The new version of the Amebis Control Software contains many features. The main additions include a networked database and the ability to download the software from our website. The software also contains many new additions for the presentation of data to the user. With the new version of the software it is now possible to use the Amebis Stability Testing & Monitoring System as your primary source of data for stability testing from developmental work right through to finished product and post marketing batches This includes continuous mapping of cabinets and monitoring of the environmental conditions for test material during transportation. It is therefore possible in the context of ICH Q10 for a product to achieve a state of continual improvement by quality access to significant real time data as facilitated by Amebis technology. In addition, the concepts of process analytical technologies (PAT) and Quality by design (QbD), currently applied to pharmaceutical manufacturing, could also be extended to include stability testing utilising Amebis technology.

Accelerated Stability Assessment Programme (ASAP)

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