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MasterControl Audit

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.

How Can MasterControl Software Solutions Help You?


MasterControl Audit is an integrated part of the MasterControl quality suite. Organizationsespecially those with large, global
teamsutilize MasterControls Audit solution to manage their entire audit process from beginning to end.
MasterControl Audit enables effective and efficient:

Planning and scheduling of audits and resources


Execution of audits
Built in online and offline checklists with audit scoring
Capture of findings offline
Management of associated findings, responses, and corrective/preventive actions (CAPAs)
Reporting on the resulting data
Creation of customizable template-based rich text final audit reports

Heres how MasterControl addresses common challenges of both performance and compliance audits:

Challenges

MasterControl Solution

Disconnected Systems: Maintaining an effective compliance


management program requires connections between multiple
systems. For example, knowing what should be audited and how
often requires input from risk systems. Also, audit findings may
lead to CAPAs, and maintaining an approved vendor list requires
feedback from vendor audits.

Connected System: MasterControl connects the audit process


with the rest of the quality system for a comprehensive approach
to quality management. Audit data is integrated with supplier
scorecards, while risk scores can drive the frequency and type
of audits performed, and quality event forms (such as CAPAs or
SCARs) can be launched directly from audit findings. Connecting
these elements streamlines the process and ensures that issues
raised during audits are properly addressed.

Inefficient Scheduling: Planning and scheduling audits can be


deceptively complex. Some audits occur on a regular cycle, but
the types of audits (internal, customer, compliance) conducted
and their frequency can vary based on a number of factors.
Other audits come up on an ad-hoc basis and managing the
resources to make sure everything gets done can be a major
stumbling block, especially for companies with numerous audits.

Advance Scheduling: Automates planning of all recurring


audit related activities so they wont be overlooked. Scheduling
conflicts that result from double-booked auditors or out-of-office
events are highlighted for easy resolution. The audit calendar can
be searched and filtered to streamline the scheduling process.

Lacks Visibility: Its difficult to generate accurate and timely


reports and trends using disparate electronic spreadsheets and
paper documents. Without an effective reporting tool, managers
are unable to see the big picture of their audit program.

Increases Visibility: Provides powerful analytics and reporting


capabilities, including customizable reports and online charting.
Through the reports, managers get a real-time view of the audit
process and can be more proactive about improving the quality
system. Management can easily track issues that are raised
during audits and make sure that they are resolved.

Chasing Responses: Obtaining responses to observations can


be time consuming and inefficient. Auditors often have to spend
valuable and unnecessary time following up on responses to
their observations.

Flexible Response Capture: Responses can be captured


directly through the workspace, through the mobile interface,
or through a custom offline Word response input document.
MasterControl users participating in internal audits can submit
responses directly through the workspace while responses from
external responders can be captured via Guest Connect.

MasterControl Audit

What Sets MasterControl Audit Apart from Other Audit Solutions?


MasterControl provides professionals with superior tools to conduct and manage the perfect audit. With MasterControls unrivaled
Audit offering, auditors can:

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

Features and Benefits of MasterControl Audit:


Simplifies an Auditors Job
MasterControl Audit has been specifically designed to make life easier for auditors. The system enables auditors to use tools they are
already familiar with to get their work done.

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.

Delivers Powerful Tools to Compliance Managers


With MasterControl Audit, regulatory and compliance managers have a powerful set of tools to manage their team and audit
processes.

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.

Provides Audit Assurance to Executives


Regulatory personnel and quality executives can rest easy knowing that the MasterControl Audit solution is streamlining and
automating all compliance programs. They have real time access to important data always at their fingertips. Additionally,
MasterControls fully integrated quality suite assures that executives can maintain confidence when the organization is subject to
customer or regulatory audits.

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.

Alleviates IT and Project Management Concerns


The MasterControl Audit solution has been designed to be easy to validate, implement, and maintain which makes life a lot easier for
those tasked with rolling out an enterprise software system.

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).

2015 MasterControl Inc. All rights reserved.


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MasterControl Audit

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