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Supplier Auditing & CAPA Management

To support our clients by timely providing supplier qualification and management services in GMP compliant and cost effective manner

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Scheduling

-Tracking of auditing schedule for your suppliers / CMOs / service providers. -Defining agenda for each audit, in consultation with client QA team. -Sharing the agenda with supplier to be audited.

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Audit Management

-Execution of audit by Tejisha’s auditor as per the defined Agenda -Collection of the documents that supports the non-conformances identified during the audit. -Discussion of NCs with supplier QA team in audit closing meeting

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Report Writing

-Writing an audit report with observations and findings and sharing with client, within twenty (20) calendar days from the final day of the audit. -Revising the report, if needed, based on the review by client and sharing

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CAPA Management

-Follow-up with supplier for the CAPA report with target time lines for the NCs reported in the audit report. -Review of CAPA report and sharing the corrections / comments with supplier, if any. -Receipt of the final response report from the supplier, review for adequacy and sharing with client along with supporting

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Follow-up Auditing

-These audits will start when client makes a request. -When a supplier audit results are undesirable, follow-up audits may be requested. -A follow-up audit will involve planning the audit, working with the supplier, reviewing the results and report from the initial audit, traveling locally, and producing a report.

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Desk-top auditing / paper Based auditing

Desktop / paper based audits are conducted if client makes a request for such audit Evaluation questionnaire provided by client shall be shared with supplier for execution Review of filled questionnaire for its adequacy along with applicable attachments

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