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.
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