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.
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.
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.
We help the client establish a comprehensive CAPA procedure that is easily understood by all employees & which can be easily implemented.
Guidance for the closure of audit non-conformances:
Non-conformances observed during audits by regulatory bodies or by customers is a common occurrence. Operon Strategist helps the client in closing in this non-conformance by suggesting an appropriate course of action in order to remove the root cause of the non-conformance. We also help the client in root cause analysis to identify the root cause of a problem to prevent recurrence of the non-conformance.