An electronic quality management system (eQMS) is a system used to handle all or parts of your QMS. Examples of processes that can become computerized in pharmaceutical operations are: SOP management, CAPAs, deviations, complaints.
Deciding to implement an eQMS is usually a positive challenge. It may help:
- to facilitate availability of documents and enhance search capabilities
- to enable remote work for your employees
- to save space and paper, so environmental benefits
- to save time by automation
- to get the most of your data, being able to more efficiently use it to predict future events
To be compliant with GxP regulations it must be ensured that the use of the eQMS will have no negative impact on patient safety, product quality and/or data integrity – and that it is as reliable as a paper-based system.
Why use our support with building an electronic quality management system
Arex Advisor experts have been involved in a number of successful eQMS implementation projects. We can help you:
- Map/gap current processes
- Identify your company-specific requirements
- Do risk assessment
- Perform supplier evaluation and system selection
- Set up specifications
- Analyze need for migration of documentation generated in previous system
Whilst implementing a QMS, we will:
- Support configuration decisions
- Perform validation
- Develop training materials and train your staff
- Build/update relevant processes (SOPs)
- Perform migration, where relevant
What is the result for you and your project?
By engaging our experts you can save time and add resources to your group for the specific assignment of implementing an eQMS. Once the eQMS is in place you will continue managing the operational phase on your own.
You will gain by:
- ensuring that the final process is manageable from both a practical and regulatory standpoint
- ensuring efforts are proportional to risk level of the system.