e-validation Establish a Plan for a Paperless Validation Environment Ty Mew Ofni Systems Inc.

Transcription

1 e-validation Establish a Plan for a Paperless Validation Environment Ty Mew Ofni Systems Inc.

2 About Ty Mew Ty 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 CFR Part 11 Audits, and is the creator of both the ExcelSafe and FastVal software applications. AMA!

3 Total Number of Paper-Based Validations Performed in the Last 10 Years 1 (and it s a funny story)

4

5 Some Common VMS Systems FastVal* Kneat *Disclaimer We wrote this.

6 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

7 Paperless Validation Driving Forces Financial/Budget/Cost-savings Regulatory/Audit Compliance Process/Product Improvement Quality Assurance

8 Financial/Budget/Cost-savings Spend less money on validation Faster validation less time to market Control employee/contractor cost

9 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 FDA AUDIT PROOF

10 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

11 Quality Assurance Matching existing documentation standards Reduce doc review time QA checks to catch common mistakes

12 Your Biggest Challenge Answer the following question What do I want to cut from my existing validation tasks?

13 Document Templates Paperless 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.

14 MS Word Templates You have 100% control over the structure, content and format of any document that is exported to MS Word

15 Enforce Documentation Standards

16 Verification of Completed Test Case Steps When 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.

17 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.

18 Pre-Written Test Cases Paperless 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.

19 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.

20 Automatic Requirements Trace Matrix Paperless 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.

21 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.

22 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.

23 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!

24 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.

25 Paperless Protocol Execution Paperless 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.

26 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

27 Automatic Deviation Tracking Software 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.

28 Deviation Export Options Software 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.

29 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.

30 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.

31 Validation Status Update Reports

32 Time Tracking for Editing Documents

33 And the top benefit. You don t have to use as much paper

34 Ty Mew President Ofni Systems Inc. (919)