How to Calculate

the ROI of
Digitized
Validation

Find out how much time and money you

could save by digitizing your validation
processes with the #1 VLMS provider to
valgenesis.com the life sciences.
Calculating the Value:
Digitized Validation
Virtually every aspect of operations in every industry can be improved by adopting and
employing smarter technology that simplifies workflows, yields more reliable data, and
accelerates time to market. The life sciences industry is no exception.

Regulatory authorities recognize the advantages of going A paperless VLMS helps regulated companies overcome the
digital and encourage the industry to embrace technology unique and difficult challenges that slow their development
tools. One example is the FDA’s computer software and manufacturing processes. But how do you convince
assurance (CSA) guidance. The International Society for stakeholders the cost is worth the price tag?
Pharmaceutical Engineering’s revised GAMP 5® guide (GAMP
5, Second Edition) is another. The message is clear: to stay The first half of this guide explores the leading causes
competitive and compliant, life sciences manufacturers of digital resistance in the life sciences industry — and
must move out of legacy comfort zones and into the digital challenges them with compelling arguments you can use to
world. advocate for change in your organization.

The adoption of a digitized validation lifecycle management The second half backs up these arguments with real ROI
system (VLMS) is one of the best opportunities for digital data from real ValGenesis customers. We break down every
transformation because the ROI is so clear. stage of the validation lifecycle — looking at both core and
supporting validation activities — and detail the efficiencies
gained at each step. Armed with knowledge and numbers,
you can build a bulletproof business case for digitizing
To stay competitive and compliant, life sciences
validation.
manufacturers must move out of legacy comfort
zones and into the digital world.

2 How to Calculate the ROI of Digitized Validation

Reasons for
Digital Resistance
There has never been higher pressure
to develop drugs and devices faster and
more cost-effectively. Everyone wants
a competitive edge — the secret sauce
that will reduce the cost of production,
ship products to market sooner, and
ultimately generate more revenue.
Technology provides that edge.

The life sciences industry has invested significantly in

core digital systems like enterprise resource planning
(ERP) and document management systems (DMS), but
validation processes remain manual, and validation
data is poorly managed. Validation professionals have
been left to struggle with paper and spreadsheets —
creating an offline data gap. This digital disconnect
jeopardizes data integrity and compliance and slows
collaboration, production, and product release.

Paper-based validation poses a challenge to any

company. It’s unreliable, inconsistent, inefficient,
and stifles innovation. Unfortunately, paper-based
validation has been baked into standard operating
procedures for decades. Convincing stakeholders to
ditch paper may take real effort. The conversations
outlined here will help you overcome common hurdles
to digitizing validation.

How to Calculate the ROI of Digitized Validation 3

Build Your
Business Case
#1. H
 ow to obtain a commitment
from leadership
Getting executive buy-in is essential for any IT investment.
Focusing on these three points when engaging with
leadership will demonstrate that digital validation is worth
the time and resources.

Better decision-making. It’s too easy for companies to

print validation documentation, store it, and forget about
it until it’s time for an audit. Automating validation through
digitization allows for the creation of a living document
that empowers business leaders to identify and remove
bottlenecks in real time. More importantly, this access to
data and insight enables more informed decision-making
through the product development lifecycle, enabling
leaders to take proactive steps instead of reacting to a
document based on data that’s weeks (or months) old.

Fast ROI. Companies can expect efficiency gains of 50%

or more throughout the validation lifecycle. Activities
that support validation, such as tracking status, planning
for audits, and allocating validation resources, see a 70%
efficiency improvement — and sometimes even more.
All told, digital workflows cut the timeline for validation
processes in half. As validation makes up 20% of product
development, digital validation cuts the timeline and cost
of product development by 10%. The return on investment
will compound project after project. We’ll dive deeper into
this in the second half.

Support the move to Pharma 4.0. As described by ISPE,

As validation makes up 20% of product
the Pharma 4.0 operating model represents the push to
development, digital validation cuts the
embed digitization and automation into pharmaceutical
timeline and cost of product development by
product development in a similar manner to traditional
10%. The return on investment will compound
manufacturing processes. If pharma companies aim
project after project.
to transition to Pharma 4.0 — and gain a significant
competitive advantage — they can’t do it with a paper-
based validation process.

