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 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 identifies suitable corrective /or preventive actions can take 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 easily convey 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. We help 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.