Risk based Application Lifecycle Management.
Seamlessly manage your Requirements or User Stories including their own hierarchy and versions.
Systems and Requirements Risk Assessment. Different models allow flexibility in terms of Risk priority levels and also Risk Detectability.
Automated and Manual Testing all in one tool.
Ability to use for both Structured and Session Based testing. Works across any application, browser and platform.
Risk based Defect Management and
Defect Tracking throughout the Application lifecycle.
Real time trace view showing the link between Requirements, Test Scripts and Defects throughout the whole validation lifecycle.
Paper and manual based validation is both time consuming and document intensive.
Using Electronic Records and Signatures has the potential to reduce this time and effort.
Management of Requirements/User Stories is critical to the success of any project. Our solution is designed to capture and manage the information associated with Requirements/User Stories and their associated risk throughout the testing validation life cycle.
ProcedureCapture allows you to :
ProcedureCapture® can both capture Test scripts in your actual software environment and also create manual Test scripts for Process Validation.
Executing a Test Script
Risk Based Priority Defect Management - traces the Defect risk priority back though the Tests and back to the Requirements.
Defect tracking – allows the complete tracking of a Defect throughout its lifecycle.
A matrix that maps user Requirements to Test scripts and then to Defects is one of the key deliverables in any validation life cycle. The matrix is an effective and visible way of determining this traceability and is key in understanding how everything hangs together in the lifecycle.
The matrix is also an important tool during an audit as it demonstrates that appropriate validation tests have been conducted. Most auditors would use the matrix as a basis for investigating and then check the protocols to verify that the tests have been performed.The ProcedureCapture trace matrix is Automatically generated from the script properties and the separate trace grids can be viewed and exported. ProcedureCapture then uses your actual SOP Word Templates to generate the following Trace Matrices documentation reports.
Validation can require a high degree of manual effort for tracking and reporting, and the execution of most validation protocols takes place on paper.
Paper and manual based validation can be both time consuming and document intensive and may compromise a life science firm’s ability to bring products to the market on time.
Using Electronic Records and Signatures has the potential to reduce this time and effort and ProcedureCapture allows you to reuse the same test script assets that have been created for paper execution. All created assets are therefore "electronic signature ready".
ProcedureCapture allows you to
Post Execution Approval
ProcedureCapture is fully 21 CFR Part 11 compliant, with rich security features enabling a great level of control over the documentation created within the system and around users of the system as well.
ProcedureCapture covers Requirements, Risk, Testing, Traceability and Defects with no add ons.
All from one integrated, affordable and easy to use tool.