4 How to Calculate the ROI of Digitized Validation

#2. H
 ow to articulate benefits to Quality assurance benefits from an enforced standardized
process, which results in more consistent reviews
business lines regardless of which internal and external stakeholders
contribute to the effort. QA teams can also spend less
Business unit leaders will benefit from seeing how their time on the minutia and more time reviewing the technical
workflows improve the performance of the teams they controls that impact product quality and compliance.
manage. Use the following discussion points to lead
conversations with department heads. Manufacturing and IT dramatically improve efficiency
through digitization. Electronic workflows for creating
Validation teams gain access to a traceability matrix and approving validation plans, generating traceability
that’s generated and maintained in real time. This allows matrices, executing validation protocols, conducting risk
validation to happen in a much more agile manner assessments, maintaining revalidation schedules, and
throughout the product development lifecycle. It also other tasks can lead to efficiency gains of 50% or more.
enables teams to identify and mitigate issues before they
pose a substantial risk to the product.

How to Calculate the ROI of Digitized Validation 5

#3. How to emphasize the existing Continuous validation. Traditional validation spends
high effort on the initial project. Revalidation is resisted
precedent for automation  because that initial validation required too much time and
effort. Automation allows validation to occur continuously
Does digitizing validation represent a significant change for throughout the development lifecycle — in minutes instead
life sciences companies? Yes. However, it’s also true that of months.
other business units have already embraced automation.
Highlight how these departments have benefited from Up-to-date traceability. Likewise, automation enables
agile and digital workflows to show that the learning curve dynamic traceability matrices throughout software
doesn’t need to be steep. development and validation. Matrices are updated in real
time, creating a living document, instead of reconstructing
DevOps leverages autonomous maintenance and them at the end of the project. These matrices are then
monitoring to enable continuous delivery and incremental instantly available during an audit.
improvement of software products. Manual processes for
maintenance and monitoring impede productivity, making Issue resolution. Real-time validation identifies and
agile software development nearly impossible. prioritizes issues with a software product. One obvious
benefit is fixing bugs as they arise. Another benefit is the
Security uses continuous threat monitoring and automated ability to flag issues likely to cause downstream trouble.
remediation to identify and respond to far more cyber This lets engineers address these problems in the moment
security threats than individual security analysts could before they require significant and time-consuming
find using manual steps. rewrites to the application.

Quality assurance automates the software testing process Process transformation. One of the biggest dangers
into a routine throughout the development lifecycle. Bugs of digitizing a manual process is bringing along the
and performance issues can be fixed in real time, long inefficiencies of working with paper, whether it’s data
before they impact additional features downstream. entry, version control, or communication with reviewers.
Automating these aspects of validation transforms
them into highly streamlined processes that occur in the
background so reviewers can focus on tasks that require

#4. How to demonstrate the their full attention.

potential for proactive New standard operating procedures. Paper-based

decision-making validation workflows have remained in place for so long

because they’ve been the de facto standard operating
procedure. The efficiencies and savings associated
It’s difficult for decision-making based on paper
with digitized validation, from planning and tracking to
documentation to be anything but reactive. In the mere
execution and maintenance, allow companies to rewrite
minutes it takes to print a validation document, an
the SOPs for validation once and for all.
engineering team can execute large-scale changes to
the application being validated, rendering the printed
document obsolete. One of the biggest benefits of
digitization is that it enables validation to shift from a One of the biggest benefits of digitization
retrospective process to one that’s more proactive and is that it enables validation to shift from a
prescriptive. Highlight: retrospective process to one that’s more
proactive and prescriptive.

6 How to Calculate the ROI of Digitized Validation

Real Customers
Real ROI
When it comes to investing in a new software system, it’s
Validation Activity Breakdown
all about ROI. Not features. Not even benefits. Executives
want to know: How much do I get out of this investment
— and how fast? To find out, we surveyed ValGenesis 5% Creating, reviewing, and approving
customers about their validation processes before and validation plans and projects
after implementing the ValGenesis VLMS. The goal was
to determine the savings and efficiency gains customers 25% 
Authoring, reviewing, and approving
realized from digitizing both their core and supporting validation protocols
validation activities with ValGenesis.

10% 
Creating and maintaining traceability
While every company is unique, the data shows that digital
matrices and requirements
validation is a giant leap forward in efficiency; it can
reduce the time it takes to complete validation projects by
50% or more. 25% 
E xecuting, reviewing, and approving
validation protocols

While every company is unique, the data shows 10% Performing, reviewing, and approving
that digital validation is a giant leap forward risk assessments
5% Creating and maintaining periodic
in efficiency; it can reduce the time it takes to
reviews and revalidation schedules
complete validation projects by 50% or more.
20% 
Supporting validation activities

How to Calculate the ROI of Digitized Validation 7

The chart below takes you through the manual processes and challenges associated with
each core validation activity and the efficiency gains you can expect when you automate with
ValGenesis.

