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ValGenesis and QbD Pharmaceutical Services Partner to Deliver Best-in-Class Quality by Design and Process Validation and Verification Services for Life Sciences Companies

ValGenesis News | Published: September 30, 2022

San Francisco, September 30, 2022: ValGenesis, Inc and QbD Pharmaceutical Services have partnered to deliver best-in-class quality by design and process validation and verification services for the life sciences industry across Europe and South America.

ValGenesis is the market leader in enterprise Validation Lifecycle Management Systems (VLMS), helping the world’s leading life sciences companies enforce compliance and enable standardization with 100% digital, risk-based validation software.

QbD Pharmaceutical Services S.L, founded in 2015 in Barcelona, delivers high added-value services and specialized outsourcing solutions to pharmaceutical and biopharmaceutical companies. GxP compliance and validation, Lean-Six Sigma projects to increase efficiency in regulated environments, and specialized support for Quality by Design/PAT deployment are their focus areas of activity.

In this partnership, QbD Pharmaceutical Services will implement and manage next-generation digital risk management, process validation verification tools developed by ValGenesis, enabling clients to further strengthen quality by design and process validation and verification across the GMP lifecycle. Both companies are working to release the full potential of digital transformation for clients, providing them with the best course for success in the new digital validation landscape.

“With digital technology playing an increasingly critical role in the life sciences industry today, companies realize the need to go completely digital to ensure that they remain compliant and competitive,” says Bo Olsen, ValGenesis’ SVP of Partners, and Head of Europe. “Our partnership with QbD Pharmaceutical Services brings together the best of both our companies’ deep quality by design, risk management, process validation and verification, and digital technology implementation skills that can help our clients through successful business transformations,” he stated.

“QBD PS is in a collaboration agreement with ValGenesis to continue representing the iRISK and iSEE platforms of 4TUNE Engineering, which has recently become a ValGenesis company,” says Alicia Tébar, Founder and Owner of QbD Pharmaceutical Services. “The objective of this agreement is to facilitate digitalization for biopharmaceutical companies in the areas of knowledge management and risk management (iRISK), and in real-time process monitoring and control management (iSEE). QBD PS's experience in Quality by Design and PAT aligns with the power and functionality of these platforms designed to digitize the entire life cycle of processes and make continuous validation a reality,” she stated.

About QbD Pharmaceutical Services

QbD Pharmaceutical Services delivers high value-added services and specialized outsourcing solutions to pharmaceutical and biopharmaceutical companies. The company comprises a seasoned consultancy team with 20 years’ experience in pharma and more than 100 projects delivered for 40 different companies in Europe and South America. For more information, visit https://www.qualitybydesign.es/

Further Information

Enrique Morillas, QbD Pharmaceutical Services, +34 937 37 11 29,

info@qualitybydesign.es

 

About ValGenesis

ValGenesis, Inc. is the creator of an innovative software platform that serves as a foundation for managing compliance-based validation activities in life science companies. ValGenesis, Inc. is the provider of the first enterprise application that manages the corporate validation lifecycle process.

This solution is fully compliant with U.S. FDA 21 CFR Part 11 and Annex 11 requirements. As the first fully paperless solution for electronic management of validation execution and approval, ValGenesis was selected by an industry peer review committee to receive the Parenteral Drug Association (PDA) New Innovative Technology Award in 2005.

For more information, visit www.valgenesis.com

Further information:

Althea D’Sylva, ValGenesis Communications, +1 510-445-0505 Ex.1026 althea.dsylva@valgenesis.com

Summary

In this partnership, QbD Pharmaceutical Services will implement and manage next-generation digital risk management, process validation verification tools developed by ValGenesis, enabling clients to further strengthen quality by design and process validation and verification across the GMP lifecycle. Both companies are working to release the full potential of digital transformation for clients, providing them with the best course for success in the new digital validation landscape.

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