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Quality Management Systems

Being ISO 9001:2015 certified company, implementation of the Quality Management System is mandatory for us. Continuous improvement is embedded in our “Quality Policy” and “Quality Objective” and we always ensure that the robust system is in place which enables us to serve our clients with the best possible quality of work.

The Quality System provides a high level of assurance of:

Qualification of Consultants/Auditors.

Consultants/Auditors and Personnel Training.

Non-Conformities Management.

Quality Rgreements and Quality Responsibilities.

Quality of the audit reports and Good Document Practices.

Incidents/complaints management and self-inspections.

Fulfilment of the audit life cycle (CAPA follow-up).

Documentation Management/Control.

CODE OF ETHICS for the Auditors and employees.

Our primary objective is to provide excellent services to customers by offering high-quality auditing/ consulting. Strategic decisions are always made with the aim of increasing customer satisfaction. We want to continuously improve the services we provide and prevent any negative customer experience. The consultant/ auditor qualification and Quality Agreement process represent a central building block of our quality promise.

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. It also reflects integrity and honesty of the work we provide to all our stakeholders which is must especially when it comes to conducting the Quality audits on behalf of the clients.

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 among our main missions.

All our Auditors/Consultants are also 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 actions on them; this had never happened though in our 15 years of tenure as we have maintained the strict compliance with our policies.

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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.