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