Regulatory Surveillance Tracker

Regulatory Surveillance and Tracking Software

Pharmaceutical companies are subjected to many inspections by government agencies such as the FDA and MHRA. As part of the audits, observations are made in the following areas: production, packing and branding material; laboratory controls, quality, and the facility. Regulatory Guidance/483/Warning Letter/Import Alert/Notice of Concern/GMP Trend are examples of typical observations.

If a company has 10 plants, it’s easy to find observations made in one of the plants and apply them across the board.

AmpleLogic’s Regulatory Compliance Tracking Software helps to:

• Observations of all plants will be tracked and made available to all the plants by AmpleLogic Regulatory Tracking Software
• Evaluate process by the regulatory heads, head of quality assurance, site Quality Assurance, and site head
• Risk assessment – action plan, the responsible personnel, and the timeline for completing the project
• This Regulatory Surveillance Software will capture US FDA/MHRA Observations made by the Regulatory Surveillance SPOC and the Corporate SPOC
• Examining the efficacy of the CAPA
• Enhance impact evaluation
• Implement the Global Action Plan will across all plants
• Conclusion of the observation
• Capture and keep regulatory developments for conformance and knowledge sharing
• In addition to full reporting features, the AmpleLogic regulatory compliance tracking system may automatically produce reports as needed