There is no silver bullet for compliance with international safety-critical regulations on tool validation and on the management of electronic records and e-signatures. Companies with tailor-made operational processes and unique internal regulations need to find their own ways of ensuring regulatory compliance.
Intland’s Validation Kits help you reduce the time and effort costs of proving adherence to regulatory requirements.
Demonstrate that your ALM tool is fit for use in its intended purposes as a software development tool. Use Intland’s Tool Validation Kit to significantly cut audit costs and increase confidence in the maturity of your development activities!
This kit contains all the assets (use cases as well as related manual and automated test cases) that you or any independent auditor needs to accelerate the qualification of codebeamer or codebeamer X for your use case. Expedite tool qualification and compliance during the development of:
Intland’s Tool Validation Kit comes with:
Intland’s Tool Validation Kit may require some customization to match your use case, environment, and other specific characteristics of audited processes. For pricing info on customization, please visit our pricing page or contact sales.
Yes, we have Validation Kits to support tool qualification for codebeamer‘s LTS (long-term supported) versions, and for Intland Retina 3.1 (now called codebeamer X).
No, we don’t offer an evaluation version for these kits.
These Validation Kits include automated and manual test cases for a high number of use cases of our platforms. We don’t offer free access to these Kits, but we do provide validation consulting services to support your validation process.
These Kits contain hundreds of test cases and automated tests for relevant use cases of our platforms. When conducting a tool validation process, you’ll map out your use cases and run relevant testing to verify the correct functioning of our products. Have special and customized use cases? We offer customization services to support your validation efforts, and we can also add those custom use cases to the Kit to enable you to complete validation for your custom version.
In regulated industries, various standards (ISO, IEC, and FDA) and guidelines call for the qualification of (COTS and other) software tools used in product development. For more information on tool validation, talk to your QA department, or book our consulting services.
Please feel free to get in touch with us if you need more information about our Validation Kits or the validation consulting services we offer.
Intland Software’s FDA Title 21 CFR Part 11 Validation Kit helps our medical and pharma users access best practices for complying with electronic record and e-signature regulations when using codebeamer.
In the handling of electronic records, FDA has a very narrow description of cases where 21 CFR Part 11 applies. As per the regulation, the system supporting electronic records needs to be validated, audit trails have to be created, record retention managed, and record copying rules need to be defined.
This Validation Kit significantly reduces the time and effort investment of validating your computer system maintaining electronic records. The kit provides a great starting point for your validation activities, saving you a great deal of costs, internal resources, and man hours.
Intland Software’s codebeamer can be fully validated against FDA Title 21 CFR Part 11 as applicable to systems maintaining electronic records.
codebeamer supports:
This 21CFR11 Validation Kit helps qualify codebeamer against relevant FDA regulations. The Validation Kit comes packaged with domain-oriented consulting and customization services in order to help you understand and implement its application for your use case or defined SOP.
For pricing information, please visit our pricing page or contact sales.
Any questions? Don’t hesitate to reach out! We try to respond to all inquiries within one business day.
