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The audits that matter How Internal Audit can help Some types of risks (e.g., procure-to-pay, vendor Operations management address these risks management) are common to every organization. But companies in the life sciences sector also face A strong internal audit function can help the organization thrive in very specific risks based on the industry’s unique Potential scope and objectives: this challenging risk landscape by integrating risk and compliance business and regulatory landscape. Here are some Assess the quality management system (QMS) in formulation audits designed to address sector risks that are • seamlessly into the rhythm of the business. development, manufacturing process and analytical process top of mind and could result in significant negative Evaluate the organization’s corrective and preventive actions By aligning its audit plans to key business issues and initiatives, IA • can leverage its deep assurance knowledge to provide the Board and impact for your organization. Evaluate key performance indicators (KPIs) that should be • management visibility into these risks and other pressing concerns. identified and used to monitor effectiveness of processes. These Internal Audit is uniquely placed to offer these insights because indicators can be derived during the development process of its enterprise-wide view, which allows IA to connect the dots and also from manufacturing experience. They can be used as across the entire organization. Leading organizations are taking enablers for continual improvement Research, discovery and Review the use of quality risk management that can facilitate advantage of IA’s strengths by treating the function as a trusted • strategic advisor. Keeping its feet firmly planted in the assurance clinical trials regulatory compliance to a substantial degree and also improve functions that represent its core competency, IA is adding value to quality of communication between industry and regulators Measure process capability life sciences organizations by focusing on the risks that matter. • Potential scope and objectives: Review procedures for continuous quality verification The audits that address these risks require a solid understanding • Evaluate compliance across the clinical trial ecosystem • Evaluate packaging and labeling compliance of the organization’s internal audit standards and approach; • Measure the overall cost of research and development and an understanding of the organization’s strategic objectives and • Key questions to consider business activities; robust, up-to-date technical IT knowledge; clinical trials Are the raw materials tested appropriately? Capture specification (OOS) events from laboratory testing in • strong analytical skills; and the ability to communicate clearly and • good laboratory practices (GLP) environments Are the suppliers evaluated and qualified? concisely. The appropriate mix of resources will vary based on the • organization and its IA bench strength. Are processes aligned with 21 CFR? Key questions to consider • Are past due corrective and preventive actions (CAPA) and Is good clinical practice (GCP) maintained? • • deviations properly identified and monitored? Are patient recruitment targets achieved? • Do the facility and its many departments (organizational units) Are good documentation practices followed for patient records? • • operate in a state of control as defined by the good manufacturing Is safety reporting (adverse events) done appropriately? practice (GMP) regulations? • Does the quality assurance (QA) department or unit routinely Have the contract research organizations (CROs) been paid as per • • the services rendered? review production records to make sure that procedures were Are there any protocol violations? If yes, what are the remedial followed and properly documented? • Are all written QA procedures current and approved? measures taken? • 66 | | HoHow Inw Intternal Audit cernal Audit can help lifan help life se sciencciencees cs compompanieanies change with the times change with the timess How Internal Audit can help life sciences companies change with the times | 7

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