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.
AssurX, Inc. • 18525 Sutter Boulevard, Suite 150 • Morgan Hill, CA 95037
Tel 888.927.7879 • Fax 408.776.1267 • info@assurx.com • www.assurx.com
© Copyright 2014, AssurX, Inc. All rights reserved.
AssurX Makes Quality & Compliance
a Given—Not Just a Goal WHY ASSURX Manage ANY Quality or
AssurX is a uniquely configurable and adaptable software system. It Management Dashboards, KPIs and Metrics AssurX Plays Well With Others Compliance Related Operations:
TRACK. MANAGE. AUTOMATE. IMPROVE. easily adjusts to fit any established or changing process, requirement Globally monitor key performance indicators and drill down to the Information systems are rarely afforded the luxury of operating in
or business. Mapping precisely to your real-world operations, the underlying data—in real time, all the time—to improve operations, isolation. AssurX provides an open integration interface that delivers CAPAs
AssurX’s powerfully flexible software unites and coordinates information, activities and documentation in one reliable system, software creates an electronic workflow of tasks, alerts, escalations governance, risk exposure and the bottom line. Identify recurring robust, flexible interaction with any of your existing information
effectively managing any quality- or compliance-related operations. The easiest on the market to deploy, configure, use and and approvals that can be automated to the level you prefer. problems and track trends, cycle times, costing and risk for the entire systems and databases.
adapt, AssurX is ideal for every business—of any size—even the most highly regulated. enterprise, by site, product, or any other parameter. Audits & Findings
It is available as either traditional OnPremise (licensed software) or • WORKS WITH ANY REPORTING TOOLS: SAP Crystal, Business
OnDemand (SaaS). • BUILT-IN REPORTS DASHBOARDS, dashboard templates and Objects, Cognos, Qlik, etc.
The software links and organizes quality and compliance data and metrics. No additional third party tools needed. Risk Management
history with schedules; tasks and activities; and compliance Easy In, Easy Up-and-running • INTEGRATES WITH ANY EXTERNAL SYSTEM: ERP, MES, SCM,
requirements and evidence across an organization. AssurX software is incredibly quick and simple to setup and deploy. • Use and share Dashboards as dynamic web pages, or export internally developed applications, databases, etc.
Ready to use processes such as corrective actions, complaint reports as PDFs to easily deliver the right information, instantly. Customer Complaints
It automatically tracks and communicates about
handling, regulatory reporting, issue tracking, audits, document
activities—sharing the right information with management, and supplier quality are provided with full With AssurX Technology, One Simple System Fits All
RMAs
the right people at the right time—and documentation, validation scripts, template forms, management Its true zero client web-based architecture means AssurX runs on
coordinates efforts between groups. dashboards, and everything else needed for fast deployment. all browsers and operating systems with no requirement to install,
upgrade or manage client computers. Each fully configurable Manufacturing Defects
Using AssurX, you’re always in • NO CLIENT SIDE SOFTWARE OR VALIDATION with a fast, application is designed to integrate seamlessly to provide a single,
easy server installation. all-in-one, easy to administer solution for managing quality and
control of activities and data; compliance operations enterprise-wide. 21 CFR Part 11 Compliance
you know immediately when • INCLUDES READY TO USE WORKFLOWS & FORMS
issues that could impact quality • HIGHLY RELIABLE using advanced,
• RAPID CUSTOM DEPLOYMENT WITH EASY POINT-AND-CLICK field proven technology. True Supplier Quality
or compliance arise; and the CONFIGURATION of workflows, forms, rules, lists, approvals, etc. zero client, 100% web-based
appropriate staff shares the No programming required. solution including both user and
information needed to quickly administrative controls. Change Control
• MINIMAL TRAINING NEEDED FOR USERS through a
evaluate and resolve problems. clean, intuitive interface and robust help and tutorials. • PROVEN SCALABLE to hundreds or
thousands of users, independent Commitment Tracking
Powerful trending and analytical • ONDEMAND OPTION lets you Manage your Business, of client browser version or client
tools allow companies to identify Not your Software.™ And, it gives the flexible option of bringing operating system. Flexible and
the system in-house at anytime. all-inclusive handling of unlimited
Safety Issues
and remediate risk exposure, avoid
number of processes without
quality or noncompliance problems, and
additional modules. Document Control
improve operations. Making it Simple to Get the Job Done Right
AssurX leads the industry in ease and adaptability because we’re
Compliant and Secure, You Can Rest Assured • FASTEST RESPONSE TIMES
With decades of expertise built into their committed to customer-driven improvement. The AssurX platform is Built for Compliance and smallest bandwidth Training / Qualifications
solutions, AssurX helps companies exceed built to easily adapt to meet your evolving business needs. At every Particularly well suited for highly regulated industries, all AssurX consumption, since only pure
turn we’re delivering powerful functionality focused on performance solutions are designed at their core to ensure compliance. HTML is delivered to client
quality expectations, ensure compliance, manage Providing clear views of
and flexibility, and designed with user friendliness in mind. computers.
