Quality assurance and data integrity from an auditors’ viewpoint
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The regulatory bodies for the pharmaceutical industry mandate that organisations be audited by an independent external auditor that is up to date on the latest regulatory requirements, to ensure companies are working in accordance with regulations for compliance and data integrity set forth in their respective countries.
The regulatory environment also requires computerised systems, including analytical instruments and data handling systems to be appropriately validated and have suitable controls in place to ensure the quality and integrity of the data that they generate – and ultimately safeguard the safety of the patient. Organisations must be mindful of the rules, regulations and guidance when implementing new systems and upgrading existing systems, to ensure they remain compliant.