MasterControl QAAD - Regulatory Inspections

Software System for Regulatory Inspections and for Automating Other Regulated Quality Processes

Regulatory inspections provide companies with opportunities to monitor critical processes, rectify problems, and improve overall quality. To do so, however, an efficient, integrated quality management system must be in place. With an electronic, integrated quality system such as MasterControl QAAD™, companies can manage findings by regulatory inspectors and monitor CAPA implementation.

MasterControl QAAD captures and maintains information on inspections (performed at any site) in a single, unified system, and allows users to track all outstanding actions.

MasterControl QAAD improves processes related to external inspections by:

• Focusing on key inspection areas to identify 'high risk areas’
• Managing all inspection-related information in a secure electronic repository
• Facilitating compliance with regulatory standards and requirements
• Providing a global view, so that management can focus more effectively on specific quality problems and take optimal action
• Tracking corrective actions to completion, thereby closing the 'quality cycle'
• Identifying strengths and weaknesses to better assess training and resource efforts

Features and Benefits of the MasterControl QAAD Quality Software Solution for Regulatory Inspections

Life sciences: MasterControl QAAD is the demonstrated leader in provision of solutions for research and development quality groups in highly regulated industries. More than half of the top 20 pharmaceutical companies alone rely on MasterControl QAAD for their quality management within R&D groups.

Consolidated: MasterControl QAAD unites all quality programs into a single comprehensive system, enabling validation and support efforts to be shared across an organization. The solution provides maximum flexibility without the need for vendor intervention, external consultants, or additional programming. MasterControl QAAD includes all the necessary tools within the standard off-the-shelf product—users decide which features to use without being required to purchase costly add-on options.

Cost effective: MasterControl QAAD is intuitive and reduces training time, bringing a rapid return on investment at an amazingly low total cost of ownership. Staff resources are optimized by the MasterControl QAAD solution's scheduling and planning tools.

Compliant: MasterControl QAAD is fully compliant with U.S. 21 CFR Part 11. Specific functionalities related to GLP, GCP, GMP are included within the standard off-the-shelf product. The comprehensive solution is based on a flexible access security model, and provides crucial compliance-oriented features such as audit trails and electronic signatures.

Flexible: MasterControl QAAD has core business processes available “out of the box” and predefined workflows that users can either modify or utilize to create a completely new workflow. This means that you can easily update the system to conform with your procedures without using consultants. This contributes to keeping ownership costs low.

Electronic Tracking and Distribution: A paperless solution, MasterControl QAAD incorporates full electronic activity recording and distribution features, including response receipt and CAPA tracking.

Robust Reporting Tools: MasterControl QAAD comes with data trending, metrics, and compliance surveillance tools to help monitor quality and compliance statuses. The solution incorporates trending/metrics data, risk assessment and root cause analysis to increase the overall effectiveness of quality and compliance surveillance.

Language Translation Tools: The system's language capabilities can translate dictionary data and display system field labels in the user's local language (using either single or multi-byte characters).

Reduced Implementation Time: Business processes are pre-mapped in the standard off-the-shelf product, reducing the time needed to implement the software.

About MasterControl QAAD  
MasterControl’s QAAD software solution is a user-configurable, validated, off-the-shelf tool designed and developed by QA, for QA. Whether your company is a small start-up, a division of a larger organization, or a corporate group, we understand your business. Regardless of the organization's size, users can configure MasterControl QAAD to effectively manage quality, compliance and CAPA programs. Versatile tools allow users to manage dictionary terminology, create custom screen labels, configure workflows, and design templates.

If your organization is responsible for GLP, GCP, GMP, environmental audits, vendor management, and/or Pharmacovigilance/product safety audits, MasterControl QAAD can be deployed as a local or global solution to meet all your audit needs. The MasterControl QAAD solution provides a centralized database that can be used in one or more areas with as much or as little sharing of workflows and dictionary data as the user requires. The solution harmonizes processes between audit groups and across audit groups. By having built-in regulatory requirements (i.e., GLP multi-site study capabilities, QA statements, a GLP master schedule, audit certificates, as well as batch release, “qualified person” tools, supplier evaluation, clinical trial monitoring and key data capture) MasterControl QAAD meets the specific needs of all research and development quality groups.

MasterControl QAAD gives companies the freedom of automated processes, replacing inefficient paper-based systems with an electronic system that allows users to:

• Create quality and compliance plans
• Manage resources and projects
• Write quality and compliance findings directly into the database
• Perform peer review/approval prior to issuing reports
• Electronically issue results to a document or web browser
• Remotely record findings

The MasterControl QAAD solution's web-based response features allow personnel to electronically receive findings and comments, respond to them, and track the status of individual CAPAs. Workflows can be configured to manage follow-up and implementation status, with email reminders automatically generated as due dates approach.

Numerous standard reports, as well as an ad-hoc query tool, provide compliance trend and metric analyses, CAPA status, and the status of studies, projects and activities. Security features, audit trails, and compliance with U.S. 21 CFR Part 11 are all standard features. Global deployment is simplified by the system's multiple language capabilities, which include single- and multi-byte characters.

Related Items:

• FDA GLP Regulations for Non-Clinical Laboratory (21 CFR: Part 58)
• GLP Statutory Instrument
• OECD Revised GLPs
• GPO Access Online CFR