Audit Management Software Systems

Audit Management Software Systems for Life Science and Other Regulated Companies

An audit management software system greatly reduces the time and effort needed to pass an audit. The software automates audit-related tasks to simplify the process and can integrate with a document control system to ensure necessary documentation can be found and accessed. In many cases, reliable audit management software is the difference between passing and failing an audit.

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Übersicht über das MasterControl Qualitäts-Management-System (QMS)

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Hunderte von Unternehmen weltweit nutzen MasterControl zur Automatisierung zentraler Unternehmensprozesse und Dokumentenmanagement-Aufgaben, um die Zusammenarbeit zu fördern, die Entscheidungsfindung zu verbessern und die Markteinführung zu beschleunigen.

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Demo: MasterControl Audit Management Software

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FDA Audit Preparedness in Pharma Contract Manufacturing

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MasterControl Audit Quick Tour – Easing Audit Pains

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Produktdatenblatt: MasterControl Audit™
Weißes Papier: Qualitätsaudit – Ein Tool für kontinuierliche Verbesserung und Compliance Weißes Papier: The Top 5 Benefits of Electronic GLP Audit Management Weißes Papier: How to Successfully Complete an FDA Inspection
Toolkit: Audit Toolkit from MasterControl
E-Buch: Compliance and Technology: How to meet changing FDA expectations

MasterControl’s Solutions to Audit Management Challenges

Audit Management System Challenges	MasterControl Audit Solution
Disconnected Audit Management System Knowing what to audit and how often requires input from other quality systems, which is difficult to gather when dealing with a disconnected system.	Connected Audit Management Software MasterControl Audit integrates with other quality systems, such as supplier, risk and CAPA, which streamlines the process and ensures issues raised during audits are properly addressed.
Inefficient Audit Scheduling Planning and scheduling audits can be deceptively complex, especially managing the associated resources to make sure everything is done on time.	Advanced Audit Scheduling MasterControl automates audit scheduling and related activities, ensuring that nothing gets overlooked. The audit calendar provides a holistic overview of all audits and scheduling conflicts are highlighted for easy resolution.
Audit Management Results Lack Visibility Without a way to incorporate and analyze data from multiple audits, managers are unable to see the big picture of where a company stands.	Increases Visibility MasterControl Audit has powerful analytics and reporting capabilities that give a real-time view of the audit process and quality system. Managers can easily track issues raised during audits and ensure that they are resolved.

Audit Management System Challenges

MasterControl Audit Solution

Disconnected Audit Management System

Knowing what to audit and how often requires input from other quality systems, which is difficult to gather when dealing with a disconnected system.

Connected Audit Management Software

MasterControl Audit integrates with other quality systems, such as supplier, risk and CAPA, which streamlines the process and ensures issues raised during audits are properly addressed.

Inefficient Audit Scheduling

Planning and scheduling audits can be deceptively complex, especially managing the associated resources to make sure everything is done on time.

Advanced Audit Scheduling

MasterControl automates audit scheduling and related activities, ensuring that nothing gets overlooked. The audit calendar provides a holistic overview of all audits and scheduling conflicts are highlighted for easy resolution.

Audit Management Results Lack Visibility

Without a way to incorporate and analyze data from multiple audits, managers are unable to see the big picture of where a company stands.

Increases Visibility

MasterControl Audit has powerful analytics and reporting capabilities that give a real-time view of the audit process and quality system. Managers can easily track issues raised during audits and ensure that they are resolved.

Benefits of the MasterControl Audit Management System

Connected Audit Management and Quality ManagementIntegrates all steps in the audit process — from preparation to completion — and all aspects of quality management, such as CAPA and supplier management.
Simplified Approval and ReportsEliminates manual reports and uses automated ones, thereby expediting the process. Users can sign off electronically and missing signatures are easily identified.
Improved CollaborationAccessible from virtually anywhere because it is web based. Allows those who aren’t MasterControl users to still access the system via a guest connection.
Centralized Audit ManagementAllows advanced audit scheduling for multiple audit types and enables multiple auditors to collaborate from a single workspace.
Standardized Audit ProcessAllows multiple checklist templates to be created for different audit types, and templates can be used across the organization.
21 CFR Part 11 CompliantLimits access to authorized users and requires a dual-password approval process. Employs a secure, time-stamped audit trail that records the identity of those creating, modifying or deleting records.

QMS-Anbieter für die FDA

MasterControl Inc. und sein Partnerunternehmen i4DM erweitern ihr FDA-Projekt und wollen als QMS-Anbieter für einen zweiten FDA-Bereich fungieren. Die beiden Unternehmen sind seit 2009 als QMS-Anbieter für das Office of Regulatory Affairs der FDA tätig und möchten nun auch als Qualitätsanbieter für die Division of Pharmaceutical Analysis fungieren, die Teil des Center for Drug Evaluation and Research der FDA ist.

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