Overview
At the core of AssurX’s Quality and Compliance Management Solutions is a Web-based, closed-loop corrective action tracking system that automates and streamlines the entire CAPA process. Issues initiated from any department are investigated, root causes identified, corrective/preventive actions planned and implemented across operations, and then evaluated for effectiveness—all in a best practices workflow.

AssurX CAPA software is designed to work for companies following Good Manufacturing Practices (GMPs) and seamlessly reaches into all business operations—even suppliers—to centrally manage quality issues and ensure compliance. Because it’s fully integrated with other quality related processes such as audits, nonconformance, customer complaints, change management, etc., no matter where an issue originates, or how many departments the problem touches, the system can effectively manage its resolution.

The CAPA solution is available as either traditional OnPremise (licensed software) or OnDemand (SaaS).

With AssurX CAPA companies can:

• Automatically capture detailed data about quality problems from anywhere in the operation
  
• Centralize/streamline/speed CAPA processing and link related incidents and information across the enterprise for a holistic approach
• Get real time trending with dashboards and analytics that deliver instant business intelligence, accessed anywhere with an Internet connection
• Reduce quality incidents and prevent recurrences
• Control costs and make better product the first time around
• Meet regulatory requirements for closed-loop quality management with electronic records and signatures, and time stamped audit trails
• Lower risk of regulatory non-compliance across operations (FDA, ISO, SOX, EMEA, NERC, HACCP, etc.)

Powerful analytics/reporting capabilities along with graphical dashboards, give managers detailed real-time visibility into the CAPA system and make global trend analysis simple.

Key Features:
Integrated Enterprise-Wide CAPA Initiation
CAPAs initiated from any source or system are automatically associated with related issues and CAPAs, creating an enterprise level approach to solving quality problems. The system assigns the investigation to an owner based on conditions such as product line, issue type, or personnel roles.

• CAPAs can be initiated from any issue source including complaint, nonconformance, finding, return, corrective action request, safety incident, supplier issue, etc.
• Automatically link CAPAs to one or more existing or new issues, or initiate independent of a logged issue. CAPAs can be associated based on any parameter (eg: product, process, issue type, cause code, etc.). Trend reports and graphs are hyperlinked directly from the related CAPA records to provide instant trend analysis.
• Manually or automatically assign CAPAs to an investigator. Automatic assignments can be based on any known condition such as product line, initiator’s department, role, etc.
• Automatically set due dates based on business rules or CAPA criticality.
• Notify affected personnel of new assignments automatically via email with a hyperlink to the initiated record.

Investigation/Root Cause Analysis
The system’s automated workflows efficiently drive root cause analysis. Investigators are automatically assigned tasks with hyperlinks to associated CAPA record(s). Based on preset rules, task owners are sent reminders for pending due dates and notices of escalation, reassignment or approvals. CAPAs that have been linked/associated are delivered with instant trend analysis via hyperlinks to trend reports and graphs.

• Break investigation into smaller tasks and distribute those tasks to a group of users. Assign tasks to document progress and results, attach files, add notes and forward questions by email.
• Classify and track defined trend elements including problem types, products, root cause codes, cost codes, etc.
• Auto-update affected personnel’s task list in real time to reflect new or changed assignments and send email notification.
• Supervisors/process owners are automatically notified of task milestone and approval accomplishments.

Auto-Escalation, Notification, Reminders
A system of automatic escalation, notices and reminders that can be flexibly defined keeps the process moving, and prevents issues and tasks from falling through the cracks.

• Define automatic reminders and escalation rules by process
• Automatically escalate tasks to supervisor or CAPA owner if tasks not completed by due date based on pre-defined rules.
• Define escalation rule notification lists, conditions and authoring of email subject and body.
• Notices and reminders include hyperlinks to any associated record, report or trend chart.

Action Planning
CAPA owners use the system to draft action plans based on root cause analysis and assign responsibility to implement the plan to other users. The solution routes cause analysis with proposed action plan details for review/evaluation using a best practice workflow.

• Automatically or manually select best practice workflows (included with the system) with predefined steps, assignees, due date intervals, sequence and routing to create a plan. Or, build your own using simple tools that require no programming.
• Easily modify plans by adding detail to the process steps (task detail, due date increment, assignee, etc.), or adding/removing process steps using simple point-and-click tools.
• Automatically set due dates for any task, including approval requests based on intervals defined in the plan. Personnel are automatically emailed reminders of approaching due dates and when tasks are past due.
• Save draft plans prior to routing.
• Dispatch plans for approval via serial or parallel routing and automatically notify approvers via email and in their home page task list.
• Notify CAPA owners automatically when a plan is approved and initiate the first plan step when final signature is obtained.

