Regulatory Surveillance and Tracking Software
Pharmaceutical Companies go through multiple audits by Regulatory bodies like the US FDA/ MHRA. During the Audits, observations are raised in the Production System, Packing and Labelling System, Material System, Laboratory Control system, Quality System, and Facility & Equipment System. The typical Observations include Case 483/Warning Letter/Import Alert/No Objection Certificate/Notice of Concern/GMP Trend.
For example – An organization with 10 plants raised observation in one of the plants that can certainly be replicated in other plants to improvise the entire process.
AmpleLogic’s Regulatory Compliance Tracking Software helps to:
- AmpleLogic Regulatory Tracking Software will list and track the observations of all plants and is accessible to all the plants
- Review Process by the Regulatory Heads, Head Quality Assurance, Site Quality Assurance and Site Head
- Risk Evaluation – Action plan, Responsible Person and Target Date
- This Regulatory Surveillance Software will record the US FDA /MHRA Observations by the Regulatory Surveillance SPOC and Corporate SPOC
- CAPA Effectiveness Review
- Consolidate Impact Assessment
- Global Action Plan to rollout in all the plants
- Observation Closure
- Record and maintain regulatory updates for compliance purposes and knowledge sharing
- AmpleLogic regulatory compliance tracking solution has comprehensive reporting capabilities and auto generate reports as required.
Regulatory Surveillance Software Benefits
- Availability of Regulatory observations in a single application
- Auto generated sequential numbers
- Link between Global Action Plan and Site-Specific Action Plan
- Data Integrity issues addressed via Electronic Signatures
- Defined Processes adhering to the SOP’s
- This regulatory compliance tracking software automate tasks or activities and notifications through intuitive workflows.
- Observations trends Area-wise, Regulator wise
- Configure business workflows that eliminate manual paper processes and minimizes the burden of compliance management.
- AmpleLogic Regulatory Tracking Software is compliant with 21 CFR Part 11, MHRA, EU Annex 11 and other applicable standards.
AmpleLogic Regulatory Surveillance and Tracking Software offers a flexible web based solution that can be easily tailored to fit any business need to help you consistently measure and document compliance.
If you would like to discuss how the AmpleLogic Regulatory Surveillance and Tracking Software or Regulatory Surveillance Trackers can help in your business, kindly contact AmpleLogic Team.