Dataworks Development, Inc. has more than 25 years of experience devoted to designing and revamping its Software Development Lifecycle, which includes program testing. When requested, we provide documentation of this validation to our customers as a means for them to measure our internal dedication to quality product design.
We offer two validation packages to help you meet your QA requirements:
The Validation Verification Package contains the following items for your examination:
- Software development lifecycle (SDLC) validation process
- Freezerworks modules validated in the test scripts
- Validation completion by round, spreadsheet
- Samples of completed test script pages
- Certificate of Validation
Final documentation of the test scripts, above, encompasses approximately 6000 printed pages. For ease of review, selected representative samples of pages have been provided.
The IQ/OQ validation package is a set of test script templates to be used with Freezerworks for installation and operational qualification validation. These scripts are constructed with a basic laboratory configuration that covers a wide range of metadata and security level testing across each functional feature of Freezerworks.
Run the scripts as-is or modify them to meet other requirements that may be mandated by your institution. The executed scripts will provide a complete set of documented evidence of your Installation and Operational validation procedures for audit purposes.
- Certificate of Validation for Freezerworks 2022 13.01.01
- Validation Verification Package for Freezerworks 2022 13.01.00
- Validation Verification Package for Freezerworks 2021 12.0.02
- Validation Verification Package for Freezerworks 2021 12.0.00
- Certificate of Validation for Freezerworks 2019 11.01.00
- Certificate of Validation for Freezerworks 2019 11.0.00
- Certificate of Validation for Freezerworks 2018
- Certificate of Validation for Freezerworks 2017
- Certificate of Validation for Freezerworks 2015
- Freezerworks Assists with Security Standards
- Section 508 VPAT for Freezerwork
- General Principles of Software Validation: Final Guidance for Industry and FDA Staff
- 21 CFR Part 11 Compliance
- Federal Information Processing Standard (FIPS 140-2)
Here is our Freezerworks License.