監査管理


An effective electronic audit management software system can help a company efficiently manage the entire audit process from beginning to end.

The ability to conduct timely and effectual audits is vital to business success for companies doing business in regulatory environments. A comprehensive, cutting-edge audit management software system should be designed to be able to manage all aspects of the audit process—planning, scheduling, execution, report creation, peer review, response collection and closure—with speed and precision.


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Audit Management Software Solutions

The audit management software solution available from MasterControl enables companies to electronically manage their entire audit process. MasterControl Audit™ provides users with superior tools to conduct audit management as simply and rapidly as possible.

Some of the special features of the MasterControl audit management system include:

  • Automated Planning - The MasterControl audit management system enables automated planning of audits for any audit entity based on frequency and planned audit type. If the MasterControl Risk module is installed, this frequency and type can be driven by the risk score in conjunction with configurable risk mapping.
  • Electronic Scheduling - A planned audit changes to a scheduled audit when one or more auditors are assigned to it. When an auditor is assigned to an audit he or she will receive an Outlook appointment email for that audit to book their personal calendars.
  • Conflict Detection - A conflict can occur when an auditor is double-booked on more than one audit or is scheduled to be out of the office. The MasterControl audit management system highlights on the calendar any audits that have a scheduling conflict. A conflict is also highlighted if the audit is planned to take place on a holiday.
  • Filtering and Grouping - The audit calendar can be grouped to show audits by status, auditor, or audit type. The calendar can then be filtered to show only audits that match the selected items within the group. For example, the calendar can be filtered to just show audits that are scheduled or in-process.
  • Offline Checklists - The MasterControl audit management system uses a Microsoft Word document as the primary audit execution tool. Auditors complete checklist, make observations, and write reports all within Word and then click an upload button to submit the data to the application. The three sections of the audit management checklist include checklist criteria, header fields, and observations.
  • Audit Task / Workspace - The Audit Workspace is the collection point for all the information related to the audit. The data from each checklist is aggregated and displayed on the observation tab. The documentation tab is used to track audit agendas, cover letters, etc., and the information tab includes the header information about the audit. The workspace is also used by the audit management team to issue the audit report and manage the response collection process.
  • Compliance Management - Standards can be loaded into the system and specific criteria can be associated to specific sections of the standard. These criteria are compiled to create the audit checklists.
  • Report Templates - The MasterControl audit management system allows users to configure Microsoft Word "report templates" by placing field "bookmarks" into a standard Word document. These bookmarks are replaced with the data from the audit during the automatic report generation process. This enables users to format audit reports as they would like directly within Word.

Resources for Audit Management

品質監査ソフトウェアシステム や規制ガイドライン、マスターコントロールの比類のない品質監査ソフトウェアソリューションの詳細については、マスターコントロールのリソースセンターから入手出来る補完資料を参照してください。ホワイトペーパーやケーススタディ、Q&A、技術文書、製品データシート、オンラインデモなどの教育及び研究情報を、マスターコントロールの リソースセンター からダウンロードして、品質監査ソフトウェア要件の決定やこれらのニーズを満たす適切なシステムの導入に役立てることが出来ます。

About MasterControl and our Audit Management Software

MasterControl Inc. is a global provider of quality audit and document management software solutions for life science and manufacturing companies. The MasterControl suite is easy to use, easy to deploy, easy to validate, and easy to maintain. It incorporates industry best practices for automating and connecting every stage of the product development cycle, while facilitating regulatory compliance. By combining an integrated platform with a continuum of risk-based software validation products and services, MasterControl drives down the total cost of ownership and enables customers to extend their investment across the enterprise. Hundreds of companies worldwide use MasterControl for easier compliance, faster validation, and better process management. For more information, visit www.mastercontrol.com, or call 800-825-9117.

Contact Us About Audit Management Software

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