GxP Technologies

Automated Application Lifecycle Management (ALM)

FAQ: CSV, CSA, and Why the Paradigm Shift

Adopt an integrated approach that simplifies GxP systems management—including on-premises systems—and delivers a single source of truth for GxP system inventory.

Imagine an end-to-end platform for GxP systems lifecycle management where the change process is connected to validation to ensure every step is completed throughout the process. And to accelerate release cycles, automated testing is used for GxP Software-as-a-Service (SaaS) releases.

ProcessX + Cloud Assurance as a Platform

ProcessX lifecycle management handles all lifecycle activities for GxP systems, including:

  • Automated Testing
  • Change Management
  • Incident Management
  • User Access
  • Periodic Review
  • and more

As part of application lifecycle management (ALM) in ProcessX, validation lifecycle management (VLM) generates all your validation artifacts automatically and compliantly using the Computer Software Assurance (CSA) methodology or Computer System Validation (CSV) methodology. You’ll receive:

  • Validation plan
  • Requirements management
  • Risk management and assessment
  • Traceability in real-time
  • Validation Summary report
  • Test and protocol development that leverages automated testing

Cloud Assurance as a Platform (CAaaP) uses automation to handle all regression testing for your GxP systems and keep you in a continuously validated state.

Together, CAaaP and ProcessX deliver a holistic approach to manage the quality of all your GxP SaaS or on-premises systems and achieve unparalleled efficiency and compliance.

Key benefits include:

  • Single Source of Truth: Creates a centralized GxP system inventory to improve visibility and control over the quality management process.
  • Time and Cost Savings: Improves operational efficiency with ~60% reduction in time and ~50% reduction in cost required to manage GxP systems.
  • Flexibility: Gives you the option to include analytical and manufacturing systems for total GxP system management.

Key features include:

  • Validation Lifecycle Automation: Leverages pre-built and configurable workflows to ensure your standard operating procedures (SOPs) are always followed.
  • Automated Testing: Simplifies validation and release management activities and eliminates deviations.
  • Change Management: Streamlines changes in GxP systems and ensures they are done in a controlled and compliant manner.
  • Incident Management: Provides a systematic approach to manage and resolve incidents while minimizing the impact on quality and compliance.
  • User Access Management: Enhances security and auditability by controlling access to GxP systems and ensuring regulatory compliance.
  • Periodic Review: Facilitates regular reviews of GxP systems to ensure they are continuously compliant with quality standards.
  • Regulatory Applicability Assessment: Determines what and how regulatory requirements impact a system or software.

The CAaaP+ProcessX approach to GxP systems management is efficient, compliant, and cost effective. It meets your organization’s needs to streamline operations, reduce costs, and maintain regulatory compliance, all while delivering high-quality output.

Integrated GxP Compliance for the Life Sciences Industry

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