Quality management software brings organizational focus on customer satisfaction and continuous improvement and provides the backbone for meeting ISO certification, FDA and other regulatory requirements.
Implementation is easy and highly customizable, so you are can plan, track and improve every aspect of your company’s policies and procedures.
Seven of the twenty-six modules included in The Lean Machine are focused on quality; these modules create a strong foundation on which to build a lean and mean company
Our robust document management module, one of 26 modules included in our software, will help you get control of the paper floating around your office and quickly conform to ISO 9001, 13485, FDA, or other regulatory requirements.
Integrated with our inventory management, quality, internal audit, and corrective action (CAPA) modules, you will also better manage supplier quality.
The quality of the documents you put into your document management system is as important as ensuring employees are looking at the correct revision.
Which ever way you decide to start a procedure, the Document Templates system in The Lean Machine™ will start you off on the right foot.
Deviations from the approved procedures in your document management system can potentially affect quality, and therefore, regulatory compliance. Also called out-of-specification (OOS) results, deviations can occur during raw material and finished product acceptance, sampling and testing, manufacturing, or product distribution.
While it is impossible to completely avoid deviations, FDA-regulated companies, especially pharmaceutical companies, must have the ability to manage both planned and unplanned deviations.
Corrective and preventative actions require a flexible tool that will help you determine the root cause of non-conformities or other undesirable situations and prevent their recurrence.
Identifying and controlling non-conforming material is critical to prevent unintended use or delivery.
However, non-conformance, from a Lean point of view, is an opportunity to improve other processes that are affected by a non-conformance event.
The Quality Inspection Software module allows you to record inspections with as much or as little detail as suits your needs.
Integration with the other modules in The Lean Machine make quick work of getting the inspection set up with all the needed checklist information automatically.
The Calibration Software module allows you to manage equipment and calibration resources and activities.