Enterprise Labelling provides the regulated customer with the ability to design, manage and control label formats. The system manages labels from design through to use and subsequent retirement.
Full revision control is implemented for all formats and elements of each label. Any change or revision to a label or label Element must complete a formal approval process. A full history of all label changes and approvals/ rejections is maintained within Enterprise Labelling.
Each label produced is given a unique identification and a full audit trail is maintained, the system provides for full label reconciliation to be peformed as part of the batch record for a production batch or order.
Enterprise Labelling was developed to GAMP guidelines, is FDA 21 CFR Part 11 compliant and has been implemented and validated successfully in many pharmaceutical sites.
Click here to request a full product brochure, pricing or further information.