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		Achieve Real Continuous Improvement with Productivity

A nonconformance is any observed deviation or a non-fulfillment of an established requirement. It could be a product, process, or system requirement. For instance, a product out of specification, a procedure not being followed or a customer requirement not being implemented.

ISO, GMP, and other quality standards present strict guidelines that require companies to follow procedures and establish controls surrounding the nonconformance, root cause analysis, and corrective and preventive action processes.

ISOSYSTEM Action gives you one standard location to see all of your non-conformances. Everything from customer complaints to internal audit findings, supplier issues to warranty returns, ISOSYSTEM Action organizes your problems and helps you set corrective actions.

Through its comprehensive workflow management and flexible functional capabilities, ISOSYSTEM Action enables you to improve your quality system and achieve sustained regulatory compliance.

ISOSYSTEM Action incorporates organizational, classification and search tools to provide users easy and instant access to existing nonconformance records. The search results may also be viewed on spreadsheets and comparative charts.

For a complete automated handling of non-conformance and corrective/preventive actions, two worldwide renown methods are used: PDCA (Plan, Do, Check, Act) for problem solving, and 5W2H (What, When, Why, Where, Who, How, How much) for action planning. Therefore, all process steps are electronically handled, reducing your paperwork and saving time.

The integration of the ISOSYSTEM Action with the data environment of ISOSYSTEM provides access to a vast array of information from other areas.

ISOSYSTEM Action management complies with relevant international standards like ISO 9000 series.

• Initiate CAPAs from any department within your organization.
• Any number of corrective actions may be raised against a nonconformity.
• Pre-defined workflows can be used to route the problem to the appropriate department or person for proper investigation.
• Accelerate nonconformance review and approval cycles as incidents automatically move from one stage to the next.
• A nonconformance can be reported at anytime, including those detected during receiving Inspection.
• Files and any documents can be attached to CAPA workflows to provide evidence of the problem.
• Improve communication and teamwork on quality issues across departments and functional areas.
• Ensure an effective and closed-loop CAPA process by relating problem analysis and root cause to CAPA planning, implementation, and verification, as well as to effectiveness measurement.
• Eliminate the potential of lost information by electronically and securely managing all information in a centralized, scalable, and reliable system.
• Powerful root cause analysis capabilities enable you to eliminate problems at their source.
• Improve efficiency and reduce record closure time by automating your workflow and implementing fully electronic review and approval processes.
• Electronic routing and escalation capabilities enable you to streamline the entire CAPA lifecycle to ensure rapid time-to-resolution.
• Reporting capabilities provide management with real-time visibility and increase organizational control.
• Integrate with the Document, Audit, and Training Modules to create a “Closed Loop” Quality Management Solution.
• Meet 21 CFR Part 11 requirements with a signature manifestation that includes name, date, time, and meaning of electronic signature (review, approval, rejection, etc).

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