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 system’s 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. Organizations—especially those with large, global
teams—utilize MasterControl’s Audit solution to manage their entire audit process from beginning to end.
MasterControl Audit enables effective and efficient:
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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

Here’s 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 won’t 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: It’s 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™

. Additionally. When the auditor is back online. Auditors also receive appointment emails that enable them to book their individual calendars. ■■ Compliant System: MasterControl allows continuous compliance by ensuring your quality system is always ready for inspections and audits. without expensive custom coding. he or she may simply connect and upload the audit directly from Word. auditors can: ■■ ■■ ■■ ■■ Comfortably utilize familiar tools like Microsoft Word® and Outlook® to conduct audits Effortlessly plan and schedule audit resources using MasterControl’s 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. auditor is out of office. all within Word. ■■ Connected Solution: The Audit solution is tightly integrated with MasterControl’s Risk.e. The system enables auditors to use tools they are already familiar with to get their work done. MasterControl Audit™ . MasterControl’s fully integrated quality suite assures that executives can maintain confidence when the organization is subject to customer or regulatory audits. etc). conclusion. ■■ Automatic Audit Report Creation: MasterControl can automatically create rich text final audit reports. suppliers. The system also integrates with other existing document repositories and enterprise applications like ERP. ■■ Closed Loop Process: Actions can be launched directly from the audit workspace to ensure issues raised during the audit are tracked to closure. etc. They have real time access to important data always at their fingertips. LIMS. double booked auditors. Issue Review. summary. SCAR. such as type of audit. regulatory and compliance managers have a powerful set of tools to manage their team and audit processes. dates. It also shows the history of the entire process. and risk Features and Benefits of MasterControl Audit: Simplifies an Auditor’s Job MasterControl Audit has been specifically designed to make life easier for auditors. This way professional final audit reports can be created with the least amount of effort. A Word plug-in allows auditors to capture their observations. audit team. Supplier and CAPA applications. and checklists. observations. optionally score checklists. ■■ Audit Workspace: The system provides the audit team a workspace for each audit that allows them to manage all the information about the audit. providing a comprehensive solution that facilitates efficient management of both internal and supply chain risk. ■■ Simplified Audit Planning and Scheduling: The system automatically generates an audit plan based on desired frequency and risk. ensuring that auditors do not have to reformat their findings when preparing their audit reports.). rate their severity. It is also the area for gathering such information as audit agendas. and manage standards and criteria per standard clause. Links are maintained so users can review a completed process and trace the actions back through the chain of events. scope. categorize them. The plan can be updated through a drag and drop calendar interface.. reducing data entry.What Sets MasterControl Audit Apart from Other Audit Solutions? MasterControl provides professionals with superior tools to conduct and manage the perfect audit. 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. ■■ Easy to Use Offline Audit Tool: The system allows auditors to conduct their audits using a tool they are familiar with: Microsoft Word®. Pertinent information from the audit observation is automatically entered into the appropriate action form (CAPA.. etc. Delivers Powerful Tools to Compliance Managers With MasterControl Audit. etc. audits scheduled on a holiday. and manage risk. Checklists can optionally be configured and embedded directly within the tool. With MasterControl’s unrivaled Audit offering. cover letters. allocate resources. The system allows users to easily create and modify checklists. Scheduling conflicts are automatically detected for easy resolution (i. etc. Audit managers are able to efficiently and effectively control audit schedules.

MasterControl offers a validation approach that dramatically cuts the time. or +81 (03) 5422 6665 (Japan). For more information about MasterControl. pain.■■ Analytics and Reporting Tool: MasterControl’s powerful reporting capabilities include dashboard. has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize software ROI faster. and scheduling features. produces software solutions that enable regulated companies to get their products to market faster. drill-down. and electronic signature capabilities that fully satisfy FDA’s 21 CFR Part 11 requirements. site. audit management. +44 (0) 1256 325 949 (Europe).mastercontrol. ■■ Expert Product Training: MasterControl’s Professional Services team.800. ■■ Web-Based Platform: MasterControl is Web-based so it can connect all employees involved in the audit process from virtually anywhere. and flexibility to meet every customer’s needs. © 2015 MasterControl Inc. About MasterControl MasterControl Inc. supplier management. bill of materials. and more. consisting of former auditors and system administrators. MasterControl solutions include quality management. month. ■■ Part 11-Compliant Features: Provides time-stamped audit trail. while reducing overall costs and increasing internal efficiency.com. making it easier to stay compliant. from initial installation to regular maintenance. Alleviates IT and Project Management Concerns The MasterControl Audit solution has been designed to be easy to validate. easy to validate and easy to use. product lifecycle management. training management. and account lockout to stop unauthorized users from gaining system access. 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. as well as trend audits by auditor.825. Our software is known for being easy to implement. supplier/site. MasterControl provides our customers with a complete information management solution across the entire enterprise. and certification. implement. The Analytics tool can be used to trend audit observations by category. and cost involved in validation. DSAUXXUSENLT-07/15 MasterControl Audit™ . ■■ Technical Support: Choosing MasterControl means getting the necessary technical support to ensure project success. submissions management. MasterControl’s continuum of innovative products and services include the revolutionary MasterControl Transfer OQ. and maintain which makes life a lot easier for those tasked with rolling out an enterprise software system. ■■ Unparalleled Validation: For FDA-regulated companies. standard. or rating. document management/document control. password expiration. MasterControl securely manages a company’s critical information throughout the entire product lifecycle. or call: 1. Supported by a comprehensive array of services based on industry best practices.). Security features include dual passwords for document approval. MasterControl offers the expertise. Automation helps simplify the compliance environment.S.visit www. infrastructure.9117 (U. checklist criteria. encryption. reporting. All rights reserved.