Medical Audit

Meets ISO 13485 and 21 CFR Part 820-Compliant Quality Standards for a Medical Audit

A quality audit is necessary in evaluating the state of a company's quality system. In the FDA environment, quality audits are required to help improve product quality and safety and to ensure compliance.

Select the type of audits that apply to you:

  GLP Audits, GCP Audits, PV Audits, Vendor Audits, Supplier Audits

  General Quality Audits, ISO Audits, GMP Audits

The Quality System Regulation ( 21 CFR Part 820 ) requires medical device companies to monitor their quality systems through audits. Under the Current Good Manufacturing Practice (CGMP) principles outlined in QSR, quality audits are considered a necessary part of a self-correcting quality system.

For ISO-certified medical device manufacturers, ISO 9000 requires evaluation of the quality system and examination of audit results by management, while ISO 14000 calls for internal environmental management audits. ISO13485 requires companies to conduct an internal audit (or a medical audit) on a regular basis as a way of monitoring and measuring quality.

The MasterControl integrated quality management suite is a configurable and easy-to-use software solution that helps medical device companies attain and sustain CGMP and ISO compliance. Recognizing that validating a software solution (as required by 21 CFR Part 11 ) is a necessary component in FDA compliance, MasterControl offers comprehensive, full-cycle validation services, including IQ, OQ, and PQ validation tests. MasterControl continuously develops new methods to cut the time involved in validating a system and to make it easier to validate software upgrades, both of which are essential in lowering overall validation cost.

How can MasterControl Audit™ Benefit You?

The MasterControl Audit software solution can help medical device manufacturers attain and maintain CGMP compliance by automating, streamlining, and effectively managing the processes associated with a quality audit and/or medical audit. Here's how the MasterControl Audit software solution addresses some of the major challenges of both performance and compliance audits.

Quality Audit Management Challenges		MasterControl QAAD Audit™ Solution
Inefficient Audit Tracking In a manual system, tracking audit findings, related corrective/preventive actions (CAPAs), and re-audits is an overwhelming task. The more frequently a company conducts a medical audit, the more difficult it is to track correlated audit documentation.		Efficient Audit Tracking Provides a centralized Web-based repository for all audit documentation that makes search and retrieval easy. It provides advanced tracking capability every step of the way, from scheduling and planning to execution to completion. It offers best-practice audit forms for tracking basic audit information (scope, checklists, audit team, audit status, etc.) and information for each finding. It can be integrated with the CAPA process to track related CAPAs.
Poor Scheduling Auditing is a recurring process. The types of medical 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 audits.		Efficient Scheduling Automates scheduling of all recurring audit-related activities so they won't be overlooked. Allows planning and scheduling of tasks well in advance.
Poor Follow-up Assigning team members and following up tasks via e-mail or phone is a time-consuming process that could easily fall through the cracks.		Efficient Follow-up Automates task assignment and follow-up for a medical audit via automatic e-mail notification. It incorporates escalation capability for any task not completed by deadline.
Lack of Oversight It's difficult to generate accurate and timely reports and trends using disparate tools (electronic spreadsheets, flowcharting software, paper documents in binders). Without an effective reporting tool, managers are unable to get the big picture of their program for conducting a medical audit.		Increased Oversight Provides advanced 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 their quality system.

Features

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 medical 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 audit process, as well as streamline 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 a medical 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 audit process by providing a powerful scheduling feature. All recurring tasks related to a medical 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:

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

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

• Findings by root cause.

• 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).

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

• Open 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 quality audit system 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 medical 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.

For More Information

For more information about a medical audit or audit software for conducting an internal audit, please don't hesitate to contact a MasterControl representative.