Internal Quality Audit


Why is either MasterControl Audit™ or MasterControl QAAD™ Right for You?

MasterControl Audit™ and MasterControl QAAD™ are both integrated parts of the MasterControl quality suite. Both solutions automate and manage the audit process in an efficient and cost-effective manner.

This page describes some of the key factors for an internal quality audit from MasterControl for ensuring that your system is always Compliant, Connected, and Complete.

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

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Compliant.

Sustained Compliance: MasterControl's audit software solutions not only help companies attain ISO and FDA compliance, but help sustain it by optimizing quality processes and keeping the quality system always ready for internal audits as well as 3rd-party performance and compliance audits.

  • Increased Efficiency Through Automation: MasterControl's software solutions for an internal quality audit automate 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 Electronic Forms: The MasterControl audit software for an internal quality audit provides important forms for collecting and tracking data throughout the audit process. Additional forms can be configured based on the company's unique needs.

  • Centralized Repository: All audit-related documents will be stored in a secure, centralized repository, making it easy to search and retrieve them during ISO, customer or internal audits.

  • Analytics and Reporting: MasterControl Audit software's advanced analytics and reporting capability increases management oversight. It provides the ability to dynamically capture, trend and link data needed to solve problems and improve processes. Standard audit reports include audit summary, audit detail, findings by root cause, audits by standards, audits by auditor, and open findings. In addition to these and other standard reports provided by the solutions for performing an internal quality audit, MasterControl QAAD provides the GLP-required Master Schedule and QA Statement, and the GCP Compliance Statement.

  • Revision Control: MasterControl's "check out" and "check in" feature provides automatic revision control to ensure that only current version of a document is available. When a user makes a change in the InfoCard (the MasterControl tool that provides basic information for every record), the user must enter a reason for the change. The software tracks all changes made to the InfoCard.

  • Advanced Scheduling: 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.

Connected.

Integrated Quality Management: The solutions from MasterControl for an internal quality audit connect the internal audit process with other quality processes for a holistic approach to quality management.

  • Integrated Process: MasterControl streamlines the internal audit process by integrating the different steps (preparation, scheduling, execution, findings, verification, and completion).

  • Easy Access: MasterControl is Web-based so it can connect employees, suppliers, contractors, and others involved in the audit process regardless of location.

  • Form-to-Form Launching: A corrective and preventive action (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.

  • Dependent Routing: 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. This can greatly speed up the process for an internal quality audit. An innovative dependency tree illustrates relationships between dependent processes.

Complete.

Enterprise-wide Product Application: MasterControl Audit can handle every department's forms - and documents-based processes, making it an ideal enterprise-wide solution.

  • Integrates with Other Applications: The solutions from MasterControl for an internal quality audit can integrate with other applications like ERP, LIMS, accounting, and human resources applications to accommodate departmental needs.

  • Easy to Search: A standardized Google-like search window is available throughout the application, which means all authorized users throughout the organization can search and retrieve change control-related tasks and documents.

  • Easy to Find: MasterControl's Organizer, similar to Windows Explorer, is an easy-to-use tool that helps users find and access documents quickly. Every department can maintain its own Organizers and documents can be stored in multiple Organizers. System administrators can control and automatically update the documents through a dynamic link in the InfoCard.

  • Automation of Forms-Based Processes: Any forms-based process unique to a department (such as application forms for HR, customer satisfaction survey forms for Customer Service Department) can be automated. A department can keep the look and function of existing forms or create entirely new ones.





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