Audit and Process Review


It is vital that your quality system complies with the legal requirements for pharmacovigilance tasks and responsibilities. This ensures the promotion of sale and effective use of medicinal products by providing timely information regarding their safety to patients, healthcare professionals and the public.

Why undertake audits?

In order to ensure that your company is providing the best possible services and managing risk successfully, regular audits are recommended. They ensure that all quality systems are of a high level and in accordance with EU legislation and UK medical regulation. For pharmacovigilance it is essential that your company has an adequately functioning pharmacovigilance system which ensures product benefit:risk is maintained and audits are essential for assessing this.

What will be covered in an Audit and Process Review?

Essjay Solutions will utilise their highly experienced professionals to identity the current processes in place at your site. This may include:

  • Ensuring the training in place is sufficient and records are being kept up to date to prove that you have appropriately qualified staff for the job
  • How effective the communication is between the Marketing Authorisation Holder and the NCA/EMA, to ensure all obligations are managed appropriately
  • Whether records are being stored correctly to allow for ease of retrieval and accurate reporting
  • Ensure continuous safety profile monitoring and benefit:risk evaluation, including risk management planning and signal detection
  • Business continuity plans are in place and established in a risk-based manner
  • Verifying computer systems and ensuring sufficient disaster recovery solutions are in place
  • Reviewing the QPPV interaction and communication within the Marketing Authorisation Holder and back-up procedures
  • Review of all safety related procedures and process including:
    • case processing
    • post authorisation studies
    • aggregate report preparation
    • signal detection
    • risk management
    • communication of emerging safety issue
    • urgent safety issue management
    • PSMF management
    • QPPV roles and responsibilities
    • risk minimisation
    • audits
    • safety variation management
    • receipt and flow of safety information
    • updating of product information
    • product quality interface

How can Essjay Solutions help?

We can undertake audits of specific facets of your PV system or provide an audit of the entire system to ensure all the interrelated processes are working adequately. Essjay Solutions are experienced at working with the systems you already have in place to tweak your processes to ensure compliance with regulations. We offer pragmatic solutions that ensure efficient effective correction of deficiencies found, usually without the need for major upheaval too. You can be confident by using our services that when the next inspection takes place, you will have everything in place to ensure a smooth process!