Our Projects
Investigators Certification
- Most frequently cited area during regulatory inspections
- No specific tool to evaluate the efficiency of investigations
- Inconclusive investigations thereby incorrect CAPAs
- Customised tool to determine the efficiency of investigations
- SMEs reviewed more than 20000 investigations (Production, QC, Engineering etc.)
- A proven program to demonstrate the efficiency during regulatory inspections
- Protocol and Checklist based review covering the investigation elements
- Coverage of all types of investigations
- Focuses on depth of investigation methodology and documentation
- Repeat Issues Addressal
- Mentorship to investigators to build capability
- Measurable and sustainable process
Baseline Assessment
Review of investigation procedures against the prevailing regulations and current industry trendsRetrospective review and scoring of investigations (e.g. manufacturing, quality control, engineering etc.) based on problem, root cause identified, CAPA and its documentation
Remediation & Mentorship
Implementation of Actions- Procedure Revisions
- Training – Case Studies based on the findings in Phase I baseline review and assessment
Onsite mentorship for Investigators on investigation process to enable them to identify root causes and Effective writing of Investigation
Investigators Evaluation & Qualification
Prospective Review and Evaluation of InvestigationsScoring of InvestigationsInvestigations Score Metrics EvaluationQualification of Investigators
INVESTIGATION ELEMENTS CONSIDERED FOR SCORING
Problem statement – Clear depiction of the problem (where, what, who and when etc.)Initial impact assessment: Affected Product / Materials; Impact to other sites and products / batches; and Escalation criteriaHistorical Review – Approach to identify Repeat CasesInvestigation and root cause analysisRC and CAPA synchronizationFinal impact assessment and batch disposition decision legitimacyCA and PA effectiveness check if neededA Protocol driven activity using a granular questionnaire-based checklistMetrics used to demonstrate the investigation robustness during investigationsInternalised by the companies for investigator qualification and investigations robustness evaluation.