View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
PerkinElmer|7 June 2022

Regulatory & Compliance – Meet GMP 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.

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.

Extractables and leachables studies are critical for maintaining the quality of your drug product during drug development and final batch release in accordance with GMP...
The FDA defines data integrity as “completeness, consistency, and accuracy of data. Complete, consistent, and accurate data should be attributable, legible, contemporaneously recorded, original or...
Globalization of the pharmaceutical industry has led to increasing demands on regulatory agencies across the globe to ensure the quality, safety, and effectiveness of medicines.
When a new drug is first developed by a pharmaceutical company, it is initially sold under a brand name and the product is covered under...
NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. A weekly roundup of the latest news and analysis, sent every Friday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Pharmaceutical Technology