IT validation

Medical cannabis manufacturer

The manufacturer requested support for the validation of software that control and manage laboratory equipment at their site in Denmark.
Requirement specifications and validation plan had to be prepared prior to validation activities.
The workload on employees should be minimized.
All work had to be completed off-site due to COVID-19 pandemic.

Due to the COVID-19 pandemic a weekly meeting was established in MS Teams. This included consultants from Genau & More and the manufacturer’s employees responsible for IT and Quality Control.
The scope/framework and timeline of the project was established.
Each software was described in a validation plan, and configuration/ requirement specifications, and validation protocols were approved.
In order to save time and simplify the process all documents were based on templates established and approved early in the process.
All validation activities were performed remotely via a VPN-connection to the manufacturing site.

All (status) meetings were held in MS Teams where scope and timeline were updated, and comments and review of documents were performed using shared desktops.
Our project scope and spent hours were concurrently adjusted to the needs and capacities at the manufacturer.
All validation activities were completed and concluded in relevant reports and approved documents in MS Word/pdf were delivered for all software in scope.
The manufacturer is now supplied with an adjustably template for requirement specification and qualification protocol for future software in similar laboratory equipment.