What are technical details of xLM Managed Validation Service?

xLM Continuous Validation Managed Service features include:

  1. Validation Lifecycle Management

    1. “No Paper” Validation Infrastructure

    2. No Longer Limited to “Point in Time” Validation

    3. Manage Requirements, Specifications, Test Plans & Test Cases, Test Failures

    4. Manage Testing Schedules

    5. Manage Test Sequencing

  2. Test Automation

    1. Can achieve up to 100% Test Automation

    2. Model Based Test (MBT) Automation Framework

      1. Finite State Machine (EFSM) / State Diagram (UML) and Control Flow Graph (CFG) / Activity Diagram (UML).

      2. Model Graph, Sequence Graph, Coverage Graph and Message Sequence Chart (MSC).

      3. Multiple Types of Test Case Sequencers - Random Walk, Optimal Sequencer, Priority Path

      4. Test Data Generation: Pairwise, Combinatorial, Pattern Based

      5. Data Driven Testing (DDT)

      6. Load & Performance Testing

    3. Far Superior Coverage leveraging Mathematical Models

    4. Platform Support

      1. Multi-browser / Multi-OS Testing Built-in

      2. Full support for Web, Mobile, Java Apps & Windows Apps

      3. Full support for Web Services including REST

    5. Full Support for Performance / Load Testing

    6. Big Data Log Analysis for Compliance / Data Integrity Assurance

    7. Support for Cloud App Best Practice Analyzers to Enhance Security, Integrity and Compliance

  3. Validation Dashboard

    1. End to End Traceability in Real-time with Full Portal Access to End Customer

    2. Real-time Cloud App / Instance “Validation Health” Report

    3. Full support for on-demand validation summary report

    4. Real-time KPIs & Dashboards

    5. Real-time Requirements & Testing Heat Maps

    6. Real-time Coverage Graphs & Metrics

  4. Traceability

    1. Support for Item Level Bidirectional Traceability from Requirements, Specifications to Test Cases and Failures

    2. Assess impact of changes on various aspects (requirements, test plans, etc.)

    3. Perform Gap Analysis by looking at linked relationships that are n levels deep.

  5. Compliance

    1. 21 CFR Part 11 and Annex 11 Compliant

    2. Configured to meet GAMP 5