risks and better govern their enterprise. coordinated activities and information Exception Reports
• Electronic Signatures Once added to a specific record,
across all areas of a business, AssurX delivers • DASHBOARD STYLE HOMEPAGES & INTUITIVE FORMS make the signatures cannot be modified, copied, transferred, or deleted. • COST-EFFECTIVE EXTENSIBILITY
the power to easily orchestrate operations; system easy to understand and use. Tasks, status reports, data with open architecture lets
Signatures can be of various types (approval, acknowledgement, ISO Certification
detect, correct and prevent problems; and and functionality are instantly accessible to just the right users. etc.) and comments may be included with each. you do advanced custom
configurations (event
improve quality, compliance and your bottom line. • FULLY CONFIGURABLE GRAPHICAL USER INTERFACE (GUI) • Record Archiving (Audit Trail) The only system with fully hooks, connectivity to other
Display what you want, the way you want it using point-and-click Equipment Management
integrated records management for compliance with corporate databases) that don’t change
tools. Even use your own styles and corporate colors. and/or regulatory record retention policies. AssurX automatically core code—so upgrades
maintains a secure, time-stamped compliant audit trail of all are seamless. Gauge & Calibration Tracking
• ADVANCED FULL TEXT SEARCH & EFFECTIVE, DETAILED QUERY
Whatever You Make, AssurX Makes it Easier for You tools with the unique ability to query all fields as named and
changes made to any electronic record.

Especially well suited for complex operations, distributed, and rapidly growing or changing businesses, AssurX excels in every industry. configured across all forms. AssurX is easy to understand and use. Nonconformances
Solutions are preconfigured to work within each industry’s best practices and regulations, and perform in a range of markets including: Security Controls
• POINT-AND-CLICK ADMINISTRATION for easy modification of With tight, built-in security controls—from suspicious activity alerts
form design, approvals, workflows, escalation rules, and more. to field/record access restrictions—AssurX enables the administrator Production Quality Control
• energy & utilities • pharmaceutical • medical device Eliminates the need for re-validation as the system is enhanced. to define a wide number of parameters to ensure strong passwords
and a secure system.
Take advantage of AssurX’s
• biotechnology • contract manufacturing • consumer goods powerfully flexible solutions today. Safety Incident Reporting
• food & beverage • finance • aerospace • SOPHISTICATED ACCESS RESTRICTIONS including both record and To learn how AssurX can help meet your
field level can be based on groups, departments, personalities business challenges,
• semiconductor • insurance • high technology and/or individuals. call us at 1-888-9-ASSURX. Regulation & Standards Compliance
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.
AssurX, Inc. • 18525 Sutter Boulevard, Suite 150 • Morgan Hill, CA 95037
Tel 888.927.7879 • Fax 408.776.1267 • info@assurx.com • www.assurx.com
© Copyright 2014, AssurX, Inc. All rights reserved.
AssurX Makes Quality & Compliance
a Given—Not Just a Goal WHY ASSURX Manage ANY Quality or
AssurX is a uniquely configurable and adaptable software system. It Management Dashboards, KPIs and Metrics AssurX Plays Well With Others Compliance Related Operations:
TRACK. MANAGE. AUTOMATE. IMPROVE. easily adjusts to fit any established or changing process, requirement Globally monitor key performance indicators and drill down to the Information systems are rarely afforded the luxury of operating in
or business. Mapping precisely to your real-world operations, the underlying data—in real time, all the time—to improve operations, isolation. AssurX provides an open integration interface that delivers CAPAs
AssurX’s powerfully flexible software unites and coordinates information, activities and documentation in one reliable system, software creates an electronic workflow of tasks, alerts, escalations governance, risk exposure and the bottom line. Identify recurring robust, flexible interaction with any of your existing information
effectively managing any quality- or compliance-related operations. The easiest on the market to deploy, configure, use and and approvals that can be automated to the level you prefer. problems and track trends, cycle times, costing and risk for the entire systems and databases.
adapt, AssurX is ideal for every business—of any size—even the most highly regulated. enterprise, by site, product, or any other parameter. Audits & Findings
It is available as either traditional OnPremise (licensed software) or • WORKS WITH ANY REPORTING TOOLS: SAP Crystal, Business
OnDemand (SaaS). • BUILT-IN REPORTS DASHBOARDS, dashboard templates and Objects, Cognos, Qlik, etc.
