There is no one-size-fits-all solution to complying 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 quality standards 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.
Intland’s Tool Validation Kit
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 ALM for your use case. Expedite tool qualification and compliance during the development of:
- automotive systems (ISO 26262, IEC 61508, Automotive SPICE)
- medical devices (IEC 62304, ISO 14971, ISO 13485, IEC 60601, FDA Title 21 CFR Part 11)
- aviation embedded systems (DO-178C and DO-254)
- pharmaceutical products (GAMP® 5)
Intland’s Tool Validation Kit comes with:
- Manual and automated test configurations, test cases, and test sets
- The most common use cases for verification
- Test cycles, manual and automated test runs.
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.
Title 21 CFR Part 11 Validation Kit
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 ALM.
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 ALM can be fully validated against FDA Title 21 CFR Part 11 as applicable to systems maintaining electronic records.
codeBeamer ALM supports:
- Document export: Flexibility around exporting documents, including MS Word, Excel, or PDF export.
- Baselining: Create immutable snapshots of specifications and accompanying documents at the time reports are created.
- Electronic signatures: Apply e-signatures integrated into workflows, or via the Review Hub. Electronic signatures are timestamped, human readable, and may be exported into electronic records.
- Audit Trail Reporting: A timestamped, computer-generated log of all Audit Trail activities may be simply created to comply with FDA or other international requirements.
This 21CFR11 Validation Kit helps qualify codeBeamer ALM 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.