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Anmeda RetroN21

Every equipment or machine that is involved in the manufacturing of pharmaceutical products is required to be operationally compliant to meet the CFR Part 11 / Annex 11 guidelines for electronic data processing. Older machines that do not have the in-built capability to meet the CFR Part 11 / Annex 11 guidelines are to be upgraded to enable these machines to be compliant to CFR Part 11/ Annex 11 guidelines such as by user management, audit trails, implementing necessary controls, system validations, electronic signatures, access controls and production data management. This will help you achieve complete regulatory compliance for your production process.

  • > Enables you to adhere to regulatory compliance guidelines, achieve operational excellence and effectiveness

  • > Provides wide functionality to adapt, configure and extend capabilities with enhanced user-friendliness

  • > Flexible and scalable application architecture enabling integration from a single plant to multiple plants

  • > Provides a centralized data platform for machine analytics with expansion capability

  • > Provides data which is configurable based on customer requirements

  • > Open standards support for third-party application integration such as ERP, BMS, Utility management, water plant, etc.

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