Efficient electronic batch documentation is one of the most important objectives in introducing an MES to pharmaceutical production. With PAS-X Electronic Batch Recording all MBRs are electronically executed and the processes and results are documented in compliance with the applicable statutory provisions. PAS-X EBR ensures an error-free and guided execution of the entire production process and right-first-time manufacturing.
The past years have seen rapid growth in the number of cell therapy products in late stages of clinical trials. However, moving closer to market-approval brings significant operational challenges for companies as their patient populations grow. Electronic systems are emerging as the only option for managing large patient volumes. Werum’s PAS-X MES is ideally suited to target the key challenges for Cell & Gene therapy manufacturers.