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, quality audits are required to help improve product quality and safety and to ensure compliance. MasterControl Audit Essentials was designed to streamline the quality audit process while helping to ensure FDA and ISO compliance.
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MasterControl Audit Essentials™, an integrated part of the MasterControl™ quality suite, is an easy-to-use software solution that automates, streamlines, and effectively manages the quality audit processes.
Here's how the Audit Essentials solution from MasterControl addresses common challenges:
Quality Audit Challenges
MasterControl Audit Essentials™ Software Solution
|Disconnected Quality Audit Processes
For regulated companies, audit findings may lead to corrective/preventive actions (CAPAs). But in manual systems, the quality 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 quality 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 depends 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 AuditsAutomates 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 quality audit process and can be more proactive about improving the quality system.
MasterControl's Audit Essentials software for quality audits 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 quality audits. This streamlines the workflow to promote efficiency. Additional forms can be configured based on the company's unique needs.
Quality 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 quality audits, audit agenda, audit team members, and checklists.
Audit Finding - This form tracks all the findings resulting from the quality 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 audits 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 quality 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 which ultimately leads to effective quality audits. 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 quality 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 quality 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 quality audits is generally a good indicator of overall compliance. MasterControl Audit Essentials 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 and ensure quality audits .
To learn more about MasterControl's Audit Essentials software, please contact us online.