Automated Application Lifecycle Management (ALM)

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.