Quality Assurance

Enhancing your lab with validated, compliant, and reliable software.

Validation Verification

We have over 25 years of experience devoted to designing and revamping our software development lifecycle and program testing.

You can choose between two validation packages to meet your QA requirements and additional documentation is available on request.

Validation Package

IQ/OQ Validation Package

The IQ/OQ Validation Package is tailored for laboratories requiring installation and operational qualification, ensuring your Freezerworks system functions correctly and complies with regulatory standards. Key features include:

  • Test Script Templates: Pre-constructed scripts tailored for IQ (Installation Qualification) and OQ (Operational Qualification).

  • Basic Laboratory Configuration: Scripts designed to test core Freezerworks functionalities in standard lab setups.

  • Comprehensive Testing: Coverage of metadata, security features, and functional testing across all system aspects.

  • Audit-Ready Documentation: Support for regulatory compliance and audit preparation.

Our Validation Practices

Validation Verification

Our Validation Verification is ideal for laboratories requiring documentation to demonstrate compliance and reliability. This process includes:

  • Software Development Lifecycle (SDLC) Validation: Detailed records of our software validation process.

  • Module Testing: Validation of Freezerworks modules using test scripts.

  • Completion Tracking: Validation progress is tracked by round and documented in organized spreadsheets.

  • Test Script Samples: Examples of completed test script pages.

  • Certificate of Validation: Official proof of compliance with industry standards.

Software Validation & The FDA

To learn more, watch Part 1 and Part 2 of our series on software validation, the FDA, and Freezerworks below.

Additional Resources

Curious about our license?

Review the terms of use and licensing details for Freezerworks software by accessing the Freezerworks License Agreement below.

Looking for additional QA resources?

Explore our library of downloadable resources to keep your lab compliant, including validation reports, manuals, and more.

Additional information

  • Freezerworks products do not currently conform to Federal Information Processing Standard 140-2 (FIPS 140-2). Freezerworks data is stored solely in a database, but the database is not encrypted unless the system administrator enables database encryption at the server level. User names and passwords are automatically encrypted by the program, but the encryption scheme does not meet FIPS standards. Dataworks is investigating changing the encryption scheme in future versions.

    Freezerworks software does not use cryptographic modules with firmware components for data storage and transmission as described in the Security Level 1 of FIPS 140-2, nor does Freezerworks interact with any physical security mechanisms as described in Security Levels 2-4.

  • In alignment with the Health Insurance Portability and Accountability Act of 1996 and the HIPAA Omnibus Final Rule of 2013, Dataworks Development has continued to strive toward providing products that assist customers in their efforts to protect patient’s privacy.

    Read more about Freezerworks and HIPAA.

  • The following Voluntary Product Accessibility Template (VPAT) document describes how Freezerworks’® features address the accessibility standards described in Section 508 of the Rehabilitation Act.

    Read more about Freezerworks and Section 508.

  • Looking for software validation guidance?

    Visit the FDA website for more information.