AssurX Makes Quality & Compliance a Given Not Just a Goal

AssurX Makes Quality & Compliance a Given Not Just a Goal TRACK. MANAGE. AUTOMATE. IMPROVE. AssurX s powerfully flexible software unites and coordinates information, activities and documentation in one reliable system, effectively managing any quality- or compliance-related operations. The easiest on the market to deploy, configure, use and adapt, AssurX is ideal for every business of any size even the most highly regulated. The software links and organizes quality and compliance data and history with schedules; tasks and activities; and compliance requirements and evidence across an organization. It automatically tracks and communicates about activities sharing the right information with the right people at the right time and coordinates efforts between groups. Using AssurX, you re always in control of activities and data; you know immediately when issues that could impact quality or compliance arise; and the appropriate staff shares the information needed to quickly evaluate and resolve problems. Powerful trending and analytical tools allow companies to identify and remediate risk exposure, avoid quality or noncompliance problems, and improve operations. With decades of expertise built into their solutions, AssurX helps companies exceed quality expectations, ensure compliance, manage risks and better govern their enterprise. Providing clear views of coordinated activities and information across all areas of a business, AssurX delivers the power to easily orchestrate operations; detect, correct and prevent problems; and improve quality, compliance and your bottom line. Whatever You Make, AssurX Makes it Easier for You Especially well suited for complex operations, distributed, and rapidly growing or changing businesses, AssurX excels in every industry. Solutions are preconfigured to work within each industry s best practices and regulations, and perform in a range of markets including: energy & utilities biotechnology food & beverage semiconductor pharmaceutical contract manufacturing finance insurance medical device consumer goods aerospace high technology

A FLEXIBLE SYSTEM OF SEAMLESSLY INTEGRATED SOLUTIONS The system is built on AssurX s core product platform, CATSWeb, the industry s leading true zero-client technology. Each solution combines unique functionality sets and workflows (based on industry best practices) with the core platform. The applications seamlessly integrate creating a single system for managing any quality and compliance related operations across an organization. Automate These and More With AssurX: Corrective & Preventive Action (CAPA) Closed-loop corrective action tracking for any industry. Issues from anywhere in your operations are investigated, root causes identified, corrective/preventive actions implemented and evaluated for effectiveness. Follows GMP and best practices. Audit Management Robust audit management process for closed-loop findings, task assignments and escalation, and closure. 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. Manufacturing Quality Comprehensive quality, nonconformance and defect tracking follows ISO and GMP standards for best practices. Get solid 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 efficiency. Supplier Quality Improve supplier quality management and performance by tracking purchased product issues from receiving through manufacturing and into the field. Manage supplier qualification and auditing. Assign findings, track follow-ups and issue reports. Consolidate supplier information and calculate supplier scores based on performance. Document Management Controlled management of all documentation such as policies, procedures, training and work instructions. Implement revision control and change management with approval routings and email notifications. Disseminate notifications of document additions and changes based on affected roles. Risk Management Identify, evaluate and prioritize corporate risks. Create and implement detailed mitigation plans and track their status through completion. Monitor key risk indicators across the organization. The software calculates probability, and uses both qualitative and quantitative evaluation to generate scoring/ grading scales. Regulatory & Standards Compliance Management No matter how heavily regulated the business from FDA monitored industries to energy and finance AssurX keeps you compliant with up to the minute regulations and standards. FDA COMPLIANT: 21 CFR Part 11, Part 820, cgxp, ISO and more. NERC & FERC COMPLIANT: All Electric Reliability Standards. HIPAA COMPLIANT: DHHS Health Data Protection regulations. FINANCIAL REGULATIONS COMPLIANT: Sarbanes-Oxley, US Patriot Act, and more. Development & Change Management Effectively manage operational change, continuous process improvement and new product development projects to reduce time to market. Easily assign and manage tasks required to implement changes across all functional areas including engineering, manufacturing, purchasing and service. Customer Quality Automate the processing of customer/product related events including complaints, returns, service calls and product improvement requests. Drive workflow based on event type and severity. Improve customer satisfaction and responsiveness with escalation management. Training Management Identify and manage training requirements, activities and materials by group or individual. Ensure all training and certifications are being completed in a timely manner. Easily record, retrieve and report on individual training histories. Product Event / Complaint Handling Streamline the proper processing, documenting and reporting of every complaint, from event intake through root cause analysis and resolution. Events are logged from any source, investigations conducted, reporting requirements assessed, and follow-up tasks assigned and tracked. Automatically launch corrective actions and electronic medical device reporting.

