In today’s intense and increasingly competitive market, companies in every industry are constantly challenged. They need to deal with global suppliers, short operating margins, and strict regulations, in addition to managing both risks and the increasing pressure to accelerate time to market (TTM). There is a disconnect between how companies usually think about quality and the way they architect IT systems to support quality. The Quality Management System (QMS) is frequently still supported by stand-alone applications or even by fully manual and paper-based systems. Many quality leaders are finding their quality management system is limited in supporting efforts to achieve or sustain market leadership.
To overcome these pressures and prove their commitment, organizations are deploying integrated Enterprise Quality Management Software (EQMS). This type of solution can be applied across an enterprise, allowing quality problems to be systematically handled and providing a top-level view of quality management processes. Through centralized EQMS, quality initiatives based on ISO 9001, Lean, Kaizen, DMAIC, cGMP, Six Sigma and 8D can be implemented to stave off quality issues associated with production processes and procedures. Enterprise Quality Management software assists organizations in overcoming these obstacles and achieving operational excellence, increasing productivity levels and resulting in a true competitive advantage.
The Solution – SoftExpert EQM
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.
Enterprise Quality Management – EQM
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.
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.
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.
- 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.
- 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.
13 Processes Every Enterprise Quality Management Software (EQMS) Should Automate
Corrective Action or Preventative Action – The new risk based methodology for ISO 9001:2015