GAMP-Compliant AI Platform for Life Sciences & Regulated Industries
Good Automated Manufacturing Practice (GAMP) provides a structured framework for validating automated systems used in regulated industries.
AmpleLogic solutions are designed in alignment with GAMP principles to simplify validation and reduce compliance risk.
Annual Product Quality Reviews involve large volumes of structured and unstructured data from multiple systems and departments.
Maintain complete traceability of system activities, configuration updates, and data changes. Every action is recorded with time stamps and user details to ensure transparency and inspection readiness.
Define structured access permissions based on user roles and responsibilities. Ensure segregation of duties while protecting sensitive data and critical system functions.
Track and document all modifications automatically, preserving a complete history of system and configuration changes for audit and review purposes.
Enable secure, authenticated electronic approvals with documented identity verification and date-time stamping. Support regulatory compliance requirements for validated computerized systems.
Protect data accuracy, consistency, and reliability through built-in validation rules, secure storage, and controlled system access aligned with regulatory expectations.
Manage system configurations within a structured framework that ensures changes are evaluated, approved, and documented in accordance with compliance standards.
At AmpleLogic, we follow a structured, risk-based approach aligned with GAMP 5 guidelines to ensure systems are fit for intended use, validated appropriately, and fully traceable throughout their lifecycle.
Our methodology focuses on clear system categorization, controlled configuration, documented validation processes, and ongoing compliance monitoring—helping organizations reduce validation effort while maintaining regulatory confidence.
Discover how AmpleLogic’s aPaaS enables life sciences organizations to configure, deploy, and scale compliant applications with clarity and control. See how our platform supports real-world regulated processes from quality and laboratory operations to manufacturing and regulatory management.
AmpleLogic GMP Solutions are designed to help regulated organizations simplify compliance while maintaining operational efficiency. Our platforms embed GMP-aligned controls directly into system architecture ensuring structured workflows, validated configurations, and complete traceability across processes.
Purpose-designed to support GMP compliance with structured workflows, traceability, and validation-ready architecture.
Aligned with GAMP principles to reduce validation effort while maintaining regulatory confidence.
Audit trails, electronic signatures, and role-based access embedded directly into the platform.
Flexible solutions that grow across products, sites, and evolving regulatory requirements.
FAQ’s
GAMP stands for Good Automated Manufacturing Practice. It’s a set of guidelines and best practices for the pharmaceutical industry to ensure that automated systems are properly designed, validated, and maintained.
AmpleLogic GAMP Solutions provide compliant digital solutions that help organizations meet regulatory requirements through validated systems and documentation.
Compliance is ensured through validation frameworks, audit trails, documentation, and adherence to global regulatory guidelines.
aPaaS (Application Platform as a Service) enables rapid application development, deployment, and management in a compliant environment.
Key features include compliance-ready workflows, audit trails, validation support, scalability, and enterprise security.
Data integrity is ensured through access controls, encryption, audit logs, and compliance with ALCOA+ principles.
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