INTERNAL AUDIT independent assurance and consulting activity designed to improve organisation's operations Every month QA team will

month QA team will do internal audit

AUDIT EXTERNAL AUDIT Company conducts on its vendors and sub-contractors Vendor Qualification, monograph and Vendor audit

REGULATORY AUDIT The audit of a quality management system demonstrate conformity with
Audits carried out by Regulatory bodies
quality management system requirements for regulatory purposes

AUDIT: A systematic and independent examination to determine whether quality activities and related results
Objective of Audits comply with planned arrangements and are implemeted effectively and are suitable to achieve objectives.

Verify the authenticity and accuracy

AUDIT FINDINGS: Results after evaluation of collected audit evidence against audit criteria.
Audit findings can either conformity or nonconformity with audit criteria or opportunities for improvement.
Detection and prevention of errors

Smooth functioninf of internal check system AUDITEE: Any organization whose quality systems is to be audited for compliance with relevant medical device
regulatory requirements. The organization may be the manufacturer and/or their suppliers.

Review of organisational policies and operations

An auditor apponted to manage an audit

Observe Trends document, Batch Manufacturing Record (BMR)
Change control files and Corrective Action and Preventive Action CAPA documents
Lead Auditor
A site having an identified central function, by which the quality management
Lead Site system applied to the sites is established and subject to continuous
surveillance and internal audits.
A lead site can require any site to implement corrective actions when needed.

NON-CONFORMITY: Non-fulfillment of a requirement Site Master File Detailed information of manufacturing site.
Orginal document which the auditor use for inspection of the company

OBJECTIVE EVIDENCE: Verifiable information or records pertaining to the quality of an item and implementation of QMS requirement

Regulatory Audit Report: It is a set of documents from the regulatory audit team containing adminstrartive data, summary of locations, functions or processes that were
audited