Validation

The above stated activities are a part of the portfolio of many companies, operating in the field of automated control systems. But not all of them may guarantee that the client really gets what he wants and needs. The company UNIS improves the level of its services by strict securing of quality based on generally and globally approved standard GAMP5 (Good Automated Manufacturing Practice).

Our primary aim is to arrange for the final manufacturing process to be performed in expected way and for the parameters of resulting products to meet the requested criteria. In other words, the whole realisation of the project is aimed at one target: the resulting system of manufacture and its control to be put into validated status and to be kept in such status. In the course of the project realisation there is developed all and any needed documentation topped by the validation report at the moment of the project finishing, so as – at the moment of take-over – the project is ready for audit performance by an appropriate controlling authority. You can find more on validation here.

Systems supplied by the company arrange inter alia the following:
  • detail monitoring of the product (series, batches) in the course of the whole manufacturing process,
  • long-term keeping of manufacture history, i.e. real conditions under which the product has been manufactured (records on individual production steps, materials used, procedures, course of key technologic features, etc.),
  • strict protection of data against loss and unauthorised access.

The company UNIS also performs validation and preparation for audit performance for systems, supplied by other suppliers.

The company UNIS operates in the sphere of validation just for several years. The services have been used by many leading pharmaceutical and chemical companies, performing projects that are currently ready for an audit performed by the American FDA, while some of them have already successfully passed the audit. You can find detailed information on validation references here.
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