Pharmaceuticals & Medical
operational conditions are constantly indicated and animated. Access to HMI client functions is protected by user authorisations against unauthorised access. Local logging on or logging on via Active Directory can be supported. The chronological event list (CEL) serves as FDA-compliant audit trail. All relevant changes are logged so that they cannot be manipulated. A comment can be saved with every entry. Simultaneously, every access can be logged and traced with a user signature. All information about acknowledging alarms is also logged compliant to the FDA. A batch report is generated for every decontamination cycle or every production charge. It is possible to transfer information via OPC or other standardised software interfaces to superordinate IT systems. The automation solution of the material airlock fulfils all requirements of GAMP 5.0 and fully complies with CFR 21 Part 11. The corresponding software is fully validated in accordance with GAMP 5.0. Additionally, the material airlock meets all GMP requirements for a rapid and reliable material transfer and enables a fully validated and automated transfer process of materials between cleanrooms with different cleanroom grades, or directly into sterility testing isolan tors and RABS.
Industry Europe 155
