Quality System Audit Services

 

Quality Auditing Services for the Food & Pharmaceutical Industry serves the needs of companies operating in FDA-regulated industries such as medical devices, pharmaceuticals, organizations, and food. We specialize in quality compliance, quality assurance, quality system testing, and quality control.

 

Quality Systems Compliance Inc. provides audit services including gap assessments, internal audits, supplier audits, and due diligence audits.

Gap assessment is a proactive approach that allows you to accurately understand the control of your current quality management system. This type of quality system audit helps develop a plan of action before a visit by a recognized body or competent authority.

Internal auditing is a requirement of most ISO and regulatory quality systems. Internal audits are conducted at least once a year to identify potential internal compliance gaps. Internal audits can also be used to assess the effectiveness of process interactions.

Supplier audits are a requirement of most ISO-based and regulatory quality systems. Effective supply chain management is essential to ensure compliance in global markets. Assessing and monitoring supplier capabilities and performance can help avoid surprises and regulatory compliance issues.

Due diligence testing is essential when considering a merger or acquisition. Before signing a contract, ensure that your quality system and related records meet quality and regulatory requirements.

 

Audits

Audit support includes GAP assessments, internal audits, supplier audits, ASQ audits, due diligence, mock FDA audits, and MDSAP audits.

Gap assessment is a proactive approach that can provide an accurate picture for managing your current quality management system. This type of audit helps to develop a plan of action before a visit by a notified body or competent authority.

Internal auditing is a requirement of most ISO and regulatory quality systems. Internal audits are conducted at least once a year to identify potential internal compliance gaps. Internal audits can also be used to assess the effectiveness of process interactions.

Supplier audits are a requirement of most ISO-based and regulatory quality systems. Effective supply chain management is essential to ensure compliance in global markets. Assessing and monitoring supplier capabilities and performance can help avoid surprises and regulatory compliance issues.

Due diligence testing is essential when considering a merger or acquisition. Before signing a contract, ensure that your quality system and related records meet quality and regulatory requirements.