Managing complex ‘needle to needle’ processes
If a sample is out of specification, there may not be opportunity to manufacture another. Therefore, it is extremely important to meet time constraints and to achieve right first-time, every time, for every patient. Ensuring the right patient gets the right treatment includes tracking and ensuring chain of identity (COI) for each patient throughout the ‘needle to needle’ process. Similarly tracking chain of custody (COC) ensures chronological documentation that records the sequence of custody, control, transfer and analysis – not just in manufacturing but throughout the logistics and treatment processes.
To manage COI and COC, MES systems use material tracking technology and also make sure that patient kits and lot genealogy are tracked and fully traceable. MES enables manufacturing automation which reduces the amount of manual processing steps per batch and leads to faster review times.