The software links and organizes quality and compliance data and metrics. No additional third party tools needed. Risk Management
history with schedules; tasks and activities; and compliance Easy In, Easy Up-and-running • INTEGRATES WITH ANY EXTERNAL SYSTEM: ERP, MES, SCM,
requirements and evidence across an organization. AssurX software is incredibly quick and simple to setup and deploy. • Use and share Dashboards as dynamic web pages, or export internally developed applications, databases, etc.
Ready to use processes such as corrective actions, complaint reports as PDFs to easily deliver the right information, instantly. Customer Complaints
It automatically tracks and communicates about
handling, regulatory reporting, issue tracking, audits, document
activities—sharing the right information with management, and supplier quality are provided with full With AssurX Technology, One Simple System Fits All
RMAs
the right people at the right time—and documentation, validation scripts, template forms, management Its true zero client web-based architecture means AssurX runs on
coordinates efforts between groups. dashboards, and everything else needed for fast deployment. all browsers and operating systems with no requirement to install,
upgrade or manage client computers. Each fully configurable Manufacturing Defects
Using AssurX, you’re always in • NO CLIENT SIDE SOFTWARE OR VALIDATION with a fast, application is designed to integrate seamlessly to provide a single,
easy server installation. all-in-one, easy to administer solution for managing quality and
control of activities and data; compliance operations enterprise-wide. 21 CFR Part 11 Compliance
you know immediately when • INCLUDES READY TO USE WORKFLOWS & FORMS
issues that could impact quality • HIGHLY RELIABLE using advanced,
• RAPID CUSTOM DEPLOYMENT WITH EASY POINT-AND-CLICK field proven technology. True Supplier Quality
or compliance arise; and the CONFIGURATION of workflows, forms, rules, lists, approvals, etc. zero client, 100% web-based
appropriate staff shares the No programming required. solution including both user and
information needed to quickly administrative controls. Change Control
• MINIMAL TRAINING NEEDED FOR USERS through a
evaluate and resolve problems. clean, intuitive interface and robust help and tutorials. • PROVEN SCALABLE to hundreds or
thousands of users, independent Commitment Tracking
Powerful trending and analytical • ONDEMAND OPTION lets you Manage your Business, of client browser version or client
tools allow companies to identify Not your Software.™ And, it gives the flexible option of bringing operating system. Flexible and
the system in-house at anytime. all-inclusive handling of unlimited
Safety Issues
and remediate risk exposure, avoid
number of processes without
quality or noncompliance problems, and
additional modules. Document Control
improve operations. Making it Simple to Get the Job Done Right
AssurX leads the industry in ease and adaptability because we’re
Compliant and Secure, You Can Rest Assured • FASTEST RESPONSE TIMES
With decades of expertise built into their committed to customer-driven improvement. The AssurX platform is Built for Compliance and smallest bandwidth Training / Qualifications
solutions, AssurX helps companies exceed built to easily adapt to meet your evolving business needs. At every Particularly well suited for highly regulated industries, all AssurX consumption, since only pure
turn we’re delivering powerful functionality focused on performance solutions are designed at their core to ensure compliance. HTML is delivered to client
quality expectations, ensure compliance, manage Providing clear views of
and flexibility, and designed with user friendliness in mind. computers.
risks and better govern their enterprise. coordinated activities and information Exception Reports
• Electronic Signatures Once added to a specific record,
across all areas of a business, AssurX delivers • DASHBOARD STYLE HOMEPAGES & INTUITIVE FORMS make the signatures cannot be modified, copied, transferred, or deleted. • COST-EFFECTIVE EXTENSIBILITY
the power to easily orchestrate operations; system easy to understand and use. Tasks, status reports, data with open architecture lets
Signatures can be of various types (approval, acknowledgement, ISO Certification
detect, correct and prevent problems; and and functionality are instantly accessible to just the right users. etc.) and comments may be included with each. you do advanced custom
configurations (event
improve quality, compliance and your bottom line. • FULLY CONFIGURABLE GRAPHICAL USER INTERFACE (GUI) • Record Archiving (Audit Trail) The only system with fully hooks, connectivity to other
Display what you want, the way you want it using point-and-click Equipment Management
integrated records management for compliance with corporate databases) that don’t change
tools. Even use your own styles and corporate colors. and/or regulatory record retention policies. AssurX automatically core code—so upgrades
maintains a secure, time-stamped compliant audit trail of all are seamless. Gauge & Calibration Tracking
• ADVANCED FULL TEXT SEARCH & EFFECTIVE, DETAILED QUERY
Whatever You Make, AssurX Makes it Easier for You tools with the unique ability to query all fields as named and
changes made to any electronic record.

