Audit is a fact finding process which helps any organization to get aligned to the journey towards continual improvement. It is mandated for the Life Sciences Industry that the Internal Audit should be performed at a periodic intervals to ensure that the organization is functioning in alignment with the Policies, Procedures and applicable regulatory requirements. The Audit findings should be remediated through appropriate CAPA as a part of the continual improvement which would be again audited to ensure that the CAPA implementation is effective. From the regulatory agencies standpoint, it is the responsibility of the regulatory authorities to ensure Product Quality and Patient Safety. It is being effectively achieved through Inspections followed by Non conformance reports, Warning Letters and so on. Internal audits make the individual organization to get prepared for the regulatory audits by identifying their weak areas and remediating the same through appropriate actions.
Suppliers/Vendors Qualification is an another important area for the Life Sciences Industry where the Suppliers/Vendors need to meet the required approved specifications for the materials, equipments or services they provide to the Industry. The individual firms are responsible for ensuring that the high quality products are being delivered, meeting all requirements and specifications. As many of the activities are outsourced to Suppliers/Vendors, they play a key role in accomplishing these mandates. So the process for Selection, Audit, approval and qualification of Suppliers/Vendors needs to be documented with appropriate Risk assessment based on the nature of the product or services.
SANHAR has experienced quality auditors who would be able to help our customers to perform any kind of audits to comply with the appropriate regulatory requirements. We offer the following services related to Auditing.