Karriere
Kom med på holdet

Case

IT validation

Medical cannabis manufacturer

Challenge

  • 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.
 

Solution - Proces

  • 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.

Results

  • 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.
#Pharma #Validation #IT #Laboratory #VirtualSupport

Kontakt os og hør mere om hvordan Genau & More kan hjælpe dig og dit firma

Michael Holt

Konsulent
IT & Automation / GAMP, GMP, Facilities & Equipment Validation, Computer System Validation

Læs mere om