Hello, FreeQMS community!

It's been nearly three years since FreeQMS joined the web to share our knowledge about quality management. In this time, we've created over 40 videos, accumulated 100,000+ views, and reached many people in the quality field.

Today, we're thrilled to discuss the 2023 Release Validations and their impact on FreeQMS. Specifically, we'll focus on the shared features validation, highlighting changes from 2022 to 2023.

Shared Features Validation

The shared features validation is a comprehensive examination of common elements across all FreeQMS modules. These include links, uploads, and record creation, ensuring a seamless experience throughout the system.

The 2023 Changes

Let's dive into the notable changes in the 2023 shared features validation and their real-world implications:

1. Year Change (2023): The 2023 validation accounts for the new year, making all notes written during the validation process distinguishable with '2023.'

2. Language Tweaks: We've made small language adjustments, removing "implemented" to emphasize immediate usability of FreeQMS modules.

3. Validating User and Environment: Responding to user feedback, we now emphasize the system's compatibility with older browser versions, ensuring flexibility and functionality for all users.

4. Record Creation: The 2022 validation scripts created records in the live environment, whereas the 2023 scripts establish a separate validation division, similar to a demo environment. This shift streamlines the validation process.

5. Clarifications: Test Procedure and Acceptance Criteria sections include language clarifications, enhancing clarity for users.

6. User Executable Scripts: Section 9 Requirements and Tests now highlight the need to create a validation division and input '2023' when making notes.

7. Enhanced 21 CFR Part 11 Compliance: Sections 9.7 and 9.8 introduce the inclusion of user names and login email addresses on timestamps, contributing to enhanced 21 CFR Part 11 compliance.

User-Focused Protocols

Now, let's explore the changes that matter most to users and companies considering revalidation:

8. Test Prerequisites: The creation of a validation division is a significant addition, improving organization and alignment with the live environment.

9. Configuration of Dummy Users: Test 1 guides users in configuring dummy or test users for access to the validation division.

10. Language Consistency: Minor language changes ensure uniformity, enhancing the user experience.

11. Test Files Naming: The naming convention for test files now includes the complete "dummy" name with a file extension, making file management more intuitive.

12. File Expiration Date: Users are advised to set tomorrow's date for expiration, avoiding immediate expiration reports.

Streamlined Configuration

Moving on to Test 2, we see the creation of VALIDATION supplier 4. The standardized approach simplifies system navigation and documentation.

Expanded Scope: Users can now describe supplier-related risks and list products or services, further improving documentation and risk management.

Test 3 examines the presence of delete buttons in FreeQMS tabs. The addition of new tabs in 2023 ensures the system keeps pace with evolving user needs.

System Links and Audits: Test 4 evaluates system links across modules, while changes in audit records aim to enhance compliance with 21 CFR Part 11.

Efficient File Management: Test 5 addresses the ability to upload files, streamlining file naming and expiration, making file management easier.

Enhanced Task Resolution: Test 6 reflects the addition of the task resolution field, improving validation performance.

Approval Cycle: The approval system remains largely unchanged, with minor adjustments to the user interface, making it easier to select and remove approvers.

Final Evaluation: The validation process concludes by examining approval cycles and closing records.

We hope this video helps quality departments considering re-validation. Thank you for joining us, and we look forward to sharing more updates and improvements in 2024 when the next round of validations is released.

Stay tuned for more insights, tutorials, and updates from FreeQMS.