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