Frequently cited MHRA GMP inspection observations

Paper-based, process-driven delays are no longer an issue for Ci-DMS MES customers ($300B in value lost in 2018*). Our MES solution highlights deviations, enabling batch release by exception and interfaces with the Enterprise Resource Planning (ERP) system to automatically update stock records. A global pharmaceutical manufacturer saves half a million key presses per year by automating stock updates at their Singapore facility.  *Source: various including McKinsey & Co & Pharmaceutical Engineering.

With increasing demands for higher output, and lower overheads, can you afford the costs associated with a batch failure? (typically, 47% First Pass Yield (FPY) rate (zero defects) in paper-based pharmaceutical manufacturing*) Ci-DMS MES uses the Right FIrst TIme method, manufacturing errors/deviations are highlighted when they occur, and the batch cannot be continued until the issue is resolved, safeguarding against batch failure and increasing the FPY rate. A global Ci-DMS MES customer saves in excess of $400K per year and avoids two potential failed batches per month in their USA plant. *source: various including McKinsey & Co & Pharmaceutical Engineering.

Upwards of $1.77 can be added to the cost per a drug package as a result of the high levels of investment needed to comply with the Falsified Medicines Directive (FMD)* Ci-DMS MES is configured and validated for compliance, electronic records and processes improve data integrity whilst reducing our customers’ overheads associated with maintaining compliance. In most cases, a return on investment is achieved within one year. *source: Capgemini Consulting

For many paper-based manufacturers Cost of Goods Sold (COGS) is at least 27% of sales and can be as high as 45%*. Much of this cost is in post-batch analysis and reporting and is often an intense and demanding activity requiring highly trained people. Ci-DMS MES extensive and real-time management reporting capabilities significantly reduce the costs of post-production analysis. Electronic records improve data integrity, reduce the risk of human error, and electronic signatures ensure FDA / EMA compliance. *source: Various including McKinsey & Co and J Pharm Innov