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A quality audit is to a regulated company what a medical examination is to a patient. It is a necessary and repeating procedure
for evaluating a quality systems general health and for diagnosing problems in order to correct them. In the FDA and ISO
environments, quality audits are required on an ongoing basis to help improve product quality and safety and to ensure compliance.
Heres how MasterControl addresses common challenges of both performance and compliance audits:
Challenges
MasterControl Solution
MasterControl Audit
Comfortably utilize familiar tools like Microsoft Word and Outlook to conduct audits
Effortlessly plan and schedule audit resources using MasterControls online drag and drop calendar
Easily create audit reports to rich text data that is maintained all the way from auditor entry and peer review through to
automated report generation
Enjoy seamless connections that enable stress-free management of CAPAs, suppliers, and risk
Easy to Use Offline Audit Tool: The system allows auditors to conduct their audits using a tool they are familiar with:
Microsoft Word. A Word plug-in allows auditors to capture their observations, rate their severity, categorize them, etc., all
within Word. Checklists can optionally be configured and embedded directly within the tool. When the auditor is back online,
he or she may simply connect and upload the audit directly from Word.
Automatic Audit Report Creation: MasterControl can automatically create rich text final audit reports, ensuring that auditors
do not have to reformat their findings when preparing their audit reports. This way professional final audit reports can be
created with the least amount of effort.
Audit Workspace: The system provides the audit team a workspace for each audit that allows them to manage all the
information about the audit, such as type of audit, dates, summary, scope, conclusion, audit team, observations, etc. It is
also the area for gathering such information as audit agendas, cover letters, and checklists.
Simplified Audit Planning and Scheduling: The system automatically generates an audit plan based on desired frequency
and risk. The plan can be updated through a drag and drop calendar interface. Scheduling conflicts are automatically
detected for easy resolution (i.e., double booked auditors, audits scheduled on a holiday, auditor is out of office, etc.). Audit
managers are able to efficiently and effectively control audit schedules, allocate resources, and manage risk. Auditors also
receive appointment emails that enable them to book their individual calendars.
Connected Solution: The Audit solution is tightly integrated with MasterControls Risk, Supplier and CAPA applications,
providing a comprehensive solution that facilitates efficient management of both internal and supply chain risk. The system
also integrates with other existing document repositories and enterprise applications like ERP, LIMS, etc., without expensive
custom coding.
Closed Loop Process: Actions can be launched directly from the audit workspace to ensure issues raised during the
audit are tracked to closure. Pertinent information from the audit observation is automatically entered into the appropriate
action form (CAPA, SCAR, Issue Review, etc), reducing data entry. It also shows the history of the entire process. Links are
maintained so users can review a completed process and trace the actions back through the chain of events.
Compliant System: MasterControl allows continuous compliance by ensuring your quality system is always ready for
inspections and audits. The system allows users to easily create and modify checklists, optionally score checklists, and
manage standards and criteria per standard clause.
MasterControl Audit
Analytics and Reporting Tool: MasterControls powerful reporting capabilities include dashboard, drill-down, and scheduling
features. The Analytics tool can be used to trend audit observations by category, checklist criteria, standard, supplier/site, or
rating, as well as trend audits by auditor, month, site, and so forth. The following is a subset of the customizable reports that
are also available:
Automated Tasks: All notification tasks pertaining to the audit process are automated. Automation helps simplify the
compliance environment, making it easier to stay compliant.
Part 11-Compliant Features: Provides time-stamped audit trail, reporting, and electronic signature capabilities that fully
satisfy FDAs 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password
expiration, encryption, and certification; and account lockout to stop unauthorized users from gaining system access.
Web-Based Platform: MasterControl is Web-based so it can connect all employees involved in the audit process from
virtually anywhere.
Unparalleled Validation: For FDA-regulated companies, MasterControl offers a validation approach that dramatically cuts
the time, pain, and cost involved in validation. MasterControls continuum of innovative products and services include the
revolutionary MasterControl Transfer OQ.
Expert Product Training: MasterControls Professional Services team, consisting of former auditors and system
administrators, has developed a comprehensive training program that serves as a foundation for successful project
implementation and helps companies realize software ROI faster.
Technical Support: Choosing MasterControl means getting the necessary technical support to ensure project success.
MasterControl offers the expertise, infrastructure, and flexibility to meet every customers needs, from initial installation to
regular maintenance.
About MasterControl
MasterControl Inc. produces software solutions that enable regulated companies to get their products to market faster, while reducing
overall costs and increasing internal efficiency. MasterControl securely manages a companys critical information throughout the
entire product lifecycle. Our software is known for being easy to implement, easy to validate and easy to use. MasterControl solutions
include quality management, document management/document control, product lifecycle management, audit management, training
management, bill of materials, supplier management, submissions management, and more. Supported by a comprehensive array of
services based on industry best practices, MasterControl provides our customers with a complete information management solution
across the entire enterprise. For more information about MasterControl,visit www.mastercontrol.com, or call: 1.800.825.9117 (U.S.);
+44 (0) 1256 325 949 (Europe); or +81 (03) 5422 6665 (Japan).
MasterControl Audit