TOP-TIER GLOBAL PHARMACEUTICAL COMPANY

SHORTENS VALIDATION CYCLE TIME BY 50%

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.