Validating software requirements
This client had recently moved their quality system to the Greenlight Guru e QMS platform.
At Minitab, we conduct extensive internal testing to maintain the highest quality of our software products.
We are estimating that about 3-6 months of consulting work is required in order to get our new companies audit-ready.
Our team includes Medical Device software consultants, former ISO 13416/MDSAP auditors, and quality experts, all available to help get your quality system up to speed.
Luckily, the Greenlight Guru electronic quality management system (e QMS) provides users with an easy-to-use application and a validation package that helps support their customers through this process.
As I previously mentioned, I was recently helping a client through their transition audit.Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.