Audit Report and Compliance

Audit Report and Compliance

Audit Report Compliance is a critical function within a pharmaceutical and medical device company. It provides management with information about how effectively the company controls the quality of their processes and products.

Auditors must perform their job competently in the audit report compliance to ensure their company’s compliance with  USFDA GMP regulations and other quality standards like ISO, ICH. Audits also help to maintain these standards over time.

If a company isn’t checking up on its processes on a regular basis, small issues may snowball into critical issues over time. Products will suffer as processes slip away from compliance.

Audit Report Compliance Ultimate Solution To Handle Non-Conformities

The non-confirmities sited in the audit shall be handled in a very technical way, rather than just the reply.

The inadequate CAP (Corrective action plan) may have an impact on the final outcome of the audit.

The inadequate CAP may be the result of the inadequate RCA (Route cause analysis).

The conclusion of the closer of the audit points can be demonstrated with the correct CAPA and adequate review of the same at the defined intervals for a defined time.

CAPA(Corrective And Preventive Action) For Audit Report Compliance

The CAPA system is the cornerstone of a Quality Management System, especially in the Pharmaceutical/Medical Device Industry, and the backbone and driver for Quality improvements.

The CAPA system feeds the Quality System to improve processes, procedures, organization and business in a structured, well-documented and actionable way.

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 enables easy collection & analysis of information.

This information is used to identify & investigate existing; potential product & quality problems.

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There is a strong link between QUALITY and OPERATIONAL EXCELLENCE, as a well-established CAPA system will have its benefits for the business, for instance:

  • Improved safety and security
  • Improved customer satisfaction
  • Increased productivity
  • Infrastructure efficiency gains
  • Better product quality
  • Avoiding the cost of regulatory non-compliance

The risk-based CAPA requirements demand a well-documented system that determines the root cause of non-conformances, system failures or process problems, corrects the problems, and prevents them from recurring. The documentation must identify why something went wrong—or why it may go wrong—and what has been done to make sure it does not happen again.

In an industry where patients’ health and wellness depends on products functioning properly, an organization cannot afford any weak areas that could lead to nonconformities or lower quality products.

We help manufacturers to audit their current quality system reviews as per the standards to determine how effective it is in identifying quality problems.

We carry out a systematic and independent process audits to determine the conformity or nonconformity of your QMS requirements.

We also help you with an effective CAPA Management System which enables easy collection & analysis of information, this information can be used further to identify & investigate existing, potential product and quality problems.

We help the client establish a comprehensive CAPA procedure that is easily understood by all employees & which can be easily implemented.

Operon Strategist helps manufacturers with audit report compliance and also design a Post Marketing Surveillance 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.