QAssure™ product from QAtor solves for the first time, in a simple and cost effective way, the critical compliance issues faced by Life Science companies in managing their Quality Assurance processes and ensuring that their GxP regulated documentation is always up to date and compliant.

The application places emphasis on control, efficiency and traceability early in the compliance management process, and will pay back in savings of time and cost of quality in the end of process. With QAssure™ the compliance management efforts can be focused on the most critical issues at the most appropriate time leading to minimized interruptions to production and maximized operational efficiency. The professionals involved in GxP regulated projects can edit, review, and approve documents faster than ever before and shorten the cycle without decreasing quality.

Tools for Managing GxP Projects, Documents and Workflows
QAssure™ provides a complete set of tools for managing compliance projects, documents and workflows according to GxP regulations. QAssure™ is a fully Web-based application giving authorized internal users and selected external contractors a secure access to your company’s specific project or Quality Assurance information anywhere, anytime simply through a browser. The system allows controlled editing, commenting and approving updated documentation in real time, thus simplifying today’s paper, email and Word based processes and virtually eliminating the need of passing draft documents around on paper.

For new projects QAssure™ will automatically generate draft documents according to project templates selected from best practices library. Project flow compliance control ensures that previous documents in the project flow will obtain required signatures from its assigned users before letting the next documents in the project flow to be approved.
QAssure™ meets the FDA’s 21 CFR Part 11 regulations for electronic records, electronic signatures, complete audit trails with strong role-based data security model and comprehensive archiving. Its critical business process workflows allow you to fully enforce the compliance of GxP regulations in accordance with your specific business needs.

Management of not only individual documents, but also information inside and across documents or processes is becoming ever increasingly important
QAtor’s unique technology allows Life Science companies to create and manage Compliance Documentation as Structured Documents. The solution ensures full traceability across documents (i.e. URS, IQ, OQ, PQ) instead of only managing unstructured documents in traditional document management systems and tracing versions of information within the same document (i.e. URS-v01 vs. URS-v02). The technology is specifically designed to help in creating, linking and tracking compliance information inside and across any document or protocol. At the same time compliance with FDA and GxP regulations governing pharmaceutical manufacturing is always ensured and company can be confident of covering all requirements whenever inspected.

QAssure™ lowers your Total Cost of Quality while ensuring that GxP compliance is kept at the highest level at all times.

Reuse the Past Regulatory Compliance Know-how
QAssure™ also links directly between your organizational know-how (i.e. test cases and observed deviations) and present work in progress, thus attempts to reuse your compliance documentation. User can instantly understand the potential future implications based on the past validation know-how. In short, learn from past mistakes and ensure that your quality improvement process really starts in the specification phase.

QAssure™ and Risk-based Approach
Recent regulatory initiatives from the FDA and other regulatory authorities have raised new challenges, as well as opportunities, especially with risk-based approaches to compliance. As a result the risks of product quality, information systems, and patient safety must be taken into account throughout the industry.

The Risk-based Approach is achieved by a combination of validated, well-documented systems, together with the compliance applications appropriate to control the impact of the systems or processes concerned including risks assessments for each of them.
QAssure™ has a built-in Risk Assessment module to support the risk based approaches. The specific application module with unique ability to track information across GxP document and flag risk parameters gives you a powerful tool to manage your risk assessments.

QAssure™ with Risk-based Approach raises opportunity to determine the scope and extent of validation leading to saving dramatically from currently exaggerated compliance efforts in the areas determined as low impact or no impact on product quality or patient safety.

Accelerated Validation Process
Compared to traditional paper-based validation and commissioning process, QAssure™ reduces significantly commissioning and validation time. Reduced time can mean an earlier startup, and therefore more revenue.

With QAssure™ validation scope has been decided early in the process with Risk Assessments to avoid unnecessary work. During the validation several instrument technicians can work in the field, while project manager can follow progress from his office or control room. The control room becomes centralized place not only for running the manufacturing process but also tracking the commissioning and validation activities.

Time and resources needed for Computer System Validation can be reduced even more by executing most of the validation activities remotely over a computer network. Verification results and observations from validation activities can be captured directly into QAssure™ with smart screen capturing and GxP compliant multi-layer annotation tool.

Electronic validation and commissioning process ensures not only savings in time and cost but also better collaboration, project visibility, secure and undisputable audit trails of electronic signatures in compliance with FDA’s 21 CFR Part 11.

Support for Increased Globalization
Regulatory and safety functions are good examples of increasingly global functions in Life Science Industry. Regulatory compliance and validation projects can now benefit from re-using regulatory information from other sites and previous projects or reaching Subject Matter Experts remotely whenever necessary.

Increasing need for global reach is supported by Web-based applications. A single Web-based Compliance Management Application can provide many users, in several locations, access levels and roles, both global standards and local specific business processes.

Status and Statistics of GxP Compliance Projects
Companies need a formal way to surface compliance issues, report on the progress, and have them come to the attention of the right personnel in the organization to permanently address them. Whether regulatory compliance problems are identified internally or through regulatory inspections, strategically approaching the problems is essential. Therefore, a formal compliance management and project tracking system is necessary to add visibility and measure progress of project teams.

QAssure™ provides project transparency by tracking both actual status and statistics of GxP compliance projects, percentage completed through the document lifecycle and tasks related to project deliverables. The status monitoring has been made easy to measure progress of project teams and only intervene when necessary.

QAssure™ manages document review process with standard review notes to trace repeated issues in documentation process and improve quality. QAssure™ also facilitates the process of creating deviations and change requests in accordance with GxP leading to easy tracking of status and accelerated close out. The information provided by QAssure™ allows proactive project management to avoid delays hence reducing cost of quality and making project management more efficient.

Key Features

• Smart structured compliance document and requirements management with built-in Risk Assessments
• Traceability across documents and automatically generated traceability matrix
• Enhanced document reviews with controlled online comments for easy processing and statistics
• Compliance project management with document schedule, standard workflows and task monitoring
• Implements 21 CFR Part 11 compliant access control, audit rail, electronic signatures, version control and archiving functions
• Deviations traced automatically if verification steps in validation protocols fail
• Impact of Change is visible to decide on Change Requests
• Smart image capturing with integrated and GxP compliant multi-layer image annotation tool

Benefits for Life Science Companies


• Ensures GxP compliance by capturing progressively compliance and validation documentation
• Improves quality, adds transparency, helps to identify and address regulatory concerns and compliance issues faster
• Instantly puts GxP processes and projects “in control” with faster electronic workflows accelerating time-to-market and reducing cost of quality
• Provides real-time visibility into statistics and key performance indicators (KPI’s) of quality assurance and compliance tasks
• Eliminates highly expensive routine work from your Quality Assurance compliance and verification process by automating routine tasks
• Ensures full control and audit trail over GxP compliance documents and projects
• Improves project communication with various contractors and suppliers to meet tight commissioning and validation schedules
• Scales from a small QA teams to an enterprise-wide Quality Assurance Center of Excellence thus easy to deploy global Quality Assurance standards
• Good templates to improve level of compliance or reduce time to become GxP compliant

Use QAssure™ to dramatically save from currently exaggerated compliance efforts

 

System Requirements


• CLIENTS: Microsoft Internet Explorer v6.0™ and Adobe Reader™
• SERVER: Oracle Database v10g or higher

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