Operon Strategist audits the existing CAPA system of clients determines how effective it is in identifying correcting quality problems. An effective corrective & preventive action system enables easy collection & analysis of information. This information is used to identify & investigate existing; potential product & quality problems.
Operon Strategist helps manufacturers design a PMS plan specific to a product or family of products.
We also guide manufacturers in establishing an effective adverse event reporting system so that information regarding an adverse event/reportable event can be easily conveyed to regulatory bodies as well as the public.
After identifying a recurring quality problem, root cause analysis is done to identify the root cause of the recurrence. Once the root cause has been identified as suitable corrective &/or preventive actions can be taken to avoid future recurrences