Process Validation and Continued Process Verification as a Service
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The new FDA-Guidance demands strictly Continued Process Verification (CPV) for process validation in all relevant stages of the lifecycle of any product. EMA follows accordingly for Continuous Process Verification. This makes it necessary for manufacturers to electronically collect and treat growing amounts and increasingly detailed process- and product-data in order to survey and optimize processes and products through Critical Process Parameters (CPP) and Critical Quality Attributes (CQA).
PANDA (Process Analysis Database)
Atris Information Systems offers with its system PANDA a complete solution for Continued Process Verification. This allows treating big amounts of data of different origin (LIMS, PDA, EBR, etc.) and structure with the opportunity of consolidation and aggregation as well as multiple evaluations and graphical representations.
PANDA Private Cloud
As well as an in-house solution Atris Information Systems offers PANDA in a private cloud service.
- Hard- and software-resources needn't be held by the customer
- Open interfaces allow importing of customer's data
- Adaption to changing demands of public authorities and technical evolution
- Individual solutions on costumer´s demand
- Consulting concerning demands of public authorities
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