Quality Management

During audits, the organizations are required to demonstrate that their adopted methods contribute to better outcomes. Hence, a proper QMS becomes very important as it reflects the organizational structure, culture, and the workflow. A proper QMS in place helps an organization to achieve its goals and objectives as it provides consistency in all the activities of the organization, from beginning till the end.
 
Laurus Infosystems, has been serving the Pharma industry for 15 years and has an excellent quality track record of having quality management systems. GMP, PICs and 21CFR Part 11 guidelines required for the compliance of the US FDA and EU EMA requirements for softwares used in the Drug Development industry are followed with strict adherence. Our quality processes are audited and certified by Top pharmaceutical companies every year for process compliance.
 
Laurus Infosystems believes that quality is an integral part of all its Development, Maintenance and Support services. Therefore, all the activities are governed by a well-documented Quality Management System. These documented processes are controlled and effectively implemented to ensure that our services meet your requirements.

Conducting third party process audit

Process-based Internal Auditing is now generally recognized as an Engine that keeps the management systems up to date and relevant to the business of the organization - particularly now that continual improvement is a requirement.Auditing is probably the one single factor that has differentiated the Quality Management Systems Standard ISO 9001 from others and has caused the Standard to become recognized globally as a primary requirement for any progressive organization. Laurus Infosystems has a team of IRCA (International Register of Certificated Auditors)qualified auditors, which will help your organization in the following ways:

  • Conducting the training on IQA(Internal Quality Assurance) and set up the team of internal auditors
  • Conduct the process audits and identify the core area for improvement.

The Quality Management System is based on SW/IPPD CMMI (CMMI for Systems Engineering/Software Engineering/Integrated Product and Process Development/Supplier Sourcing, Version 1.2) to:

  • Ensure that quality requirements are consistently met in a timely and cost-effective manner.
  • To take proactive action to avoid problems rather than taking reactive actions.This is accomplished by adopting good practices from defined processes.