The Cockpit Validation Kit
Software solutions – electronic record systems – for product development should be validated during:
Cockpit’s Validation Kit allows your team to spend more time on core competencies than on validating third-party software solutions.
The Validation Kit makes validation efforts faster and compliance requirements easier the first time around. Your organization can continue benefiting from the validation results and documentation from the beginning and throughout every release, allowing you to validate changes to Cockpit with minimal disruption.
Supported standards, regulations and guidance
The Cockpit Validation Kit meets the following standards, regulations, and guidance:
Features & benefits
Complete out-of-the-box validation report
Cockpit users save time by not needing to validate the platform in its out-of-box state.
The Cockpit Validation Kit simplifies the addition of configurations to the existing validation plan with support from Cognition.
Comprehensive validation documentation including: test plans, protocols, requirements, and execution records all with traceability and reports to submit as evidence of software validation
Cost reduction – the Cockpit Validation Kit reduces time and expense traditionally devoted to developing, writing, and executing validation testing. Organizations can move faster towards regulatory compliance.
Updated validation documentation within the Cockpit Validation Kit with each Cockpit release
Each Cockpit release provides Validation Kit users with a full, updated documentation set, reducing time needed to complete validation efforts.
21 CFR Part 11
The out-of-box Cockpit Validation Kit supports validation of electronic signatures and records.
Synergio’s Validation Subject Matter Experts (SMEs) create, run, and maintain your validation environment.
Ongoing validation support
Synergio’s Validation SMEs are available to assist, support and advise our customers, not only with the initial installation but also throughout the design stages. As part of our services, we work with outside agencies if necessary.
Cockpit's Software-as-a-Service (SaaS)
Cockpit’s Software-as-a-Service (SaaS) environment empowers validation for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) based on AAMI standards:
- IQ — Ensure Cockpit is installed and operating as intended (Synergio validates Cockpit against pre-defined sets of intended use protocols)
- OQ — Verify that Cockpit functions properly under normal/abnormal conditions and at limits of intended operation
- PQ — Determine repeatability of software functions in the environment by intended users (where applicable)
Synergio will provide support for IQ, OQ, and (where applicable) PQ testing.