WHY ASSURX AssurX is a uniquely configurable and adaptable software system. It easily adjusts to fit any established or changing process, requirement or business. Mapping precisely to your real-world operations, the software creates an electronic workflow of tasks, alerts, escalations and approvals that can be automated to the level you prefer. It is available as either traditional OnPremise (licensed software) or OnDemand (SaaS). Easy In, Easy Up-and-running AssurX software is incredibly quick and simple to setup and deploy. Ready to use processes such as corrective actions, complaint handling, regulatory reporting, issue tracking, audits, document management, and supplier quality are provided with full documentation, validation scripts, template forms, management dashboards, and everything else needed for fast deployment. NO CLIENT SIDE SOFTWARE OR VALIDATION with a fast, easy server installation. INCLUDES READY TO USE WORKFLOWS & FORMS RAPID CUSTOM DEPLOYMENT WITH EASY POINT-AND-CLICK CONFIGURATION of workflows, forms, rules, lists, approvals, etc. No programming required. MINIMAL TRAINING NEEDED FOR USERS through a clean, intuitive interface and robust help and tutorials. ONDEMAND OPTION lets you Manage your Business, Not your Software. And, it gives the flexible option of bringing the system in-house at anytime. Management Dashboards, KPIs and Metrics Globally monitor key performance indicators and drill down to the underlying data in real time, all the time to improve operations, governance, risk exposure and the bottom line. Identify recurring problems and track trends, cycle times, costing and risk for the entire enterprise, by site, product, or any other parameter. BUILT-IN REPORTS DASHBOARDS, dashboard templates and metrics. No additional third party tools needed. Use and share Dashboards as dynamic web pages, or export reports as PDFs to easily deliver the right information, instantly. A I i r s W I a u a a c Making it Simple to Get the Job Done Right AssurX leads the industry in ease and adaptability because we re committed to customer-driven improvement. The AssurX platform is built to easily adapt to meet your evolving business needs. At every turn we re delivering powerful functionality focused on performance and flexibility, and designed with user friendliness in mind. DASHBOARD STYLE HOMEPAGES & INTUITIVE FORMS make the system easy to understand and use. Tasks, status reports, data and functionality are instantly accessible to just the right users. FULLY CONFIGURABLE GRAPHICAL USER INTERFACE (GUI) Display what you want, the way you want it using point-and-click tools. Even use your own styles and corporate colors. ADVANCED FULL TEXT SEARCH & EFFECTIVE, DETAILED QUERY tools with the unique ability to query all fields as named and configured across all forms. POINT-AND-CLICK ADMINISTRATION for easy modification of form design, approvals, workflows, escalation rules, and more. Eliminates the need for re-validation as the system is enhanced. Compliant and Secure, You Can Rest Assured Built for Compliance Particularly well suited for highly regulated industries, all AssurX solutions are designed at their core to ensure compliance. Electronic Signatures Once added to a specific record, signatures cannot be modified, copied, transferred, or deleted. Signatures can be of various types (approval, acknowledgement, etc.) and comments may be included with each. Record Archiving (Audit Trail) The only system with fully integrated records management for compliance with corporate and/or regulatory record retention policies. AssurX automatically maintains a secure, time-stamped compliant audit trail of all changes made to any electronic record. Security Controls With tight, built-in security controls from suspicious activity alerts to field/record access restrictions AssurX enables the administrator to define a wide number of parameters to ensure strong passwords and a secure system. SOPHISTICATED ACCESS RESTRICTIONS including both record and field level can be based on groups, departments, personalities and/or individuals.

AssurX Plays Well With Others Information systems are rarely afforded the luxury of operating in isolation. AssurX provides an open integration interface that delivers robust, flexible interaction with any of your existing information systems and databases. WORKS WITH ANY REPORTING TOOLS: SAP Crystal, Business Objects, Cognos, Qlik, etc. INTEGRATES WITH ANY EXTERNAL SYSTEM: ERP, MES, SCM, internally developed applications, databases, etc. With AssurX Technology, One Simple System Fits All Its true zero client web-based architecture means AssurX runs on all browsers and operating systems with no requirement to install, upgrade or manage client computers. Each fully configurable application is designed to integrate seamlessly to provide a single, all-in-one, easy to administer solution for managing quality and compliance operations enterprise-wide. HIGHLY RELIABLE using advanced, field proven technology. True zero client, 100% web-based solution including both user and administrative controls. PROVEN SCALABLE to hundreds or thousands of users, independent of client browser version or client operating system. Flexible and all-inclusive handling of unlimited number of processes without additional modules. FASTEST RESPONSE TIMES and smallest bandwidth consumption, since only pure HTML is delivered to client computers. COST-EFFECTIVE EXTENSIBILITY with open architecture lets you do advanced custom configurations (event hooks, connectivity to other databases) that don t change core code so upgrades are seamless. AssurX is easy to understand and use. Manage ANY Quality or Compliance Related Operations: CAPAs Audits & Findings Risk Management Customer Complaints RMAs Manufacturing Defects 21 CFR Part 11 Compliance Supplier Quality Change Control Commitment Tracking Safety Issues Document Control Training / Qualifications Exception Reports ISO Certification Equipment Management Gauge & Calibration Tracking Nonconformances Take advantage of AssurX s powerfully flexible solutions today. To learn how AssurX can help meet your business challenges, call us at 1-888-9-ASSURX. Production Quality Control Safety Incident Reporting Regulation & Standards Compliance