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Production equipment Qualification and Computerized System Validation.

You can contact us for Software Validation, Computerized System Validation, Medical device validation, Equipment qualification, FDA, GAMP5, GMP, GLP, ISO17025, ISO13485, ISO80002, PIC / S, 21 CFR Part11, EU GMP, EU Annex, EMEA, ICH.

Based on FDA, 21 CFR Part 11 and Annex Regulations requirements, DATA INTEGRITY & ALCOA Principles Computerized System Validations of your laboratory and data-generating systems; Design, Setup, Operational and Performance Validation operations (DQ, [...]

Forced Degredation Study & Analytical Method Development & Analytical Method Validation Trainings

Medical Device Embedded Softwares, Production & Finance and Quality System Management Softwares must be validated according to ISO80002, ISO 13485, IEC/EN 62304 regulations. You can use our extensive experience for these requirements. Please con[...]

Please contact with us for "Embedded Software Validation" studies in scope of IEC / EN 62304 regulations.

Data security is a requirement of 21 CFR Part 11, Annex 11, ISO 13485. The necessity of quality systems is the requirement of regulation and the validity of the storage areas. We perform Cloud Validation studies in all sectors that produce validated [...]