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Quality

Audit Management Software System

MasterControl’s audit management software system automates tasks so that companies can successfully pass audits.

An integrated audit management software system helps you comply with the standards of a wide range of internal and external audits. These include the U.S. Food and Drug Administration (FDA), International Organization for Standardization (ISO), laboratory, clinical and quality audits. If you’re unprepared, audits can be painful and costly to your bottom line. An audit software system automates audit-related tasks and connects with a quality management system (QMS) to ensure documentation is accurate and complete. Audit software greatly reduces the time and effort needed to pass an audit.

Worried about passing an audit? Learn how to pass audits with flying colors.

01

Audit Preparation

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Planning for an audit can be half the battle of passing it. Audit management software with a drag-and-drop calendar function allows you to plan, schedule and create audit reports and perform a host of other functions. The advantage of integrated audit software is that it collects and shares documents and reports across the product life cycle.

02

Regulatory Compliance

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Quality and compliance audits are performed to ensure that your company is in conformance with regulatory standards. An example is ISO 9001 for quality systems. An audit management software system can quickly identify nonconformances, highlight areas of good practice and provide evidence of conformance in real-time audit checklists.

03

Corrective and Preventive Action (CAPA)

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When an audit finding occurs, an integrated audit management software system can automatically launch a response. The finding could be a necessary nonconformance, CAPA or supplier corrective action request (SCAR). Audit software will then generate a document request and activate changes to your workforce using the product's training task feature.

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Quality Assurance Audit

An automated QMS enables companies to eliminate the errors and delays that result from a paper-based system. A digital QMS also ensures that users’ quality processes are in compliance with international standards and regulatory requirements. Finally, companies that invest in a QMS will find greater operational efficiencies and increase speed to market.

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ISO Audit Compliance

For companies in regulated industries, the primary aim is to attain compliance with FDA, GxP and ISO regulations. An ISO audit helps ensure that your organization's internal processes align with relevant ISO standards. Automating your ISO audit processes and activities with ISO audit software can accelerate compliance efforts.

Don’t wait until you’ve been audited.

Companies can’t leave their audit preparation to chance. Discover the continuous value of being audit ready.

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