SoftExpert EQM: Enterprise Quality Management Software

SoftExpert EQM is the most comprehensive enterprise quality management software (EQMS). It helps companies to achieve and maintain ISO 9001 certification through automated, highly interactive quality processes tailored to an organization’s specific products, operations and business practices.

As a modular and scalable solution platform, SoftExpert Quality Management Software seamlessly integrates all key quality initiatives, including process mapping, documented information (SOP – standard operating procedures, work instructions and records), non-conformance reports (NCR/NCMR), corrective/preventive actions (CAPA), quality indicators (KPIs). The solution also manages supplier relations, customer complaints, quality audits, competence and training, quality risks and controls, quality inspection and statistical process control, increasing QMS agility and robustness.

With SoftExpert EQMS, companies can comply with multiple regulations and standards, including ISO 9001:2015, FDA, ICH, and EU. The solution easily manages, tracks and reports all quality metrics in real-time, streamlining informed decisions. It allows companies to coordinate and drive business activities, meet customer and regulatory requirements and improve their effectiveness and efficiency on a continual basis.

Through the Plan-Do-Check-Act (PDCA) cycle, SoftExpert EQM allows companies to design & build, deploy, control & measure, review and improve the QMS, ensuring continuous improvement to both the product and the QMS. The solution can proactively prevent deviations and promptly detect, identify, track, and resolve quality issues, significantly reducing compliance costs and the risk of non-compliance. It promotes collaboration and reliability to produce consistent results, preventing mistakes and ensuring customer satisfaction.

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Main Benefits

• Customer self-service – secure Web-based operations.
• Collaboration skill enhancement through real-time access to information.
• Process identification, mapping, implementation and monitoring are handled more effectively.
• The delays and inefficiency common to manual activities are eliminated.
• Efficiency and agility in planning and carrying out the activities required to maintain the QMS.
• Lower document printing costs.
• Simplify CAPA management and increase QMS productivity and efficiency.
• Accurate identification of regulatory requirements that affect management system performance.
• Efficient monitoring of opportunities for improvement, comments, nonconformities, etc.
• Optimization of financial resources invested in management programs.
• Better relationships with shareholders, customers, the community, suppliers and employees.

Features

• CENTRAL REPOSITORY

Single central repository of documented information, to streamline compliance with quality standards and regulations.

• AUDIT

Efficient auditing processes, to identify inconsistencies in quality processes.

• NCR

Intuitive electronic forms to automate non-conformance reporting (NCR), non-conforming material reporting (NCMR), customer complaints, and more.

• CAUSE ANALYSIS

Fastest cause analysis through automated Ishikawa and other quality tools.

• RISK ANALYSIS

Proactive identification and mitigation of quality risks through consistent risk analysis.

• KPIS

Friendly monitoring of quality KPIs, through personalized portals.

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Return on Investment (ROI)

From 1850 to around 1975, the sustainable competitive advantage of industrial organizations was related exclusively to the benefit of economies of scale and scope, rapid allocation of technology, fixed assets and excellence in the management of financial assets and liabilities in an economy dominated by tangible assets. This economy was based solely on financial indicators for performance management, no longer applicable today because organizations have transferred their assets to tangible assets.

For Kaplan and Norton (1997), financial measures are designed to compare previous periods based on internal standards of performance. While such measures may present this information in a fairly consistent fashion, the financial outlook is no longer able to predict the future and also prevents the first signs of relationship problems, quality and new opportunities. This is because the speed with which information technology is evolving prompts major changes that demand a larger amount of information and new skills to manage organizational processes in order to guarantee competitive advantages in terms of making operational and strategic decisions on time.

Experts call attention to the fact that, in the current scenario, the use of traditional financial measures alone is no longer appropriate, since the probability of failure is too high. This leads organizations to develop new methods and tools for supporting the measurement of overall performance, balancing not only the tangible assets, but also the intangible ones that will assist with short and long term decisions.

In this sense, SoftExpert quality management software offers a wide range of natively integrated tools (components) to fully assist all phases of management process, supporting performance management, balance between tangible and intangible assets, transparency of processes and improvement of stakeholder confidence, with the following main advantages:

• Lowered TCO through increased reliability and scalability leading to greater administrative productivity.
• Increased user productivity with the ability to communicate whenever and wherever needed with collaboration tools.
• Streamlined solution operations and reduced risk by leveraging a full range of capabilities.
• Compliance with major regulations.
• Reduced ongoing costs with flexible financing and support options.
• Allows for modular and incremental implementation, with worldwide services and support.

FINANCIAL ROI

Annual Savings

• Reduced general expenses to complete activities demanded by applicable norms.
• Elimination of delays and inefficiencies that usually occur in manual activities.
• Collaboration skill enhancement through real-time access to information.
• Reduced management system costs.
• Increased efficiency in maintenance system planning and activities.
• Optimization of financial resources invested in management programs.

Investment

• The investment in SoftExpert EQM will depend upon the business unit size and implementation approach.

Return on Investment (%)

• (((Total Annual Savings x n years) – Initial Investment) / Initial Investment) x 100.

Payback Period (years)

• Initial Investment / Total Annual Savings.

NON FINANCIAL ROI

• Consistent, reliable and standardized information.
• Accurate identification of regulatory requirements and issues affecting management system performance.
• Monitoring occurrences, such as: best practices, opportunities for improvement, comments, nonconformities, etc.
• Improved relationship with shareholders, customers, community, suppliers and employees.

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