The Pharmaceutical Industries are probably the ones that require the most stringent “regulatory” regime; so it is imperative the Data Integrity Monitoring in an area in which, as in all other types of Industrial Production Companies, remains central the Control of Raw Materials and Production.
The area of research and development also plays a key role.
The LIMS has to be integrated with ERP / MES Systems and can be useful systems for the computerized management of the Dossier Packaging.
All the Software that somehow is involved in Business Process Management needs to be Validated.
Not only the Software Packages C.O.T.S., but also those made within the company or from third parties, as well as all logical and formulas developed with the support of Spreadsheet.
The Standards Reference are GxP, GMP, FDA-CFR 21 Part 11, Annex EU-11, ISO 13485.
That’s why, in addition to the LIMS and the stand-alone SW Packagesfor the Metrological Confirmation, the Warehouse Laboratory and Data Acquisition from Instruments, equipped with a “Validation Kit” which certifies compliance with these regulations, Polisystem Informatica developed Software Packages dedicated to the validation area:
Since the Validation activities are often difficult and expensive, it can sometimes agree to entrust outsourced services that Polisystem Informatica offers for Software Validation, Validation of Logic of Excel, the realization of instruments Calibration protocols.