Especially well suited for complex operations, distributed, and rapidly growing or changing businesses, AssurX excels in every industry. configured across all forms. AssurX is easy to understand and use. Nonconformances
Solutions are preconfigured to work within each industry’s best practices and regulations, and perform in a range of markets including: Security Controls
• POINT-AND-CLICK ADMINISTRATION for easy modification of With tight, built-in security controls—from suspicious activity alerts
form design, approvals, workflows, escalation rules, and more. to field/record access restrictions—AssurX enables the administrator Production Quality Control
• energy & utilities • pharmaceutical • medical device Eliminates the need for re-validation as the system is enhanced. to define a wide number of parameters to ensure strong passwords
and a secure system.
Take advantage of AssurX’s
• biotechnology • contract manufacturing • consumer goods powerfully flexible solutions today. Safety Incident Reporting
• food & beverage • finance • aerospace • SOPHISTICATED ACCESS RESTRICTIONS including both record and To learn how AssurX can help meet your
field level can be based on groups, departments, personalities business challenges,
• semiconductor • insurance • high technology and/or individuals. call us at 1-888-9-ASSURX. Regulation & Standards Compliance
AssurX Makes Quality & Compliance
a Given—Not Just a Goal WHY ASSURX Manage ANY Quality or
AssurX is a uniquely configurable and adaptable software system. It Management Dashboards, KPIs and Metrics AssurX Plays Well With Others Compliance Related Operations:
TRACK. MANAGE. AUTOMATE. IMPROVE. easily adjusts to fit any established or changing process, requirement Globally monitor key performance indicators and drill down to the Information systems are rarely afforded the luxury of operating in
or business. Mapping precisely to your real-world operations, the underlying data—in real time, all the time—to improve operations, isolation. AssurX provides an open integration interface that delivers CAPAs
AssurX’s powerfully flexible software unites and coordinates information, activities and documentation in one reliable system, software creates an electronic workflow of tasks, alerts, escalations governance, risk exposure and the bottom line. Identify recurring robust, flexible interaction with any of your existing information
effectively managing any quality- or compliance-related operations. The easiest on the market to deploy, configure, use and and approvals that can be automated to the level you prefer. problems and track trends, cycle times, costing and risk for the entire systems and databases.
adapt, AssurX is ideal for every business—of any size—even the most highly regulated. enterprise, by site, product, or any other parameter. Audits & Findings
It is available as either traditional OnPremise (licensed software) or • WORKS WITH ANY REPORTING TOOLS: SAP Crystal, Business
OnDemand (SaaS). • BUILT-IN REPORTS DASHBOARDS, dashboard templates and Objects, Cognos, Qlik, etc.
The software links and organizes quality and compliance data and metrics. No additional third party tools needed. Risk Management
history with schedules; tasks and activities; and compliance Easy In, Easy Up-and-running • INTEGRATES WITH ANY EXTERNAL SYSTEM: ERP, MES, SCM,
requirements and evidence across an organization. AssurX software is incredibly quick and simple to setup and deploy. • Use and share Dashboards as dynamic web pages, or export internally developed applications, databases, etc.
