8/12/2019 ValGenesis Case Study With Global Pharma - Golbal
Rollout With Pharma | Validation Software Solution | ValGenesis
Review
1/2
TOP-TIER GLOBAL PHARMACEUTICAL COMPANYSHORTENS 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 o
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 expectfrom
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 thewalking around and mailing time
byproviding simultaneous access tomultiple reviewers and approvers
atdifferent sites. This solution eliminatespaper, duplication, and
waiting. But itsgreatest value is in helping uscommunicate
effectively.
Validation ManagerQU 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 assets100% 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
accessingdocuments needed in preparing for audits. The work
eventually
got done, but with more manual effort, duplication, and time
than
necessary given the technologies available.
8/12/2019 ValGenesis Case Study With Global Pharma - Golbal
Rollout With Pharma | Validation Software Solution | ValGenesis
Review
2/2
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
companysrequirements out-of-the-box and was implemented,
validated, and put into production in 12 weeks, on time and
onbudget. 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-timeaccess 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% ofthe
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 andmore 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 ValidationQU Validation and Validation Systems
THE RESULTS:
A streamlined, 100% electronic approach to ValidationLifecycle
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 94538Phone:
1-888-825-4363 | (510) 445-0505Fax: (510) 991-9901
www.valgenesis.com | email: [email protected]
Copyright 2014 ValGenesis, Inc. All rights reserved.
