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Quality Management System (QMS)

Module I of the GVP for the EU requires that all license holders (Marketing Authorisation Holders, MAHs) are expected to engage a Quality Management System (QMS) within the Company. Such a system is designed to ensure the Company has an active quality assurance programme in place with root cause analyses, corrective actions and also to monitor such outputs,  with the intention of seeing improvements within the Company in all aspects of Regulatory compliance whether the identified deficiency resides in Pharmacovigilance, Clinical or Regulatory.

The Company QMS system also forms part of the PSMF and should be part of the overall oversight of the Pharmacovigilance system by the EU QP PV.

Although PharSafer® is regularly inspected by potential and existing clients, as well as Regulatory Authorities, this does not guarantee quality progression but does provide a quality snapshot of what was occurring at that time.

As we cannot audit ourselves, PharSafer® consult an independent and experienced Pharmacovigilance expert to assess our processes, training, compliance approaches and outputs on an annual basis.  This approach to Quality Management aids with our compliance and excellence, helping us to ‘raise the bar’ in terms of our own expectations and client satisfaction.

From the results of such an audit, we as a Company will look to continually improve our processes, training and systems to ensure that we are constantly moving forward. Quality Management is a requirement under European law to demonstrate active Pharmacovigilance excellence.

Any findings from the PharSafer® audit are shared with clients, together with any root cause analyses, corrective action plans and resolutions, so that clients know any findings have been addressed and they can see that PharSafer® is adopting a transparent assessment of its capabilities and is committed to improving and providing the best service possible.

The Pharsafer Audit Team

Audits of the Company processes, Departments, Business partners and Suppliers is a required activity to ensure a Quality Standard. This is mandated in Module I of the EU regulations.

PharSafer® has an experienced audit team. They manage the internal audits of various Pharsafer® activities as part of our overall quality management system and can also help client companies in testing and strengthening their own levels of compliance following international regulations in preparation for regulatory inspections.

The PharSafer® audit team not only review the current practices in terms of regulatory compliance, but also identify potential business inefficiencies, personnel training issues, processes and can give advice in terms of best practice where regulation does not exist. The overall aim of having PharSafer® audit your company is to enable you to not only review your adherence to the regulations, but also to help drive the quality management approach of the company.

Our audit team has attended many regulatory inspections and safety audits. PharSafer® has taken part in regulatory inspections both for clients and regulatory inspections on PharSafer® itself by many external regulatory authorities. This has enabled us to remain up-to-date with the most frequent aspects concerning regulatory inspectors.

PharSafer® has been involved in Inspections from the FDA; HPB; Various Regulators in the EU since 2008 up to the present date.

Our team is there to help you prepare, conduct, assess and improve your compliance.

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