QMSL – Vision28 LEAN Quality System
Vision28 professionals have experience developing and defending quality systems in companies whose sizes range from Fortune 100 world-wide companies to start-ups trying to get their first product approved by FDA.
What we have found over the years is that overly complex systems hamper the basic mission of the company and may expose the company to compliance risk! If you write something in a procedure, FDA will expect you to follow your procedure and any deviation will be seen as a violation.
Vision28 QMSL is a complete 21 CFR 820 or 21 CFR 820 and ISO 13485 compliant quality system. Paper based, it is ideal for start-ups and growth phase companies who don’t want to spend significant dollars for a medical device quality system, and who want to get a system up and running in weeks instead of months. Couple it with Vision28’s cloud-based eQMSL for document control and management reporting and you have a complete Quality System and Document Control Solution for your enterprise. Below are a few screenshots from eQMSL to give you a feel for the system.
This figure shows the main eQMSL screen. Native documents, such as .docx and .xls documents, are stored in this data table along with approved .pdf documents. This is where approved procedures, forms and work instructions are stored and controlled.
eQMSL Quality Record tab houses all the completed forms for equipment calibration and maintenance, material specifications, incoming IQA records, signature log, risk documentation and quality system logs.
The complaint module records both Complaints and Medical Device Reports. It has the feature of recording the main and secondary causes of the complaints, and identifies the components of the FDA definition of a complaint that classifies the customer communication as a complaint, as opposed to an information inquiry. eQMSL automatically creates aging reports and frequency charts for causes. These frequency charts may be used in Management Review, thereby saving time and standardizing Management Review presentations.