- Production software
- >Weighing system for formulation sites (SIP/FP)
- >Statistical control of quality and processes (SQC, SPC) software (SIP/CP)
- Laboratory and data acquisition software
- >Data acquisition and information storage GMP/GLP (MINILINK)
- >Data acquisition and keyboard sequence emulator (KS)
- >LIMS (Laboratory Information Management System) (TremoLAB)
- Services and consuliting
- >Service of system validation (Validación de sistemas informáticos)
- >Service of system integration (Integración de sistemas)
Validación de sistemas informáticos - Service of system validation
Before the quality requirements of the market and the need of fulfillment of norms GXP (GMP, GLP, GCP, GAMP) we have applied a system of quality and papers that allows us to offer the whole support necessary for the execution of validations of all our systems.The buyer of Binsol´s software will be able to acquire the following manuals for this process:- Introduction, information and procedures of validation- Guide of Interpretation and application of the CFR 21 part 11 - Translation of the involved norms. - Requests that fulfill them. - Analysis of requests.- QS and QD Qualification of Specification and Design - Cycle of life of the system - Organization - Quality plan - Procedures and methods. - Papers of the development.- QI Qualification of Installation - List of tests and cross-checks to verify that the system is correctly installed.- QO Qualification of Operation - List of tests and cross-checks to verify that the system operates according to the waited in typical and atypical operations.- QP Qualification of Performance - List of tests and cross-checks to verify that the system operates according to the waited in typical operations of the client.
