Pharmacy - Cosmetics - Medical devices
The pharmaceutical industry, OEM manufacturers of medical devices and all industrial players in the health sector are subject to stringent regulations. But beyond the essential satisfaction of traceability requirements such as FDA 21CFR11, manufacturers in the sector must today take up the challenge of productivity, rapid staff training and the cost of implementation IT solutions mastered. The COOX MES software has been designed to meet these requirements.
Optimal flexibility and productivity imposed by the market
Manufacturers in the pharmaceutical, cosmetology or medical device manufacturing sectors must, due to the nature of their production, demonstrate great flexibility and must be able to act or react quickly to changes (updating on the market of new products, new regulations, etc.).
The implementation of irreproachable and increasingly sophisticated identification techniques is an obligation: the traditional bar code is now replaced by the 2D bar code or by RFID systems. But that's not enough: a manufacturing management solution has become essential.
In addition, manufacturers in the sector are facing increasing pressure on margins, which forces them to guarantee production rates and limit non-quality.
By controlling the production process, by facilitating the execution of operator tasks by assisted operating modes, by obtaining real-time systematic traceability of raw materials and the process, the COOX MES software makes it possible to respond in a reactive manner to the expectations of the market and regulatory requirements, in line with industry standards.
Assistance to operators
The COOX MES software allows the sequence of automatic, semi-automatic or manual operations. The operator is guided in the execution of his tasks by the display of the sequence of operations withe their state of realization and by the integration of associated media: plans, photos, videos.
Electronic signature
In full compliance with international requirements (FDA), the COOX MES software allows the easy implementation at the level of an operation or a group of operations of a verification process by an authorized manager. The identification of operators and verifiers is guaranteed by authentication by login and password or by biometric sensor.
Graphic definition of recipes, manufacturing procedures and quality controls
With the COOX MES software, the R&D department of the manufacturer has full control of the definition of the process and its modifications through a simple and powerful graphic language. The processing of operations in parallel, the conditional execution of operations, the repetition of an operation or a sequence are, for example, easily expressed, guaranteeing total autonomy and great responsiveness. Each modification of the recipe is systematically traced with the author of the modification (audit trail).
Weighing management
Accurate weighing of formulation components is a typical drug manufacturing operation that must be performed, traced and verified with care. The COOX MES software has a set of model operations of this type allowing the direct acquisition of information from a scale and the automated control of weighing tolerances. The passage to the next operation will only be possible for a correct weighing possibly supplemented by other controls.
Exceptional procedures with validation by a manager can be put in placed if authorised.
Electronic Batch Record - EBR
All the operations associated with the manufacture of a batch are systematically traced electronically, with for each operation the equipment or workstation concerned, start and end dates of the operation, setpoint parameters and actual parameters measured for each operation, the identification of the operator and, where applicable, all non-conformities or alerts that occured during its execution. The batch file can be edited in the form of a PDF document with a configurable level of detail.
