Ingelyt can coordinate and perform all necessary operations from the definition of user requirements to the qualification of all facilities and equipment, among other activities, including:
- User requirements definition (URSs)
- Checking regulatory requirements both internally and with national and international health authorities of facilities
- Making risk map (MaPP)
- Conducting risk analysis and mitigation
- Master Plan Validation
- Drafting and implementation protocols DQ, IQ, OQ and PQ of equipment and facilities
- FAT and SAT performed by suppliers
- Drafting the specification and the site master file
- Making pharmaceutical plans (classification of areas, pressures, flows of materials and people, equipment implementation)
- Support for pharmaceutical local authorities approval (AEMPS, EMA, ANVISA, FDA)
En INGELYT estamos a la vanguardia y somos pioneros en el sector en cumplir con el Diseño, Implantación y Mantenimiento de Planes y Programas de Prevención y Gestion de Riesgos Legales y Penales (CORPORATE COMPLIANCE)