e-Validation – Establish a Plan for a Paperless Validation Environment Ty Mew Ofni Systems Inc.
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e-Validation – Establish a Plan for a
Paperless Validation Environment
Ty Mew
Ofni Systems Inc.
About Ty MewTy is the President and founder of Ofni Systems Inc.
He has worked for 100’s of FDA-regulated companies
as well as the FDA themselves, conducted over 500
21 CFR Part 11 Audits, and is the creator of both the
ExcelSafe and FastVal software applications.
AMA!
Total Number of Paper-Based Validations Performed in the Last 10 Years
1(and it’s a funny story)
Some Common VMS Systems
FastVal*
Kneat
*Disclaimer – We wrote this.
Top Benefits of Using Paperless Validation
• Reduce time required for validation projects by 70%
• Integrates into your quality systems and validation process
• Tracks and reports your validation project status
• Built-in Project Management Tools and Reporting
• Validation Project Metrics to gain valuable insight into your
validation activities
• Fully 21 CFR Part 11 compliant with Audit Trails, Electronic
Signatures and tools for Paperless Protocol Execution
Paperless Validation Driving Forces• Financial/Budget/Cost-savings
• Regulatory/Audit Compliance
• Process/Product Improvement
• Quality Assurance
Financial/Budget/Cost-savings• Spend less money on validation
• Faster validation less time to market
• Control employee/contractor cost
Regulatory/Audit Compliance• Audit Proof Documentation
• Meets all validation requirements
• “FDA Audit-Proof” Validation Documentation
• Compliance with Part 11, Annex 11, CDISC, GAMP 5,
and many other regulations
FDAAUDITPROOF
Process/Product Improvement• Reduce validation time
• Better testing
• “There must be a better way to do this!’
• 100% control over document structure, control &
format
• Project Management Tools
Quality Assurance• Matching existing documentation standards
• Reduce doc review time
• QA checks to catch common mistakes
Your Biggest Challenge Answer the following question
What do I want to cut
from my existing validation tasks?
Document TemplatesPaperless validation allows
you to generate any
document required by your
validation process.
Validation document
content and formatting can
be configured to match
your existing templates.
Documents can include
pictures, tables, or
embedded PDF content.
Documents can also include
comments to facilitate the
review process.
MS Word Templates
You have 100%
control over the
structure, content
and format of any
document that is
exported to MS Word
Enforce Documentation Standards
Verification of Completed Test Case StepsWhen the protocol is executed, the person performing the test follows
the test steps. After following the test steps, the person executing the
protocol records what happened in the Actual Results column of the
protocol.
Follow Test Instructions outlined in Procedure. Following the Test
Instructions should produce the results outlined in the Expected Results
field.
When Actual Results do not match expected results, mark the test step
as Failed and initiate a deviation. If a test step fails, it will automatically
open the Deviation screen.
Ability to Automate Documentation Paperless validation allows for
modules which provide
additional analysis tools to
facilitate the validation of
specific types of software
applications.
Spreadsheet Wizards –
Provides additional tools to
analyze MS Excel
spreadsheets, including
identifying workbook
elements, spreadsheet
formulas and automatically
generating test cases.
Wizards for Databases &
Web-Based Applications are
also available .
Pre-Written Test CasesPaperless validation systems allow 100’s of popular test case templates for creating
test protocols quickly and accurately.
New test case templates can be created quickly for immediate use in the current
project, and can be saved in the common libraries for others to use in any future
validation projects.
Summary Report Wizard
After protocol execution,
paperless validation allows
for automatically generated
Validation Summary reports,
including a summary of each
test case and the deviations
generated during protocol
execution.
Automatic Requirements Trace MatrixPaperless validation allows for
automatically generated
Requirements Traceability Matrix
for all projects. When project
requirements are defined, the
software automatically begins
generating the link between system
requirements and corresponding
test cases.
Any gaps in the automatic
traceability matrix are clearly
displayed, both on the appropriate
requirement and on the first page
of the report. The traceability
matrix updates automatically, even
if the documents are edited.
Automatic Change Control Tracking
Software tracks all changes
made during document
revision and summarizes
document changes in
Change Control reports.
Track re-validations and
program revisions. Retest
only requirements which
have been changed.
21 CFR Part 11 Compliant
Paperless validation should be fully compliant with 21 CFR Part 11, including audit
trails and electronic signatures.
Once documents are signed, they are locked from further changes.
21 CFR Part 11 Compliant Audit Trails
Audit trails are used everywhere
in paperless validation, but are
especially important in protocol
execution!
One of the standard reports we
create for each executed protocol
is a complete history of every
change made in each step during
execution. These will line up
perfectly with the automatic date
and time captions on the
screenshots, resulting in a very
defendable validation project!
Automatic Screen Capture Tools
Screenshots can be collected for any step to document any activities or results. All
screenshots are automatically saved for inclusion in the executed protocol, and are
date and time stamped along with additional information about the test environment.
Paperless Protocol ExecutionPaperless validation allows users to
execute validation protocols electronically.
As with paper-based protocol execution,
testers follow the defined procedure and
view the expected results of an approved
protocol.
Validation testing is documented with text
and screen captures. Screenshots are
embedded into the executed protocol along
with the Computer ID, User ID, and the date
& time of the screen shot.
Automatic Deviation Reporting Tools
Any deviations can automatically
generate a Deviation Report to allow
defect investigation and tracking through
resolution.
Deviations include a Risk Assessment to
clarify how serious each deviation is to
the system.
Automated Wizards help to document
common types of deviations, such as
• Tester Errors
• Script Errors
• Documentation Errors
Automatic Deviation TrackingSoftware can track all
deviations generated during
electronic protocol
execution. Software can
keep track of all deviations
for you.
Companies without an
existing CAPA system can
use software to track
deviations and ensure that
all deviations are
appropriately resolved.
Deviation Export OptionsSoftware can export deviations
to your existing CAPA system.
This allows companies with
existing CAPA systems to continue
to use those systems without
modifying their existing
procedures for deviation tracking
and resolution.
Deviations can also be exported to
your existing Deviation Reporting
Forms via MS Word Templates.
Deviations can be analyzed and
trended to identify common
failure points.
Full Details for the Current Project
Managers can view the status of any
document in real-time and provide public or
private comments throughout. Managers can
track and analyze data generated during
validation in real-time, including document
due dates, time to execute protocol steps,
and deviations generated during protocol
execution. Managers have access to an
extensive array of Project Management and
Metric Reports.
Live Estimates for Protocol Executions
Software can tell how long it
takes to execute test steps,
and can provide constant
updates about the expected
time until protocol execution
is completed.
Validation Status Update Reports
Time Tracking for Editing Documents
And the top benefit….
You don’t have to use as much paper…
Ty Mew
President
Ofni Systems Inc.
(919)844-2494
www.OfniSystems.com
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