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. Case 483/Warning Letter/Import Alert/No Objection Certificate/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
Benefits of Regulatory Surveillance Software
- Regulatory observations in a single application are readily available
- Numerical sequences that are produced automatically
- Relationship between the Global Action Plan and the Site-Specific Action Plan
- Electronic signatures help with data integrity
- Processes that are well defined and follow Standard Operating Procedures (SOPs)
- Intuitive workflows manage tasks and notifications using this regulatory compliance tracking software
- Trends that have been seen area-wise and in terms of the regulator
- Workflow configuration would remove manual procedures and reduce compliance management complexities to a minimum
- AmpleLogic’s Regulatory Tracking Software complies with relevant requirements such as 21 CFR Part 11, MHRA, and EU Annex 11
AmpleLogic Regulatory Surveillance & Tracking Software is a versatile web-based solution that can be readily customized to meet any organizational requirement, allowing you to constantly assess and record compliance.
Please contact the AmpleLogic Team if you would like to explore how the AmpleLogic Regulatory Surveillance and Tracking Software or Regulatory Surveillance Trackers will benefit your business.