Quality Management & Auditing

or call +44 1624 672777

Quality Management System Creation & Review

The Quality Management System (QMS) underpins the Pharmacovigilance System and, as such, a good QMS is critical in order to ensure that compliance is maintained. Panacea can help by providing a review of your existing QMS, or support you with implementing a brand new one. Our in-house Quality team have experience working with QMS systems within ‘Top 5’ pharma companies.

 

Third Party, Vendor & Risk Management

Third party, Vendor and Risk Management is a continually changing environment for all companies and Panacea is available to support you in mitigating any potential risks by taking care of ongoing compliance.  We have a number of practical solutions to support you with this, and can provide as little or as much support as you need. Our services include writing of due diligence risk questionnaires, conducting independent due diligence audits and assessing third party risk so that companies can strategically plan for upcoming audits.

 

Pharmacovigilance Agreements (PVAs) / Safety Data Exchange Agreements (SDEAs) – Maintenance and Management

Panacea currently manages and maintains many PVAs and SDEAs across a number of clients. We work with our own in-house management tools and procedures in synchrony with other companies’ tools, systems and in-house procedures. We pride ourselves on our flexible approach and the support we offer when managing agreements reflects this.

 

GPvP Auditing & Inspection Readiness

Panacea’s Quality function has first-hand experience of Regulatory Authority inspections. We use this experience to offer inspection readiness training, as well as post-inspection assistance and support.

 

We can perform independent pharmacovigilance audits (remote or on-site) for any scenario, including: due diligence, third party PVA/SDEA compliance audits, and full pharmacovigilance service audits – whether routine or ‘for-cause’.

 

Internal reviews/audits are also a great way to understand your company’s compliance and Panacea can support you with this. A great example of this is the review of a specific area such as business continuity in order to mitigate any perceived risk.

 

CAPA Management & Assistance

Panacea’s experienced team are able to support you with the creation, implementation and closure of Corrective & Preventative Actions (CAPAs). We have experience in both the creation and management of CAPA response documents. Whether CAPAs stem from a routine audit or from a Regulatory Authority inspection, our team will work to ensure that you maintain your positive reputation.

 

We can manage your CAPAs as part of the outsourcing of a PV service or of an SDEA management service and Panacea is compliant in CAPA management, TREND identification/management and Impact analysis review.

 

SOP Review, Design, Writing & Implementation

Quality and efficiency is our mantra at Panacea and we enjoy helping clients to design, draft and implement practical Standard Operating Procedures (SOPs), Local Working Practices (LWPs) and Flow Charts.

 

We have supported companies by performing GAP analysis reviews of procedures in order to ensure compliance.

 

We are also able to provide a review of your SOPs and suggest procedural updates and process improvements, and will cross-check against your PSMF Annex E to identify any potential GAPs.  We can do this as part of an internal review and prepare project plans for improvements on your behalf.

 

Pharmacovigilance Training

Whether you require annual or ad hoc training, Panacea can provide a tailored solution to meet your needs. Our training can cover general pharmacovigilance, or more focussed training on an individual area – we ensure that you get the knowledge and outcome that you seek.

 

Key Performance Indicators

Panacea’s experts are well versed in helping clients to develop and monitor essential pharmacovigilance KPIs. We can help you to ensure that you implement the necessary performance measures, and can provide assistance in identifying areas of under-performance and the reasons for this.

 

Quality Review of Pharmacovigilance Documentation

Panacea often receives requests from clients relating to the review of pharmacovigilance documentation and reports, prior to sending externally. Our experienced experts can identify any potential gaps and advise on the best way to close them.

 

or call +44 1624 672777