90% of medicines are made up of them. When it comes to regulatory guidelines, there are several the indus ...

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Polymorphic Forms

During the process of manufacturing finished dosage forms (solids), an organic molecule can adopt more than one crystalline form which can have significant effe ...

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Explore Our Regulatory & Compliance Services

Laboratory Instrument Qualification

Instrument Qualification methods guide your lab through automated, secure electronic or traditional paper qualification procedures with standard OQ protocols cu ...

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