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ProcedureCapture®

Risk based Application Lifecycle Management.
ProcedureCapture® covers User Stories/Requirements, Risk, Testing, Traceability and Defects with no add ons.
All from one integrated, affordable and easy to use tool.

ProcedureCapture®

Risk based Application Lifecycle Management.

REQUIREMENTS
AND USER STORY
MANAGEMENT

Seamlessly manage your Requirements or User Stories including their own hierarchy and versions.

RISK ASSESSMENT

Systems and Requirements Risk Assessment. Different models allow flexibility in terms of Risk priority levels and also Risk Detectability.

TEST CREATION & EXECUTION

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.

DEFECTS

Risk based Defect  Management and 
Defect Tracking throughout the Application lifecycle.

TRACEABILITY

Real time trace view showing the link between Requirements, Test Scripts and Defects throughout the whole validation lifecycle.

ELECTRONIC SIGNATURES

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.

MANAGE REQUIREMENTS/USER STORIES

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 :

  • Create or import User, Functional and Design Requirements (URS, FRS & DS).
  • Create or import User Stories and link them to their related Acceptance Criteria.
  • Editable URS/FRS/DS grids with the ability to filter, group and sort Requirements.
  • Define the linkage and hierarchy between Requirements/User Stories.
  • Workflow control of Requirements and ability to require Electronic Signature for approval.
  • See real time traceability of your Requirements/Acceptance Criteria to Test Scripts throughout the project lifecycle.
  • Version control and complete history of each Requirement/User Story change.
  • Output your Requirement/User story  reports (including versions) throughout whole lifecycle.

RISK ASSESSMENT

ProcedureCapture's Risk assessment module includes the following :

  • Both System and Requirements Risk Assessment.
  • Different GAMP risk assessment models ?allows flexibility in terms of Risk priority levels and also Risk Detectability. Allows users to select which risk model they want to use by system.
  • Versioning the risk assessment, so that you can have a ‘before?and ‘after?risk assessment, showing what the risks are before mitigation/testing and after mitigation/testing.
  • Introduces hierarchy into Risk Requirements and allows you to define what values to use in your matrices if you have 1-1, 1-Many or Many to Many between User/Functional/Design.

From this Risk assessment, you can then ensure that the testing includes the necessary level of scope and correct degree of test rigor thus reflecting the risk level. This enables the level of testing detail to be appropriately scaled to the risk.

TEST SCRIPT CREATION & EXECUTION

ProcedureCapture® can both capture Test scripts in your actual software environment and also create manual Test scripts for Process Validation.

    Capturing a Test Script

    • Automatically capture a complete 'visual storyboard' of the test script.
    • Steps captured during Session Based testing can then be reused for Structured Testing.
    • Session Based Testing automatically produces overview report and video of complete test.
    • Follows the GxP testing guidance on "Supporting", "Proving" and "Non-Proving" step types.
    • Visual asset compelling as it is truly "understandable" amongst different stakeholders.
    • Fast, non-intrusive capturing technology which works on end-to-end procedures.
    • Works across any Application, Browser or Platform. 


    Executing a Test Script 

    • Manual and Automated Testing execution all within the one tool.
    • No programming required for any functionality.
    • Full audit trail of run results (including pass/fail reports and expected vs. actual screenshots).
    • Script properties auto inserted - UTR, Description, Creator, URS/FRS, Pre-requisites etc. 
    • ProcedureCapture runs the Test Script as if it is the end user. 
    • Fully 21 CFR Part 11 compliant, with security encoded features to protect signing information. 

    DEFECT MANAGEMENT AND TRACKING

    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.


    • Risk Based Priority Defect Management - traces the Defect risk priority back though the Tests and back to the Requirements which means you fix the most important defects first. 
    • Defect tracking ?allows the complete tracking of a Defect throughout its lifecycle and gives the whole team transparency of its status. 
    • Role-based Defects work flow - specific role is required for each Defect transition allowing the control and management of the process.    

    TRACEABILITY

    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.

    • URS (User Requirement Specification)
    • FRS (Functional Requirement Specification)
    • DS (Design Specifications)
    • Test Script Name & UTR
    • Defects

    ELECTRONIC SIGNATURES

    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

    • Electronically sign and countersign both approvals and validated outputs. 
    • Enables a 100% paperless validation process.
    • Electronic Validation process meeting FDA 21 CFR Part 11 compliance requirements.
    • Globalizes the Validation process and leverages the resources across the sites.

    Pre Approval.

    • Follow and review the Test Script in 'Movie' or "Real run" mode on the screen. 
    • Approve the script and electronically sign the approval. 
    • Test script is 'locked' and cannot now be edited or changed. 
    • Every subsequent execution of the script will contain the electronic approval signature in the run results. 
    • Full audit trail of approvals.

    Post Execution Approval

    • Electronically sign the test execution documentation.
    • Fully 21 CFR Part 11 compliant, with security encoded features to protect signing information. 
    • Workflow protected by User. 
    • Add multiple Electronic signature by defined roles to the validation outputs.


    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.

    Find out why Customers and Partners think so highly of ProcedureCapture®

    ProcedureCapture covers Requirements, Risk, Testing, Traceability and Defects with no add ons.

    All from one integrated, affordable and easy to use tool.

     

    CONTACTS
    Email: US@raltus.com
    Email: Europe@raltus.com
    Email: Ireland@raltus.com

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