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FDA Compliance

AssurX Releases Audit Management Software Update

Manage risk while meeting regulatory requirements and compliance

Published: Monday, November 2, 2015 - 11:20

(AssurX: Morgan Hill, CA) -- AssurX, Inc., a leading enterprise quality management, risk, and regulatory compliance solution provider, has released the latest update to its AssurX audit management software.

Key benefits to the organization
The AssurX software update keeps all stages of the audit process efficient and ensures important activities and issues are being handled properly and on time. The many features help organizations manage risk while meeting regulatory requirements and compliance.

Reduce audit cycle times and increase audit consistency
With the best-practices workflow of this solution, clients reduce errors and missing records. As a result, audit cycle times are significantly reduced.

Meets regulatory requirements for multiple industries
All audit activities are systematically managed and recorded to meet requirements for regulations with validation, audit trail, electronic signatures, retention, and traceability. Companies using the audit management solution meet regulatory requirements and maintain compliance (FDA, ISO, SOX, EMEA, GXP, NERC, and more).

FDA 21 CFR Part 11-compliant
This system is 100-percent compliant with the FDA’s 21 CFR Part 11 requirement for electronic records and electronic signatures.

Types of audit supported
The AssurX system supports any audit finding: internal, external, supplier, laboratory, operational, regulatory, GXP, risk assessment, third-party, and environmental, health and safety (EH&S).

Effectively manage audit and response process at all levels of organization
No matter where a finding originates, or how many departments the issue touches, the system can effectively manage the audit and response processes from start to finish.

Critical analysis with updated analytics and reporting capabilities
With the new dynamic analytics and dashboards in this update, management is provided with real-time visibility into audit activities and metrics to make timely, global trend analysis and risk assessment.

Fully integrated with other quality management processes
The audit management system is fully integrated with other quality management processes such as corrective action management, issue tracking, change management, and document control. Every finding is effectively resolved no matter where it leads.

Time-stamped audit trail
Once added to a record, signatures cannot be modified, copied, transferred, or deleted. AssurX automatically maintains a time-stamped audit trail of all changes to any electronic record.

Automated tracking, trending, and risk assessment
Automated tracking, trending, and risk assessment is based on findings classified by properties you define.

Audit classification, follow-up, and final report
Using a best practices workflow, audits are conducted after being planned and scheduled. Findings are automatically logged and classified, and follow-up activities are assigned. Corrective actions are launched if necessary. The audit management system is efficient and ensures critical that activities and issues are properly handled with automatic task assignment, email notifications, and escalations. When all follow-up actions are processed, a comprehensive report is issued, and the audit is completed.

Electronic library created for new audits
An electronic library of reusable audit questions and processes is created that can be automatically applied to new audits.

Available on premise or on demand
The AssurX Audit Management solution is available in two software delivery options: OnPremise or OnDemand. OnPremise is licensed software. OnDemand is Software as a Service (SaaS) and provided quickly, securely, and reliably over the Internet.

To learn more, click here.

Register for AssurX audit management webinar
For access to the webinar with more detailed information about the AssurX audit management solution, click here.


About The Author

AssurX’s picture


AssurX Inc. develops quality management and regulatory compliance software solutions to help companies in any industry exceed quality expectations, ensure compliance, manage risks, and better govern their enterprise. AssurX solutions securely handle manufacturing defects, complaints, change control, regulatory compliance, supplier quality, audits, risk, corrective and preventive actions, and more.