Clinosol Research

DIFFERENCE BETWEEN MONITORING AND AUDITING

Introduction:

Monitoring:

Analyze the Flow of the business process, if it is controlled.
Quality Assurance.
Metrics /control measures (within bounds). Error rates, compliance rates, completion rates, accuracy rates, pass/fail thresholds, etc.
Triggers and escalation.
Spot checks.
A&M provides input in risk identification and verifies corrective actions.

Auditing:

Testing Output/Transactions/Items generated by a process.
Transactions-type Audits: Are claims, arrangements, enrollments, sales, etc correct/compliant?
Process/Systems: Do controls/procedures exist and work? – Verification Audits.

Auditing & Monitoring: Scope.

Auditing & Monitoring: Responsibilities.

Difference:

Monitoring	Auditing
It is a continuous process.	It is done either during trial or after the completion of trial.
It controls quality of trial.	It assures quality of trial.
It is done by monitoring who is a part of the trial.	It is done by an independent personal of trial.
Appointed by the sponsor	Appointed by Regulatory Authorities.
Part of the study conduct.	Independent third party.
Study conduct.	Study compliance.
Study duration	One time point.
Ongoing review of quality.	Snap shot of compliance.
Focused on data and daily activities of a site	Focus on processes and system.
Flag the issue and suggest remedial action.	Evaluate if remedial action is working.
Monitoring report + follow-up letter.	Audit report noting non-compliances.
Reply to follow-up letter.	Corrective and Preventive action plan(CAPA).

Auditing & Monitoring Program: Conclusion.

Auditing & Monitoring Program – Final Food for Thought

Rely on formal methods (Probability/Impact, Criticality Measure).
Define and Use metrics.
Include financial error rate into billing monitoring programs.
Set expectations what/how internal monitoring by operations is to report to Compliance.
Include formalized escalation procedures from routine to non routine auditing and monitoring.
Start small when using sampling and rely on threshold measures to decide on deeper dives.
Keep it simple.
Aggregate and trend, don’t lose sight of the big picture.
Incorporate sampling strategies that can easily be followed.
If extrapolation and disclosure is an issues, consider seeking outside help to raise the credibility of results. – Venture into data mining.

Reference:

Google.
Cornelia M. Dorfschmid, Ph.D. Strategic Management Services, LLC Washington, DC March 14, 2014

Student Name: Godawari Dnyaneshwar Balurkar

Student ID: 017/012023

Qualification: B-Pharm

e-Mail ID: gbalurkar23@gmail.com