Ready to use processes such as corrective actions, complaint reports as PDFs to easily deliver the right information, instantly. Customer Complaints
It automatically tracks and communicates about
handling, regulatory reporting, issue tracking, audits, document
activities—sharing the right information with management, and supplier quality are provided with full With AssurX Technology, One Simple System Fits All
RMAs
the right people at the right time—and documentation, validation scripts, template forms, management Its true zero client web-based architecture means AssurX runs on
coordinates efforts between groups. dashboards, and everything else needed for fast deployment. all browsers and operating systems with no requirement to install,
upgrade or manage client computers. Each fully configurable Manufacturing Defects
Using AssurX, you’re always in • NO CLIENT SIDE SOFTWARE OR VALIDATION with a fast, application is designed to integrate seamlessly to provide a single,
easy server installation. all-in-one, easy to administer solution for managing quality and
control of activities and data; compliance operations enterprise-wide. 21 CFR Part 11 Compliance
you know immediately when • INCLUDES READY TO USE WORKFLOWS & FORMS
issues that could impact quality • HIGHLY RELIABLE using advanced,
• RAPID CUSTOM DEPLOYMENT WITH EASY POINT-AND-CLICK field proven technology. True Supplier Quality
or compliance arise; and the CONFIGURATION of workflows, forms, rules, lists, approvals, etc. zero client, 100% web-based
appropriate staff shares the No programming required. solution including both user and
information needed to quickly administrative controls. Change Control
• MINIMAL TRAINING NEEDED FOR USERS through a
evaluate and resolve problems. clean, intuitive interface and robust help and tutorials. • PROVEN SCALABLE to hundreds or
thousands of users, independent Commitment Tracking
Powerful trending and analytical • ONDEMAND OPTION lets you Manage your Business, of client browser version or client
tools allow companies to identify Not your Software.™ And, it gives the flexible option of bringing operating system. Flexible and
the system in-house at anytime. all-inclusive handling of unlimited
Safety Issues
and remediate risk exposure, avoid
number of processes without
quality or noncompliance problems, and
additional modules. Document Control
improve operations. Making it Simple to Get the Job Done Right
AssurX leads the industry in ease and adaptability because we’re
Compliant and Secure, You Can Rest Assured • FASTEST RESPONSE TIMES
With decades of expertise built into their committed to customer-driven improvement. The AssurX platform is Built for Compliance and smallest bandwidth Training / Qualifications
solutions, AssurX helps companies exceed built to easily adapt to meet your evolving business needs. At every Particularly well suited for highly regulated industries, all AssurX consumption, since only pure
turn we’re delivering powerful functionality focused on performance solutions are designed at their core to ensure compliance. HTML is delivered to client
quality expectations, ensure compliance, manage Providing clear views of
and flexibility, and designed with user friendliness in mind. computers.
risks and better govern their enterprise. coordinated activities and information Exception Reports
• Electronic Signatures Once added to a specific record,
across all areas of a business, AssurX delivers • DASHBOARD STYLE HOMEPAGES & INTUITIVE FORMS make the signatures cannot be modified, copied, transferred, or deleted. • COST-EFFECTIVE EXTENSIBILITY
the power to easily orchestrate operations; system easy to understand and use. Tasks, status reports, data with open architecture lets
Signatures can be of various types (approval, acknowledgement, ISO Certification
detect, correct and prevent problems; and and functionality are instantly accessible to just the right users. etc.) and comments may be included with each. you do advanced custom
configurations (event
improve quality, compliance and your bottom line. • FULLY CONFIGURABLE GRAPHICAL USER INTERFACE (GUI) • Record Archiving (Audit Trail) The only system with fully hooks, connectivity to other
Display what you want, the way you want it using point-and-click Equipment Management
integrated records management for compliance with corporate databases) that don’t change
tools. Even use your own styles and corporate colors. and/or regulatory record retention policies. AssurX automatically core code—so upgrades
maintains a secure, time-stamped compliant audit trail of all are seamless. Gauge & Calibration Tracking
• ADVANCED FULL TEXT SEARCH & EFFECTIVE, DETAILED QUERY
Whatever You Make, AssurX Makes it Easier for You tools with the unique ability to query all fields as named and
changes made to any electronic record.

Especially well suited for complex operations, distributed, and rapidly growing or changing businesses, AssurX excels in every industry. configured across all forms. AssurX is easy to understand and use. Nonconformances
Solutions are preconfigured to work within each industry’s best practices and regulations, and perform in a range of markets including: Security Controls
• POINT-AND-CLICK ADMINISTRATION for easy modification of With tight, built-in security controls—from suspicious activity alerts
form design, approvals, workflows, escalation rules, and more. to field/record access restrictions—AssurX enables the administrator Production Quality Control
• energy & utilities • pharmaceutical • medical device Eliminates the need for re-validation as the system is enhanced. to define a wide number of parameters to ensure strong passwords
and a secure system.
Take advantage of AssurX’s
• biotechnology • contract manufacturing • consumer goods powerfully flexible solutions today. Safety Incident Reporting
• food & beverage • finance • aerospace • SOPHISTICATED ACCESS RESTRICTIONS including both record and To learn how AssurX can help meet your
field level can be based on groups, departments, personalities business challenges,
• semiconductor • insurance • high technology and/or individuals. call us at 1-888-9-ASSURX. Regulation & Standards Compliance
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.
AssurX, Inc. • 18525 Sutter Boulevard, Suite 150 • Morgan Hill, CA 95037
Tel 888.927.7879 • Fax 408.776.1267 • info@assurx.com • www.assurx.com
© Copyright 2014, AssurX, Inc. All rights reserved.