Auditing Service

Service Details:

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.

Service Details:

GMP Audit Service is the Quality Assurance that ensures products are consistently produced and controlled to the quality standards appropriate for their intended use and conform to the regulatory requirements stipulated by health authorities.

Service Details:

Service Provider of social accountability as 8000, Third Party Auditing Service. Health and safety management system, quality management system environmental management system, quality management system, iso 9001:2008, food safety management system iso 22000, HACCP, halal food certification, CMMI certificate, CE marking, security management systems, iso-ts 16949:2002, social accountability as 8000, good manufacturing practices, second party audit services, third-party audit services.