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 Tracker helps to:
- List and track the Observations of all plants and is accessible to all the Plants
- Record the US FDA /MHRA Observations by the Regulatory Surveillance SPOC and Corporate SPOC
- Review Process by the Regulatory Heads, Head Quality Assurance, Site Quality Assurance and Site Head
- Risk Evaluation – Action plan, Responsible Person and Target Date
- 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
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
- Observations trends Area-wise, Regulator wise
- Compliant with 21 CFR Part 11 and EU Annex 11
If you would like to discuss how the AmpleLogic Regulatory Surveillance and Tracking Software can help in your business, kindly contact AmpleLogic Team.