An audit is a systematic examination used to determine to what extent an object meets previously specified requirements. It is usually performed using a predefined questionnaire. Audit management enables organizations to plan and process audits, grade audit objects, monitor corrective and preventive actions that were based on the findings, and analyze audit data from different points of view.
From a business perspective, audit management provides a framework that can be applied to various application areas, such as quality management (system audits, process audits, product audits, supplier audits), environmental management, security management (site security, function security, data security), or industrial safety management.
SE Audit is a comprehensive web-based application designed to help companies manage a wide range of audit-related tasks, data, and processes.
SE Audit helps you plan and process audits, monitor corrective and preventive actions that were determined during audits, and evaluate audit data according to different criteria.
SE Audit provides the flexibility to support all types of audits, including internal audits, operational audits, IT audits, supplier audits and quality audits. It allows you to efficiently address every finding or non-conformity that is discovered during audits and enables you to be more efficient by improving the storing and tracking of information - critical for seamless organizational change.
SE Audit provides end-to-end functionality for managing the complete audit lifecycle including audit planning and scheduling, development of standard audit plans and checklists, field data collection, development of audit reports and recommendations, review of audit recommendations, and implementation of audit recommendations and remediation.
SE Audit enables companies to improve overall quality, reduce costs, and identify operational risks by facilitating the full lifecycle management of audits and helping to ensure that findings are resolved in a timely and effective manner.
The multi-lingual nature of the user interface supports you when working with foreign partners. So for each audit phase, you can specify such partners and communicate with them using the SE Audit platform.
Most importantly, SE Audit enables organizations to improve overall quality, and reduce costs and risks associated with a growing number of regulatory compliance and corporate governance processes such as those related to the ISO 9000 Quality Guidelines, ISO 13485 Medical Devices, Sarbanes-Oxley, FDA 21CFR Part 11 Electronic Record Keeping, Good Manufacturing Practices, OSHA Regulations, and others.
Audit Planning
SE Audit creates an audit packages with a well-defined objective and scope. Audit managers can organize an audit in a logical structure and hierarchy with detailed evaluation and pass/fail criteria, checklists, and tasks that need to be performed for executing the audit.
Audits can be schedule periodically or triggered on an ad-hoc basis for suppliers, internal departments or for a specific products and processes. Internal or external auditors or a team of auditors can be selected and assigned the audit responsibility with a due date.
SE Audit forwards planned audits for approval, records approved electronic signatures, notifies those who will undergo scheduled audits, and provides detailed records of audit scores for all involved parties.
Audit Execution
SE Audit enables auditors to record qualitative or quantitative findings along with detailed observations and recommendations and a checklist of questions.
A unique offline capability allows auditors to enter audit findings in notebook computers or handheld devices at remote field sites without access to the corporate network and synchronize the data with the central repository when they can access the network.
Audit managers can track the status of audits and measure the audit progress against milestones to ensure timely execution.
Audit Review
SE Audit routes audit findings and auditors recommendations to appropriate quality manager for review and subsequent actions. Findings are sent to the audited entity to seek responses on findings or issues observed.
The module has built-in workflows for reviewing responses for approval or rejection with the options to initiate internal or supplier corrective/preventive actions for undesirable variations and trends as well as to schedule follow-up audits.
Audit Reports
SE Audit provides complete visibility into the audit process through easy status tracking. It allows access to all audit data and histories as well as analysis of auditor performance and audit results. It also provides report templates and tools for building customized audit reports.
Graphical executive dashboards and flexible reports with drill-down capability provide statistics by a variety of parameters such as by audited entities, schedule, pass/fail results, CAPAs triggered, etc are included.
SE provides overall score evaluation on suppliers or individual audit process. Automatic visual alerts on any supplier who does not meet the minimum acceptable score rating.
General
Audit data is available real-time from any location through secure Internet access;
Setup your audit plan, allocating auditors and standard clauses to departments, functions or processes;
- Gives a detailed view of all the in-process audits and their status;
Allows audits to be categorized by standards (i.e. ISO 9001:2000) or by regulations (i.e. FDA GMP Part 820.22);
- Integrates with ERP systems, even in multi-company and multi-site environments;
- Establishes a consistent corporate-wide audit workflow process;
- Provides a quick visual calendar of the assigned audits for each auditor and for the entire audit team;
- Provides user-definable data fields (attributes);
- Maintains an extensive and verifiable audit trail of all activities performed in the system, which is essential for regulatory compliance;
Tracks all non-conformances, including actions and verification;
- Supports electronic signatures mandated by the FDA Title 21 CFR Part 11;
- Runs on all major operating systems and databases such as Windows, Linux, Oracle, MS SQL Server, and Firebird.
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