SimplerQMS has more than 30+ years of experience implementing software in life science companies. We are ready to help, no matter if you are about to build your QMS, already have a "paper-based" QMS on a file drive or if your QMS is fully digital.
We use the following proven process, which ensures quick and thorough implementation. Thereby, we deliver a validated system, under change control and which runs on a qualified data center ready for regulatory audits and inspections.
"We have approached other eQMS vendors, but none of them had the nessesary knowledge about the regulatory requirements in our industry. SimplerQMS speaks and understands the same 'regulatory language' as us. Furthermore, their ISO 13485:2016 certification is an important stamp of approval."
Our project manager prepares a plan and helps assign your employees to the key SimplerQMS processes. An online design workshop is held where we complete the following tasks:
SimplerQMS is configured according to the user requirement specification including future document templates. A test version of SimplerQMS is made available for your users with agreeded security settings.
These steps are completed during the Training & Test phase:
SimplerQMS is now ready for production. We are therefore ready to complete the following steps: