CAPA Management

  • 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.

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

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

Enquiry
 line1