Confidentiality

audit in pharmaceutical industry

Confidentiality

We believe in keeping the complete confidentiality for the information we receive from the clients as well as from the suppliers as a part of the project/ audit as the confidentiality constitutes one of the key agreements that should be established for the correct development of the activities carried out by PHARMALANE UK.

Preserving the confidentiality of the information provided to PHARMALANE UK’s associates and customers and other collaborating companies, and obeying the confidentiality agreements with the auditees is our among the main missions.

All our Auditors/Consultants are legally bound to strictly follow the Confidentiality as per AUDITOR’s CODE OF ETHICS as the confidentiality/technical agreement is signed with PHARMALANE UK and any breach to that could lead to legal action son them as well; this had never happened though in our 15 years of tenure as we have maintained the strict compliance with our policies.

The information considered as “Confidential” is; but not limited to:

  • Relation sponsor – audited company
  • Information provided by audit sponsors
  • Information collected during the audit related to the audited company and their processes
  • Audit reports

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    Audit Report Package

    Our Audit Report Package is very thorough and includes all of the following which is sufficient enough to qualify the supplier:

    • Full Audit Report.
    • Auditor’s CV.
    • Auditor’s non-conflict of interest declaration.
    • CAPA plan with evidence, as applicable.
    • Audit closure signed by Lead Auditor, with CAPA review confirmation.
    • Attachments including lists, certificates, licenses, layout etc.
    • Additional documents such as SMF, SOP index, Site presentation etc. as available.