GMPPro Audit Management System
Capable to handle Supplier Audits, Customer Audits, Internal Audits / Walkthrough Audits and internal or intra unit Quality audits.
Good Control, Better Governance,
Over the past several decades, the pharmaceutical industry has grown exponentially, developing a complex system to ensure delivery of high-quality products to customers. Volumes of production have steadily increased with the years and so have the complexities and parameters of quality. Moreover, new product introductions are more complicated, featuring advanced drug-device combinations to diverse patterns of usage by patients. These factors alone add up to a fundamental challenge of the industry needing to improve control of its processes tremendously.
Quality pressures on pharmaceuticals stem from regulatory agencies but turning them to a control and audit-based approach helps maintain very high quality in terms of the product that reaches patients. Pharmaceutical companies are attuned to the challenges and work to ensure that quality issues are addressed and reported to comply with regulators’ standards. .
Focused on problem-solving, increasing process robustness and supporting production on-demand and in real-time is Motto Systems AMS. An intelligent audit system that effortlessly streamlines, centralizes and examines the production maze integrating different steps for a more efficient and effective process irrespective of increasing production volumes.
Highly secure and consistent, responsive and configurable the solution’s workflow engine automates all steps and manages the entire audit cycle helping to define, identify, prepare, schedule, execute, record, track, report and communicate multiple audit programs in one application. Designed in conjunction with several major pharmaceutical companies the solution is equipped with powerful tools and interfaces to simplify integrations, connect the audit process to CAPA, change control, track recommendations and action plans to improve quality & resolve issues.
- Streamline and centralize multiple processes
- End-to-end functionalities for managing the complete audit lifecycle
- Electronic archive and time-stamped audit trail for all audit plans
- Track data and processes in a single, comprehensive framework
- Strong role-based security, automated workflows for review & approvals
- Powerful Analytics and real-time visibility into the audit system
- Intuitive dashboards delivering real-time status, metrics, and trends
- Facility to track, report and store findings, audit activities, resolutions, and trends in a single repository
- Automatically initiate corrective actions, when required
- Integrates with other quality and compliance solutions such as CAPA, Complaints, and Document Management
- Systematically manages and records in data closed-loop routines to meet requirements for FDA and other regulations
Motto Systems Audit System is honed to build quality into the product and functional processes; organizing for quality in all functional areas and achieving compliance and sound governance; factoring quality into strategy and performance management, and fostering quality mind-set and behaviors improving business results and achieving business goals.