In life sciences production, numerous different machines and types of equipment are used in the production process. For all of these devices, parameters (recipes) need to be set every time a new medicine or batch is produced.
Today, recipe management can be a time-consuming process that requires many manual actions from different stakeholders and a large amount of paper-based documentation. That can result in low process efficiency and a high potential for mistakes and makes it harder to achieve regulatory (GMP) compliance.
The recipe management process of today exposes life sciences companies to many challenges and risks:
- Risk of inconsistent recipe parameter values on different reports and violation of data integrity principles
- Repetitive and time-consuming recipe handling for machines and equipment
- Excessive FTEs allocated to process due to additional check of manual actions
- Immense risk for (human) errors and production deviations
- Threat to product quality and medicine safety due to manual data entry errors
- Paper-based and time-consuming recipe life cycle management (changes, approvals, versioning, etc.)
- More complex documentation, qualifications and validations due to dispersed GMP data storages
- Limited data storage for recipes on machines, staff needs to be additionally trained to handle it (perform manual backups)
- Limited access to the data with low potential for analyses and improvements
To overcome aforementioned challenges and risks, recipe management has to be digitalized and centralized. This can be done with advanced recipe management software for life sciences industry MePIS RM.
Stay tuned for more information about how to optimize your recipe management process – in the next edition, we will cover the key features of MePIS RM!