Guidance For Audit Report And Compliance

  • Audit Report And Compliance
    Audit Report And Compliance
    Operon Strategist helps manufacturers design a PMS plan specific to a product or family of products.
  • Handling Customer Compliants
    Handling Customer Compliants
    Medical device manufacturers’ ultimate user is the customer whose satisfaction in using a particular product is of utmost importance.
  • Audit Report And Compliance
    Audit Report And Compliance
    We 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.

Related Projects:

Handling Customer Complanits

Name: Handling Customer Complaint
Year: 2001
Type: Got it

Audit Report NAd Compliance

Name: Audit Report & Compliance
Year: 2003
Type: Got it

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