- Audit Report And ComplianceOperon Strategist helps manufacturers design a PMS plan specific to a product or family of products.
- Handling Customer CompliantsMedical device manufacturers’ ultimate user is the customer whose satisfaction in using a particular product is of utmost importance.
- Audit Report And ComplianceWe Provide Medical Device Post Market Support For CAPA compliance , Audit Report & Compliance , Labeling Compliance.
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 enable easy collection & analysis of information. This information is used 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 suitable corrective &/or preventive actions can be taken to avoid future recurrences