Efficiency
Paper-Based Process ValGenesis Process
Gain

Creating, reviewing, and approving validation plans and projects:

1.1 20 – 30%
5% of the effort in the validation lifecycle process

1.1.1 Manually create validation plans and Electronically create validation plans and
projects, then route them for review and projects, then route them for review and
approval through interoffice mail. approval through an automated electronic
workflow.
Approved validation plans are available as a
reference and may not effectively control the Approved validation plans and requirements
process due to their paper-based nature. can be enforced in the process and eliminate
the risk of excursion from the plan,
preventing noncompliance.

Authoring, reviewing, and approving validation protocols:

1.2 20 – 30%
25% of the effort in the validation lifecycle process

1.2.1 After a protocol is authored or executed, it is After a document is authored in ValGenesis,

physically routed to reviewers or approvers the authored document is routed
through interoffice mail or other delivery electronically and is available for review and
options. approval in real time. ValGenesis supports
sequential, simultaneous, and hybrid
Documents may be lost in the routing
workflows for reviews and approvals to
process or languish on someone’s desk.
expedite the final approval process. Every
Physically routing documents from one document, history, and current status is
location to the next adds additional delays, available electronically, ensuring document
as typically, the approval process requires control.
sequential review and approval.
Documents can be reviewed in parallel,
whereby all reviewers can review the
document simultaneously.

1.2.2 There is no automated way to alert reviewers Reviewers are alerted in real time via alert
and approvers to target dates and/or delays notification to any review or approval task
in the process. It is difficult to transfer tasks through corporate email.
to different reviewers and approvers in the
event of a delay.

1.2.3 Physical access to the document is required No physical access is required. Documents
to review and approve the paper document. can be accessed securely through corporate
Review and approval get delayed if the intranets or networks.
reviewer and approver are not physically
present.

8 How to Calculate the ROI of Digitized Validation

 Efficiency
# Paper-Based Process ValGenesis Process
Gain

Creating and maintaining traceability matrices and requirements:

1.3 40 – 50%
10% of the effort in the validation lifecycle process

1.3.1 Creating and maintaining traceability The traceability matrix function within
matrices through a manual process is a time- ValGenesis improves change management by
consuming task. The traceability of the test accurately assessing its impact by identifying
cases to the requirements may be buried in related requirements, design elements,
the paper-based documentation and may not and test scripts. It also helps to scope the
provide any real-time information at the time regression testing clearly and accurately.
of tracing, making it challenging to assess
During test case execution, the deviations
the change impact.
observed in a test case can be tracked
and traced back to the associated design
elements in the traceability matrix.

During audits and inspections, the

traceability matrix provides a clear, real-time
view of the requirements and test coverages
based on the risk level.

1.3.2 Coordinating the development of ValGenesis brings users together through

requirements with all users takes significant collaboration, effectively reducing the time
time. to complete the requirement-gathering
process.
Requirements are subject to frequent
changes, making it time-consuming and
challenging to maintain them using a paper-
based process.

Executing, reviewing, and approving validation protocols:

1.4 40 – 50%
25% of the effort in the validation lifecycle process

1.4.1 Documents must be executed manually Documents are executed electronically using
using a pen and an approved paper protocol. a tablet, laptop, or desktop, and screenshots
Screenshots and supporting files like reports are attached at the test-case-row level with
must be printed and subsequently attached a single click. Screenshots are captured with
within the document being executed as a complete audit trail and watermark at the
attachments. test-step level. Additional supporting files
can be attached at the row level.

1.4.2 Deviations or exceptions are handled Deviations are handled electronically, and
manually using paper-based documentation. the deviation workflows are concurrent for
Each deviation is taken through a separate, any number of deviations, expediting the
time-consuming paper-based workflow. execution process.

How to Calculate the ROI of Digitized Validation 9

 Efficiency
Paper-Based Process ValGenesis Process
Gain

1.4.3 During the test case execution, handwritten ValGenesis provides spell-checking, and all
results can be challenging to read and may content is digitized, legible, human readable,
contain spelling and grammatical errors. and readily accessible.

1.4.5 Once the document has been executed, it In ValGenesis, executed documents are
must be physically sent to the corresponding routed electronically and available for review
reviewers and approvers through interoffice and approval in real time.
mail or other delivery options.
The system supports simultaneous (parallel),
Routing documents from one location to the sequential (serial), and hybrid (a combination
next adds additional delays, as typically, an of simultaneous and sequential) reviews
approval process requires sequential review and approvals to expedite the final approval
and approval. This process flow creates process.
obvious inefficiencies.
ValGenesis supports the reuse of
requirements and developed protocols
through binding and linking processes to
other similar systems to be validated across
the organization.

