| When GxP-related processes are supported by a computer system which handles GxP-related data, the system must be validated. With our integrated and pragmatic approach we can validate software in one pass and define and implement operational IT service processes required to maintain the validated status of the systems. We meet the regulatory requirements of the EU, FDA and Swissmedic and, where applicable, other national authorities, plus ISO 13485. We follow the guidelines of the EMEA, PIC/S, GAMP, APV and the current Special Interest Group (SIG) of the ISPE. |
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Starting point
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Introduction or upgrade of an ERP, LIMS, MES, DMS, CTMS, PK/PD, PVS, EDC, eSubmission or of systems developed in-house
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Applications created in Excel and Access must be validated
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Changes to legislation mean that applications that have already been introduced require validation
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It is not clear whether a system, which is to be introduced, is GxP-related and therefore may need validation
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Our contribution
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Coaching, planning, coordination and implementation of prospective and retrospective validation projects including testing/test processes
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Analysis and specification of GxP-related requirements
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Risk assessments and traceability
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A combination of our validation, application and IT knowledge with your business and configuration expertise
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Knowledge of the appropriate regulations and the latest trends
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Your benefit
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Customer-specific and pragmatic approach
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Requirements-based support (control or implementation of the validation project)
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Knowledge of the guidelines and many years of experience in the validation of different applications
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In-depth IT, pharmaceutical, biotech and medical device expertise
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