Quality Audit

Our System for a Quality Audit, MasterControl Audit™, Ensures Quality and a Continuous State of "Audit Preparedness".

A quality audit is to a regulated company what a medical examination is to a patient. It is a necessary procedure for evaluating a quality system’s general "health" and for "diagnosing" problems in order to correct them. In the FDA and ISO environments, a quality audit is required to help improve product quality and safety—and to ensure compliance.

Watch Audit Automation Videos Passing Audits and Inspections with MasterControl (3:08) How MasterControl Makes Your Job Easier (3:50)

Free Quality Audit White Papers and Audit Solutions
	White Paper: Quality Audit - A Tool for Continuous Improvement and Compliance
	White Paper: The Top 5 Benefits of Electronic GLP Audit Management
	Webinar: Automating Quality Audits for Regulatory Compliance
	Interactive and Live Demonstration: MasterControl Quality Suite Demonstration

How Can the Software from MasterControl for a Quality Audit Benefit You?

MasterControl Audit™, an integrated part of the MasterControl™ quality suite, is an easy-to-use software solution that automates, streamlines, and effectively manages the audit process.

Here's how the solution from MasterControl for performing a quality audit addresses common challenges:

Quality Audit Challenges		MasterControl Audit™ -- Software Solution for Ensuring a Quality Audit
Disconnected Quality Audit Processes For regulated companies, audit findings may lead to corrective/preventive actions (CAPAs). But in manual systems, the audit process is not connected to CAPA. Disconnected processes could mean poor data collection and slower CAPA and change implementation.		Connected Quality Audit Processes Connects the audit process with the rest of the quality system for a holistic approach to quality management. A CAPA form can be launched directly from an audit finding form, greatly streamlining the process.
Inefficient Scheduling of Quality Audits Quality audit processes are recurring. The types of quality audit (internal, customer, compliance) conducted and their frequency depend on company size and nature of business. Manual scheduling can be a major stumbling block especially for companies with numerous quality audits.		Easier, Advanced Scheduling of Quality Audits Automates scheduling of all recurring activities related to a quality audit, to ensure that they won’t be overlooked. Allows planning and scheduling of tasks well in advance.
Quality Audit 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 quality audit programs.		Increases Visibility of Quality Audits Provides powerful analytics and reporting capability, 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.

MasterControl Audit™ - Software Features for Performing a Quality Audit

MasterControl Audit is a complete and robust solution that integrates the different steps (preparation, scheduling, execution, findings, verification, and completion) necessary for the success of a quality audit. MasterControl is 100 percent Web-based so auditors and other users can access it from virtually anywhere. Here are some of its powerful features:

Best-Practice Forms – MasterControl provides two important forms to help collect and track data throughout the process for a quality audit. This streamlines the workflow to promote efficiency. Additional forms can be configured based on the company's unique needs.

• Audit Summary - This form is essential in planning and preparing for an audit. It tracks basic information about an audit: type of audit, date, description, objective, scope, audit area, and lead auditor. It is also the tool for gathering such information as: standard or regulation that serves as the basis for the audit, audit agenda, audit team members, and checklists.

• Audit Finding - This form tracks all the findings resulting from the audit. It integrates risk management by providing a section for evaluating risks and gathering the following information: risk category, severity, risk of recurrence, and whether CAPA is required. It also ensures proper closure by tracking verification of the process owner's response to the finding.

Connected Quality Processes - MasterControl recognizes that a "healthy" and compliant quality system must have well-functioning subsystems that are connected to each other. MasterControl's holistic approach gives you the capability to launch a CAPA form directly from the Audit Finding form, connecting one process to the next. Not only does MasterControl streamline this process, but it also maintains the links so one can review a completed process and easily see what triggered that process. Pertinent information from the Audit Finding form will be automatically entered into the CAPA form, reducing data entry. It also shows the history of the entire process.

Advanced Scheduling and Routing - MasterControl addresses recurrence, a unique characteristic of the quality audit process, by providing a powerful scheduling feature. All recurring tasks related to a quality audit can be scheduled in advance so they will not be overlooked. This capability eliminates the need to remember to launch tasks manually. Completion of a task can be made dependent on another task to give managers more control of the workflow and reduce cycle time by prompting users immediately to their next task. An innovative dependency tree illustrates relationships between dependent processes.

Analytics and Reporting Tool - MasterControl's advanced reporting capabilities include the following customizable reports:

• Quality Audit Summary - Gives a concise view of all the in-process audits and their status, as well as future audits.

• Quality Audit Detail - Gives a detailed view of the findings associated with the quality audit, including related CAPAs.

• Findings by root cause.

• Quality Audits by Standards - Lists audits categorized by standard (i.e., ISO 9001:2000, Sec. 8.2.2) or by regulation (i.e., FDA GMP Part 820.22).

• Quality Audits by Auditor - Lists audits categorized by the auditors conducting them.

• Open Quality Audit Findings - Lists open findings categorized by owners.

Organizers with Virtual Folders - MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use and dynamic tool for grouping audits by area, or location, or standard/regulation. Through the Organizers, users can find and access documents quickly. They can create virtual folders within Organizers that will automatically retrieve documents based on pre-defined queries.

Sustained Compliance - An effective system for a quality audit is generally a good indicator of overall compliance. MasterControl Audit is designed not only to help you attain FDA and ISO compliance, but to sustain it by streamlining your audit program, fostering efficiency throughout the enterprise, and keeping compliance costs down. A quality system changes as a company grows and its products, operations, and employees change. With MasterControl, you can count on a partner that will support your compliance efforts over the long haul.

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