CATSWeb® -- Quality & Compliance Should be a Given, Not a Goal

AssurX’s CATSWeb® is a flexible, all-in-one software solution that automates quality management, risk & regulatory compliance related processes so issues can be globally managed—from detection to corrective action to trend analysis. It helps collect, organize, analyze and share information to better manage and improve quality and compliance performance everywhere in your enterprise.

CATSWeb Enterprise-wide Quality and Compliance Management System
By providing clear views and shared information across functional areas, AssurX creates the power to easily detect, correct and analyze issues globally so companies can continuously improve operations, compliance and their bottom line. Click on any of the areas in the diagram to find out more...


Corrective & Preventive Action (CAPA) Workflows Best Practice CAPA Process Closed-loop corrective action tracking process is designed for companies following Good Manufacturing Practices (GMPs). Recurring issues are investigated, root causes identified, corrective/preventive actions implemented and evaluated for effectiveness.
*Benefits* Centralize CAPA Processing Reduce Problems Prevent Recurrences Prioritize Resources Reduce Costs Decrease Cycle Times Compliance (FDA, ISO, SOX, EMEA, NRC, etc.)	*Features* Root Cause Analysis Auto Escalation Executive Dashboards Configurable Reports Ad-Hoc Query Integration Tools Built-In Reporting 21 CFR Part 11 Compliant

Audit Management Best Practice Audit Process Comprehensive audit management process follows best practices for closed-loop findings; closure, task assignments and escalation. Audits are conducted after being planned, findings are classified and follow-up is assigned to area managers. After follow-up actions are addressed, a final report is issued and routed for closure.
*Benefits* Increase Audit Consistency Reduce Audit Cycle Times Meet Regulatory Requirements Reduce Errors & Missing Records Compliance (FDA, ISO,SOX, EMEA, NRC, etc.)	*Features* Internal & Supplier Audits EH&S, Facilities GXP, ISO, GAP, SOX Auto Notification, Escalation Ad-Hoc Query & Reporting Integration Tools 21 CFR Part 11 Compliant

Manufacturing Quality: Incidents, Requests, Corrective Action Best Practice Issue Management Comprehensive manufacturing quality tracking follows best practices from ISO and GMP standards. Includes closed-loop issue and change request management from initiation through disposition and corrective action. Track trends, cycle times and costs to facilitate root cause analysis and improve efficiencies.
*Benefits* Reduce Time To Market Increase Yields Continuous Improvement Facilitate Project Collaboration Reduce Development Costs Reduce Product Change Costs	*Features* Engineering Change Orders Project Management Prototype Issue Management Corrective/Preventive Action Auto Notification, Escalation Ad-Hoc Query & Reporting Audit Trail, E-Signatures

Procedures Management: Closed-loop Procedures Management Manage all documentation including policies, procedures and work instructions with CATSWeb. Implement revision control and change management with approval routings and email notifications. Disseminate notifications of document additions and changes based on affected roles.
*Benefits* Centralized Content Control Reduce Errors & Cycle Times Eliminate Wrong Document Use Increase Security, Control Access Lower Operating Costs Compliance (FDA, ISO,SOX, EMEA, NRC, etc.)	*Features* Document Repository Change & Revision Management Review & Approval Routing Training Notification Search Documents and Metadata Ad-Hoc Query & Reporting Integration Tools 21 CFR Part 11

Complaint Handling: Customer Event Management Automate all customer related events including complaints, returns, service calls and product improvement requests. Drive best practices process workflows based on event type and severity. Improve customer satisfaction and responsiveness with escalation management.
*Benefits* Increase Customer Satisfaction Increase Responsiveness Reduce Fields Failures Prevent Recurrences Reduce Recalls Meet Regulations (MDR, Vigilance, etc.)	*Features* Product Complaints, Returns Adverse Events Field Service Requests Improvement Suggestions Corrective/Preventive Action Auto Notification, Escalation Ad-Hoc Query & Reporting 21 CFR Part 11

Supplier Quality Management: Issue Tracking, Audits, Score Cards Improve supplier quality management and performance by tracking purchased product issues from receiving through manufacturing and into the field. Manage all aspects of supplier qualification and auditing. Assign findings, track follow-ups and issue reports. Consolidate supplier information and calculate supplier scores based on performance.
*Benefits* Increase Supplier Quality Improve On-Time Deliveries Reduce Shortages Reduce Correction Cycle Times Reduce Purchased Parts Costs Compliance (FDA, ISO,SOX, EMEA, NRC, etc.)	*Features* Manage Supplier Audits & Findings Supplier Score Cards Log Incoming Inspection Problems Track Late & Short Shipments Collaborate on Corrective Actions Auto Notification, Escalation Ad-Hoc Query & Reporting 21 CFR Part 11

Project & Change Management: Engineering Change Orders & Project Management Effectively manage continuous process improvements projects to update products and processes. Assign and manage tasks required to implement changes across all functional areas including manufacturing, purchasing and service. Also manage new product development projects and reduce time to market.
*Benefits* Reduce Time To Market Increase Yields Continuous Improvement Facilitate Project Collaboration Reduce Development Costs Reduce Product Change Costs	*Features* Engineering Change Orders Project Management Prototype Issue Management Corrective/Preventive Action AutoNotification, Escalation Ad-Hoc Query & Reporting Audit Trail, E-Signatures