Solution
Today’s pharma value chain is more complex than ever. Personalized healthcare solutions require smaller batch sizes, higher customization and increase the number of involved parties.
We address those challenges by providing unit level traceability for pharmaceutical manufacturers. The combination of RFID technology with intelligent systems allows you to gain full control of every manufactured unit and the associated data whilst significantly increasing the efficiency during drug product manufacturing and secondary packaging.
Benefits:
Filling
- Increase your batch success rate by 1%
- Knowing exactly which container was filled where and when enables new possibilities to remove or redirect potentially faulty product
Assisted visual inspection
- Save 10 hours per batch during production and visual inspection
- Eliminate manual counting and reconciliation
- Get rid of paper during manual visual inspection and streamline the training and qualification process
Secondary packaging and beyond
- Ensure packaging of the right product in the right quantity without a single visual check
- Easily identify counterfeit products and simplify recalls
Services
We deliver an integrated solution consisting of software, hardware and service components which are designed for the usage in a GMP environment.
Our services cover the full product life-cycle:
- development of the concept and business case
- implementation, configuration and validation
- SaaS operation, support and product enhancements
- potential product retirement
Quality
Quality is at the heart of our products and services. Long-standing experience in GxP environments, aseptic manufacturing and validation of computerized systems allows us to deliver highest quality standards throughout the full product and services portfolio.
The following guidelines are followed during product development and service provision:
- ISPE GAMP5 2nd edition
- ISO 27001
- 21 CFR Part 11
- MHRA GXP Data Integrity Guidance and Definitions