1.4.6 There is no automated way to alert reviewers Reviewers are alerted in real time via alert
and approvers to target dates and/or delays notification to any review or approval task
in the process. through corporate email. Tasks may be
transferred to other reviewers and approvers
automatically (using a compliant process) in
case of delay.

Management is notified of delays and can

take action to remove barriers as required.

1.4.7 Physical access to the executed document No physical access is required; documents
is required to review or approve the are approved through secure networks.
document. Review or approval gets delayed
if the reviewer or approver is not physically
present.

1.4.8 There is a potential to misplace or lose the Documents are available in electronic format
executed document during transfers. and stored centrally for secure, easy access.

10 How to Calculate the ROI of Digitized Validation

 Efficiency
Paper-Based Process ValGenesis Process
Gain

Performing, reviewing, and approving risk assessments:

1.5 40 – 50%
10% of the effort in the validation lifecycle process

1.5.1 Risk assessment is done manually at the All the required stakeholders collaboratively
system or requirement/functional level and perform risk assessment at the system or
requires feedback from various stakeholders. requirement/functional level.
Collaborating effectively with all the
Risk assessment results are linked with
stakeholders is challenging.
testing, validation, change management,
Risk assessment results are maintained as a and periodic review activities.
separate document without a direct link to
the testing, validation, change managment,
or periodic review activities.

1.5.2 Risk assessments are approved manually, Risk assessments are approved through
which is time-consuming. a comprehensive electronic workflow.

Creating and maintaining periodic review and revalidation schedules:

1.6 40 – 50%
5% of the effort in the validation lifecycle process

1.6.1 Periodic review and revalidation schedules ValGenesis provides a dynamic validation
are maintained in paper format or Excel. This calendar for upcoming periodic reviews and
process is time-consuming and error-prone. revalidations, preventing possible delays.

The system alerts the appropriate user

groups if there is a delay with a periodic
review task for any GxP system or process to
eliminate human errors in the revalidation
program.

1.6.2 Periodic review and revalidation schedules Periodic review and revalidation schedules
are approved manually. are approved through electronic workflows.

1.6.3 There is no automated way to alert users to Users receive notification alerts for
upcoming periodic reviews or revalidations. upcoming periodic reviews and revalidations.
This prevents the possibility of delays and
missed tasks.

Supporting Validation Activities Here is the breakdown:

• Tracking the validation status: 10%

Four supporting activities account for 20% of a • Audit preparation for internal and external audits: 3%
company’s corporate validation efforts. • Document retrieval: 2%
• Tracking validation metrics for resource and budget
planning: 5%

How to Calculate the ROI of Digitized Validation 11

 Efficiency
Paper-Based Process ValGenesis Process
Gain

Tracking the validation status:

2.1 70 – 80%
10% of the effort in the validation lifecycle process

2.1.1 Tracking the validation status is complicated, ValGenesis' built-in tracking functions allow
as it often requires email or phone calls users to locate an authored or executed
to prospective reviewers, approvers, and document easily and in real time. These
document specialists. functions include developing and executing
pie charts from the dashboard, an inventory
manager with search capabilities, barcode
scanning from the production floor, and
transparent audit trails available to any user
involved in developing, executing, reviewing,
or approving any document.

Audit preparation for internal and external audits:

2.2 80 – 90%
3% of the effort in the validation lifecycle process

2.2.1 Documents are often stored in bulky Documents are generated electronically with
binders in an off-site repository. Locating, audit trails and can be retrieved from the
assembling, and transporting paper system's electronic document repository
documents is a massive burden, especially easily, in real time. When audits occur, data
when preparing for an audit or inspection. is already organized, stored, and readily
available with minimal prep work.

Document retrieval:
2.3 70 – 80%
2% of the effort in the validation lifecycle process

2.3.1 Paper-based document search and retrieval With information digitized, indexed, and
methods are painfully slow and often require centralized, document searching is near-
users to travel to an off-site repository. instant. There is also the added benefit
What’s more, creating and maintaining a of mobility. Users can search and retrieve
competent paper-based archive requires documents from multiple sites without being
significant effort and work hours. physically on-site.

Tracking validation metrics for resource and budget planning:

2.4 50 – 60%
5% of the effort in the validation lifecycle process

2.4.1 Metrics are not available in a paper-based ValGenesis provides metrics for budgeted vs.
system, making it challenging to control actual results for efficient planning and cost
project costs and estimate budgets. control.

2.4.2 There is no mechanism to track the individual ValGenesis tracks the performance
performance of users involved in the of individual users within the system.
validation process.

12 How to Calculate the ROI of Digitized Validation

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.

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