Compliant. Connected. Complete.

MasterControl Audit™
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.

How can MasterControl help 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. MasterControl offers a line of validation products and services addressing different levels of validation needs based on individual risk assessment. They are designed to allow “continuous validation” for FDA-regulated companies by making validation of software upgrades easier, faster, and more cost-effective. Here’s how MasterControl addresses common challenges of both performance and compliance audits:

Challenges Disconnected: 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. Inefficient Scheduling: Audit is a recurring process. The types of 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. 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.

MasterControl Solution Connected: 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.

Advance Scheduling: Automates scheduling of all recurring audit-related activities so they won’t be overlooked. Allows planning and scheduling of tasks well in advance.

Increases Visibility: Provides powerful analytics and reporting capability, including customizable reports and online charting. Through the reports, managers get a realtime view of the audit process and can be more proactive about improving the quality system.

Compliant: MasterControl allows continuous compliance by keeping your quality system always ready for inspections and audits. • • Automates Tasks: Automates all tasks pertaining to the audit process, including notification, follow-up, and escalation of overdue assignments. Automation helps simplify the compliance environment, making it easier to stay compliant. Best-Practice Audit Forms: MasterControl provides two important forms for collecting and tracking data. • Audit Summary: This form 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.

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Compliant. Connected. Complete. ™
• 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 ensures proper closure by tracking verification of the process owner’s response to the finding.

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Advance Scheduling and Routing: All recurring tasks related to an audit can be scheduled in advance so they will not be overlooked. This capability eliminates the need to remember to launch tasks manually. Analytics and Reporting Tool: MasterControl’s powerful reporting capabilities include dashboard, drill-down, and scheduling features, and 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 (e.g., FDA GMP Part 820.22). Audits by Auditor: Lists audits categorized by the auditors conducting them. Open Findings: Lists open findings categorized by owners.

Part 11-Compliant Features: Provides time-stamped audit trail, reporting, and electronic signature capabilities that fully satisfy FDA’s 21 CFR Part 11 requirements. Security features include dual passwords for document approval; password expiration, encryption, and certification; and account lockout to stop unauthorized users from gaining system access.

Connected: MasterControl Audit connects the audit process with the rest of the quality system to promote continuous improvement. • • Web-based Platform: MasterControl is Web-based so it can connect all employees involved in audit from virtually anywhere. Form-to-Form Launching: A CAPA form can be launched directly from another form, such as an Audit Finding form. 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. Links are maintained so users can review a completed process and see what triggered the CAPA. Integrates with Existing Applications: Integrates with existing document repositories and enterprise applications like ERP, LIMS, etc., without expensive custom coding. Organizers: MasterControl’s Organizer, similar to Windows Explorer, is an easy-to-use tool for grouping audits by area, or location, or standard/regulation. Users will have access to Organizers related to their jobs, connecting them directly with data they need.

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Complete: MasterControl offers robust software, plus the appropriate tools and services necessary for successful implementation and validation. • Continuous Validation: For FDA-regulated companies, MasterControl offers a “continuous validation” approach that dramatically cuts the time, pain, and cost involved in validation. MasterControl’s continuum of innovative products and services include MasterControl Transfer OQ and MasterControl Automated OQ. Product Training: MasterControl’s Professional Services team, consisting of former ISO auditors and system administrators, has developed a comprehensive training program that serves as a foundation for successful project implementation and helps companies realize software ROI faster. Technical Support: Choosing MasterControl means getting the necessary technical support to ensure project success. MasterControl offers the expertise, infrastructure, and flexibility to meet every customer’s needs, from initial installation to regular maintenance.

6322 S. 3000 E. Suite 110 Salt Lake City, UT 84121

P 800.825.9117

F 801.942.7088

MASTERCONTROL.COM

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