Enterprise Quality Management

Modernize your QMS and increase customer satisfaction


The Challenge

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.

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.


Screenshots

Process mapping

Quality Performance Indicators

Document control

Nonconformities and deviations

Quality tools

Corrective and preventive actions (CAPA)

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.

Solution Overview