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Regulatory Compliance Services > Auditing Services

Auditing Services

With manpower shortages and the increased complexity of regulations and regulators expectations, companies are finding it more challenging to meet the requirements of their quality systems. ITS’ Regulatory Compliance Services team offers a range of services to help companies maintain compliance and improve their quality management system performance, by applying their extensive knowledge and experience, including:

Self-Inspection/Internal Audits

To comply with GMP and ISO, companies are required to perform planned independent internal, self-inspection audits and demonstrate audit records. These audits are performed periodically to assure that the quality system is robust and in compliance with established quality system requirements, in order to determine its effectiveness. ITS can help you to meet these requirements, by providing the resource to carry out the audits and produce the reports. The reports will outline the findings, including observations and non-conformities, and will help you to improve your quality management system adherence.

Root Cause and Corrective Action Service

Regulatory audits, internal and self-inspection audits occasionally produce non-conformities. Do you have the resource to investigate your non-conformities? ITS’ Regulatory Compliance Services team can assist by carrying out root cause investigations and determining effective correction and corrective actions, to ensure that your non-conformities are resolved.

Gap Analysis Audits

ITS also offers gap analysis audits to determine a company’s level of compliance to appropriate quality regulations, for example 13485, 9001, cGMP, JPAL. These audits can be performed prior to the implementation of a system and/or prior to a regulatory inspection or audit.

Supplier Audits

Most regulators expect companies to audit their suppliers, and in some cases their suppliers’ supplier. These activities can be a drain on resource. ITS can assist by performing supplier audits, producing audit reports and, where appropriate, carrying out follow up audits.

Contact our team today

For further information, please contact
our team on +44 (0)1642 222232 or