News / 23 Jul, 2019

Arkivum demonstrates alignment with regulated Life Sciences data management requirements including GxP regulations, award of ISO 9001 and ISO 27001 certifications and successful customer and partner audits

Arkivum, the leading provider of long-term data management and digital preservation solutions, today announced it has achieved pharma-level compliance with the award of ISO 9001:2015 certification, demonstrating alignment with data-related GxP regulations, re-certification of ISO 27001:2017 and successfully completing pharma audits initiated by pharma companies.

 

Serving the highly regulated life science entities and helping them manage their long-term data requires the highest standards of data safeguarding and integrity, digital preservation, access and policies. Arkivum has successfully implemented its GxP integrated quality management system which is aligned with ISO 9001, 27001 and all applicable GxP regulations requirements – including 21 CFR Part 11 – into one central process. Arkivum’s products, processes and systems are developed and operated alignment with:

  • ISPE GAMP® 5: Compliant GxP Computerized Systems
  • FDA 21 CFR Part 11, 210, 211, 820
  • EU Commission: EudraLex Volume 4 GMP Annex 11
  • ICH (International Council for Harmonisation) E6, E9, Q7A, Q9, Q10
  • MHRA GxP Data – Guidance for Industry
  • ISO 9001:2015 – international standard for a quality management system (QMS)
  • ISO 27001:2017 – information security management

 

During the month of June 2019 alone, Arkivum has successfully completed pharma and life sciences customer-initiated audits including enterprises from Switzerland, UK and the US; biopharmaceutical disruptor companies, CROs and multi-national conglomerates.

 

Guy Yaniv, CEO of Arkivum says “Arkivum takes great pride in providing our customers and partners with a state-of-the-art solution and service to manage their long-term data. With that goal in mind, we have invested heavily in our products, processes and systems to ensure our customers enjoy a robust software that delivers the highest standards and requirements set forth by the various GxP standards and guidelines”.

 

Arkivum’s Non-Executive Director, Dr David Brindley, expert in GxP regulated life science applications added: “The global life science industry has a critical need for the secure and GxP validated long term management of its data, spanning complete product lifecycles – R&D, manufacturing, clinical evaluation, distribution and pharmacovigilance. Arkivum is proud to be a recognised and trusted partner, validated by existing clients and third-party auditors.”

 

View our ISO 9001:2015 certificate.

View our ISO 27001:2017 certificate.

Emma Davenport

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