Under the Current Good Manufacturing Practice regulations found in 21 CFR Parts 210-211 (Section 211.180), pharmaceutical companies are required to review the quality standards of each drug product on an annual basis. In addition, the FDA's guidance, the Quality Systems Approach to Pharmaceutical CGMP Regulations, calls for an internal audit at planned intervals to evaluate effective implementation and maintenance of the quality system.

The MasterControl integrated quality management suite is a configurable and easy-to-use software solution that helps pharmaceutical companies attain and sustain CGMP compliance. Recognizing that validating a software solution (as required by 21 CFR Part 11 ) is a necessary component in FDA compliance, MasterControl provides Transfer OQ (in the form of transfer operational qualification or TOQ). TOQ provides completed validation and supporting documentation of IQ/OQ tests performed at MasterControl. This documentation serves as evidence that the functions of a MasterControl application perform correctly against specifications. MasterControl TOQ saves companies time and money by reducing the overall validation burden, and is a key component of MasterControl's continuous validation approach. As part of this solution, a MasterControl validation expert will perform a comprehensive validation risk assessment.

Quality Management Challenges for a Pharmaceutical Audit		MasterControl QAAD™ Audit Solution
Inefficient Pharmaceutical Audit Tracking In a manual system, tracking the findings associated with a pharmaceutical audit, related corrective/preventive actions (CAPAs), and re-audits is an overwhelming task. The more frequent audits are conducted, the more difficult it is to track correlated audit documentation.		Efficient Audit Tracking MasterControl's software solution for a pharmaceutical audit provides a centralized Web-based repository for all of the documentation that facilitates a search and retrieval operation for a pharmaceutical audit. The software 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 Pharmaceutical audits are iterative. The types of a pharmaceutical 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 This automates scheduling of all recurring audit-related activities so they won't be overlooked. It allows planning and scheduling of the tasks that are involved well in advance of the pharmaceutical audit.
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 audit task assignment and follow-up via automatic email 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 pharmaceutical audit program.		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 QAAD Audit™ is a complete and robust solution that integrates the different steps (preparation, scheduling, execution, findings, verification, and completion) necessary for a successful 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 pharmaceutical 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 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 audit process - by providing a powerful scheduling feature. All recurring tasks related to a pharmaceutical 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 QAAD 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.

For More Information

For more information about processes involved in a pharmaceutical audit that is efficient, please feel free to contact a MasterControl representative.