Shifting from a manual paper-based system to an eQMS can be an overwhelming process without the right support and planning. Cortrium relied on the extensive cooperation and support from the SimplerQMS team. This support included training, assessment of IT systems readiness, and system validation. The support provided to Cortrium, as is the case of all SimplerQMS`s customers, was provided at no extra cost.
“During the implementation, the cooperation with the SimplerQMS team was excellent. We had regular meetings with the team, and they were always available to support us – which is also the case after going live on the system,” says Louise Ehlert, Process Manager at Cortrium.
Cortrium followed SimplerQMS`s formula of incrementally implementing the eQMS system. This is done to avoid a “big-bang” project, where too many people and processes are involved in the process. In this way, Cortrium started harvesting the efficiency benefits in a matter of weeks instead of waiting for many months.
“The first project included all our technical files, procedures, and templates. Then we took it step-by-step, and finished implementing the Post-Market Surveillance Tools, adapting all our procedures and templates in just 4 weeks,” says Louise Ehlert, Process Manager at Cortrium.
Cortrium`s advice for successfully implementing SimplerQMS:
- Dedicate a specific project manager to the task
- Be critical of the documents that will be migrated to the eQMS, this an opportunity to clean-up your archive
- Implement step-by-step, procedures and forms first. Then technical files and Post-Market Surveillance.
- Involve the IT manager in the process, this is to ensure that AD synchronization and Microsoft Azure are aligned