Implementation & Project Tracking
The system’s automated workflows efficiently drive the CAPA implementation and track tasks, due dates and milestones with automatic escalation and notification when targets are missed.

• Implementation tasks are automatically assigned to task owners based on approved plan with notice of assignment and an update to their home page task list.
• The system sets and monitors task due dates based on the plan and notifies owners of approaching and past due dates. Auto-escalation is triggered if tasks are not completed on time.
• Very late tasks can be automatically reassigned based on predefined rules
• Notification is sent to CAPA owner when team tasks are completed with an option to automatically close the case when all tasks are completed.

Effectiveness Verification
Automatic follow up to confirm effectiveness of the action plan can be built into the process; the result of the verification is routed back to the appropriate managers for approval and final closure of the CAPA project.

• Effectiveness verification plans can be documented prior to implementing correction action. The verification audit date is set automatically based on business rules and supporting rationale documentation is included as file attachments.
• CAPA projects can be automatically closed on approval/closure of the effectiveness verification. Or, a new CAPA project (linked to original) can be initiated if the corrective action is found to not be effective.

Powerful CAPA Oversight
Real time Performance Reporting, Monitoring and Management Visibility
The system comes with built-in dashboards, metrics and ad-hoc query functionality for real time reporting, trending and analysis. The simple to use dashboards make detailed analysis and effective decisions easy, and provide the unique ability to query all fields as named and configured across all forms and integrated processes.

• Built-in management dashboards are simple for users to set up and personalize with point-and-click tools.
• Monitor real time performance for the entire enterprise or by division, functional area, department or other group.
• Automatically generate management reports on:
  • Trend elements like products, problem type, root cause codes, cost codes, etc. by department, function, division, corporation and more
  • Cycle times for CAPA activities such as response, resolution, planning, implementation times, etc., that trend by month, quarter, year
  • Costs for activities, including labor and material costs tending by month, quarter, year
• Drill down capabilities for all reports—even navigate to individual records.

100% Compliant: Audit Trail, Electronic Signatures
The system is compliant to 21 CFR Part 11. 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. AssurX automatically maintains a secure, time-stamped compliant record archive (audit trail) of all changes made to any electronic record. Records and changes are displayed together in their entirety.

Fast and Easy Deployment
Because of its flexible, intuitive design, AssurX CAPA is quick and simple to configure and deploy. The turnkey CAPA management processes are provided with documentation, setup and use guides, validation scripts, template forms and workflows, executive dashboards, and everything else needed for quick deployment.

• Simple point-and-click configuration of workflows, fields, forms, rules, lists, signatures, etc. No programming required.
• No client side software/validation with a fast, easy server installation.
• Minimal training needed for users due to a clean, intuitive interface with robust help files.
• OnDemand (Software-as-a-Service) option gets you up and running in days with no hardware or software to install and no waiting for IT staff. OnDemand also gives the flexible option of bringing the system “in-house” at anytime.

Making It Simple To Get The Job Done Right
AssurX leads the industry in ease of use by delivering powerful flexibility and functionality focused not only on performance, but designed with user friendliness in mind

• Includes out-of-the-box, ready to use CAPA forms and best practice workflows you can easily modify. Or, build your own using simple configuration tools that require NO programming.
• Point-and-click administration for form design, signature workflows, escalation rules, and more. Eliminates the need for revalidation as the system is enhanced.
• User-friendly forms for quick and accurate entry with features like auto-fill and default-entry fields, color-coded mandatory fields and plain language error/feedback messages.
• Full text search (basic to advanced). The most sophisticated on the market today.
• Simple, fully configurable Graphical Interface (GUI) and reports make AssurX CAPA easy to use. Customize the GUI with your own images, logos, styles and corporate colors.

With AssurX Technology, One Simple System Fits All
Its true zero-client architecture means AssurX runs on all browsers and operating systems with no need to install, upgrade, validate or manage client computers. Built-in, configurable processes are designed to integrate seamlessly with each other providing a single, all-in-one solution for managing quality and compliance enterprise-wide.

• Remote access with fast performance (average sub-second response times) from low bandwidth locations (dial-up, overseas, etc.)
• Provide access to business partners and key suppliers via restricted use login
• Integrate with any external system or database: ERP, MES, SCM, internally developed applications, databases, etc., using a robust, flexible open integration interface.

The AssurX CAPA solution is available as either OnDemand (SaaS) or OnPremise. Click here to request a demo today!