Corrective Actions
When there are adverse findings in regulatory authority inspections or resulting from independent audits of pharmacovigilance systems, companies can be faced with a daunting task for instituting appropriate remedies. PrimeVigilance and its consultants has been heavily involved in interpreting inspection and audit findings and can pitch the response at the appropriate level.
For example, it is essential that the findings are explored appropriately to determine whether they are manifestations of underlying problems or isolated events. The response to the findings is crucial in ensuring that suitable remedies - with achievable commitments - are offered. It is no exaggeration to say that getting this wrong can cost companies enormous sums in activities that may be either too superficial or too intensive and wide-ranging.
The implementation of a corrective and preventive action plan can be challenging in the extreme, and expert advice and support can make the difference between a vicious cycle of repeated inspections (or worse) and a rapidly achievable compliant system that is acceptable to auditors and inspectors.
PrimeVigilance - compliant and taking the right actions
- just one of the pharmacovigilance services from PrimeVigilance
For more information contact PrimeVigilance today