We carry out the identification and analysis of the risks resulting from a deviation from the process variables, with respect to the normal operating parameters of a complete production or installation line. After the analysis, we propose the measures to be taken to eliminate or minimize these risks.
We define the general validation document for a production facility regulated by GMP guidelines, describing all the associated documentation, required maintenance and validation tests to be passed to keep said installation within the required parameters.
We prepare and/or approve the following documentation related to validations: Functional specifications, design specifications, list of inputs and outputs, operating manuals, risk assessment, hardware layout, and other specific documents of the client.
We define, pre-approve and perform the validation protocols (Process, Software and Hardware): Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance qualification (PQ), Communications test, data integrity test , 21 CFR Part 11, FAT and SAT, for each of the elements or processes of a production facility. These tests, or any other that meets the client's needs, can be applied to any industry, whether or not it is governed by regulations of official institutions and they enable us to guarantee the proper functioning or acceptance of the requirements of both the client and standards of quality.
+34 986 410 751
Bajada Gándara, 7, Nave 8, 36330 Coruxo, Vigo
+34 981 601 684
Centro de negocios APEMAX. Avda. Alcalde Manuel Platas Varela 93, 1º Vilarodís - Arteixo
Centro Municipal de Empresas San Fernando de Henares – Oficina 35. Av. de la Vía Láctea 4, 28830 San Fernando de Henares
+351 912 054 481
Avenida da República, 50, 2º andar, 1050 - 196
+1 64 63 74 43 49
100 Overlook Center Princeton, 08540 New Jersey