Client Review:
“ValGenesis spares us the
walking around and mailing time by
providing simultaneous access to
multiple reviewers and approvers at
different sites. This solution eliminates
paper, duplication, and waiting. But its
greatest value is in helping us
communicate effectively.”
— Validation Manager
QU Validation and Validation Systems
Título original
ValGenesis Case Study With Global Pharma - Golbal Rollout With Pharma | Validation Software Solution | ValGenesis Review
Client Review:
“ValGenesis spares us the
walking around and mailing time by
providing simultaneous access to
multiple reviewers and approvers at
different sites. This solution eliminates
paper, duplication, and waiting. But its
greatest value is in helping us
communicate effectively.”
— Validation Manager
QU Validation and Validation Systems
Client Review:
“ValGenesis spares us the
walking around and mailing time by
providing simultaneous access to
multiple reviewers and approvers at
different sites. This solution eliminates
paper, duplication, and waiting. But its
greatest value is in helping us
communicate effectively.”
— Validation Manager
QU Validation and Validation Systems
The Challenge: Laborious Processes, Too Much Paper At the time, most global life sciences organizations were attending to their critical validation initiatives through manual or, at best, hybrid approaches. For the client company, several validation consultants and subject-matter experts (SMEs) were involved in the paper-based validation process for the project initiative being revamped. This effort alone required interoffice and courier routing for review and approval of more than 200 documents per month on average.
The company was s seeking a validation solution that would deliver similar ROI improvements that it had come to expect from other enterprise systems (ERP, DMS, LIMS, MES, and OMS). It needed a forward-thinking approach eventually leading to 100% electronic validation lifecycle management.
ValGenesis spares us the walking around and mailing time by providing simultaneous access to multiple reviewers and approvers at different sites. This solution eliminates paper, duplication, and waiting. But its greatest value is in helping us communicate effectively.
Validation Manager QU Validation and Validation Systems
A leading global pharmaceutical company was seeking a validation solution that would deliver similar ROI improvements that it had come to expect from other enterprise systems. Today more than 1000 global users collaborate via the ValGenesis Validation Lifecycle Management solution to review protocols and manage the validation status of more than 5,500 GxP assets 100% electronically. THE SOLUTION: Technology for Consistency and Compliance
The company had been working diligently towards discovering a robust validation management software solution to manage validation processes electronically. The department director initiated a search with the overarching goal of creating leaner, more efficient processes for validation across the organization. Continue
The request came from the companys QU Validation and Validation Systems department working from a US site for global biotechnology manufacturing and product supply operations. Validation documents and change control requests associated with several key products were approved by stakeholders across company sites in the US and Europe.
The department faced challenges commonly associated with paper-based validation: inefficient leveraging of validation resources, documents misplaced during transit, legibility issues, and laborious processes for interoffice approval and for accessing documents needed in preparing for audits. The work eventually got done, but with more manual effort, duplication, and time than necessary given the technologies available.
The Implementation: Rapid Start-up and Global Expansion Continued Through this initiative, the department was looking to improve upon a 100% paper-based process for validating computer systems, equipment, processes, facilities, and methods. It determined that the ValGenesis Validation Lifecycle Management Solution (VLMS) offered significant advancements over the current validation process: increased efficiency, reduction in validation lifecycle times, improvements in regulatory compliance, and a holistic view of validation projects. ValGenesis was selected from three competing proposals.
ValGenesis was configured to meet more than 95% of the companys requirements out-of-the-box and was implemented, validated, and put into production in 12 weeks, on time and on budget. The ValGenesis Rapid Implementation Methodology also helped the information technology and validation experts at the company to manage other projects simultaneously. It was initially rolled out to 175 users to manage requirements for computer systems (CSV), equipment, instruments, methods, cleaning, and process validation.
ValGenesis offered the ability to migrate from paper toward 100% electronic validation, with strong customer support during and after the transition. The project-level implementation was deemed a success, based on measurable improvements in document routing and consistency.
One year later, the department implemented an additional ValGenesis module to manage change control as a closed-loop process with validation. Through this upgrade, users could create their own process flows and descriptions, to indicate the required justification for changes made within a validated system.
Within the next two years, the ValGenesis solution was extended to a global biologics development division for validation documents required in the state-of-the-art manufacturing processes for new products and also to a supply center in Europe. A fourth site was brought on board several months later.
ValGenesis today streamlines the validation process for more than 1000 users across four company global sites. Real-time access to validation documents and data enables various stakeholders to achieve compliance collaboratively and efficiently. The Validation department has met its ROI goals and continues to add departments and sites.
From the US department, the director and ValGenesis system owner provide access to each on-site SME assigned to ValGenesis. Supporting ValGenesis typically represents 25% of the local SMEs responsibilities.
The SME configures the system, creates workflows, and registers equipment numbers. ValGenesis Inc. provides ongoing support and training through a solutions support team. New users also have access to a web-based training module for ValGenesis. More and more people are interested in using the system because they see how easy it is to complete the validation deliverables in less time. ValGenesis has become our system of record for validation and change control, with more usage than any other software system within our department.
Director of Validation QU Validation and Validation Systems
THE RESULTS:
A streamlined, 100% electronic approach to Validation Lifecycle Management.
Convenient, real-time access by over 1000 stakeholders at four sites globally as they manage the validation status of more than 5,500 GxP assets. Over 10,000 validation protocols reviewed and approved and 3,000 validation documents electronically executed, reviewed, and approved during the rollout. A multi-tenant, web-based system accessible from almost anywhere. Easy virtual collaboration, better visibility, and accountability, with simultaneous review and approval of validation documents by various stakeholders throughout the company.
Compliance through intertwined change management and validation processes. A complete genealogy of change requests for internal and external audits.
Simplified, rapid document development with authoring templates and test functions. Met deadlines for periodic reviews and revalidation schedules.
Reduced validation cycle time by 50% and reduced overall cost of the validation process by 20-30%. ValGenesis, Inc 42840 Christy St. | Suite 102, Fremont, CA 94538 Phone: 1-888-825-4363 | (510) 445-0505 Fax: (510) 991-9901 www.valgenesis.com | email: info@valgenesis.com Copyright 2014 ValGenesis, Inc. All rights reserved.