AUDIT DEFENSE READINESS
Audit management is becoming increasingly challenging, given the growing complexity of businesses and the number and types of audits that need to be conducted. For almost all industries, including highly regulated companies, periodic audits are necessary to comply with regulations and to ensure product safety, quality and customer satisfaction. Companies are therefore, fast realizing that point solutions, manual spreadsheet-based systems or antiquated systems that have not kept up with the current consumer business or technology requirements, no longer help manage internal audit programs.
CQ-Audit allows for audits to be planned and scheduled in advance. Audit plans can be defined by site, department, suppliers, etc. The audit plan can be reviewed, approved and communicated to the relevant auditors who can then plan their audit calendars accordingly. CQ-Audit will automatically notify the auditor and the auditees when the audits are due to be conducted, giving all parties time to prepare and make the audit exercise fruitful.
CQ-Audit allows for auditors to be notified of upcoming audits. The notification time period is configurable based on the company policy. Auditor can then review the past audits, open findings, critical findings, CAPAs – if any, weaknesses, new regulations to check on, etc. Audit history can be downloaded to the auditor’s mobile device including iPads to support audits to be conducted on-the-go. Auditor can also use existing best practice checklists or create and attach a custom check list document that will support the audit.
CQ-Audit supports taking notes, documentation of findings, categorization of the relevant findings, etc. on-the-go. If the auditor wishes to take summary notes and expand later when they have time to write a detailed report, the CQ-Audit solution will support the work process.
CQ-Audit enables auditors to document any number of findings and categorize them accordingly. Findings can be flagged for follow-up, requiring a response from the auditee or even marked to require a CAPA.
CQ-Audit allows for the auditors to generate audit reports based on the information entered into the solution. The audit template is based on the company template. Once the audit report is generated, the auditor may further fine tune the content of the report for language, formatting, inclusion of relevant evidence, etc. Final audit report can be routed for approvals and then issued to the auditee.
CQ-Audit has risk assessment capabilities throughout the audit process. The risk profile of an audit is initially captured during the audit planning phase. The auditor further ensures that the risk is reviewed as per audit findings. The responses are then assessed and any CAPA actions taken are reviewed for risk mitigation.
CQ-Audit allows for findings to be categorized. Through this process, the findings that reach the critical threshold by policy can be required to have a CAPA. In such a state, the solution will allow the auditor to define the need for a CAPA plan and permit the auditee to submit the appropriate corrective and preventive plans. In addition, with the integration to CQ-CAPA system critical findings may also be grouped and addressed as a systemic CAPA.
CQ-Audit provides for a portal environment that consolidates all quality data made available by the company for the supplier to interact with including the audit findings. If the auditee happens to be a supplier, they not only receive the audit report but also provide a portal environment for the suppliers to respond to the audit findings.
CQ-Audit automatically generates e-mail messages to the auditee, informing them of findings that require their attention. Auditee can login, review, document and provide the relevant responses including the actions to be taken, investigation results, etc. as part of the response.
Reach out to others across the enterprise and in the supply chain to solicit feedback without having to give up on the ownership of the tasks.
Access your EQMS solution on the go- anywhere, anytime and on any device. Complete access to the solution including reports, approvals, record views, reviews, alerts etc. ensures business continuity and improves efficiency, visibility and flexibility.
Utilize pre-developed best practices based reports. Create any number of additional reports and dashboards to suit your requirement. Information is easily retrievable, helping you make quick decisions.
Like and follow relevant records in the system. Choose to be notified via email, dashboard, and mobile to stay abreast of developments.
Managing Quality Beyond the Organization
The CQ Audit Management Solution (CQ-Audit) is a comprehensive solution that enables companies to adopt an electronic and automated approach to audit management across the enterprise. This solution provides the flexibility to support all types of audits, including internal, operational, systems, IT, supplier and quality audits. CQ-Audit helps a company manage the entire audit life cycle including audit planning and scheduling, definition of standard audit plans and checklists, aiding in conducting the audit, developing and issuing audit reports including identification and categorization of the various findings, associated risk profiles and the generation of necessary tasks for the auditees to respond to the findings including escalations to CAPAs, if deemed necessary.
AUDIT Management Overview
AUDIT Management Screenshots