Silvia Martins, CEO Five Validation is an expert in management and automation systems.
Trained in Computer System Validation in England, Data Integrity and Data Management in Denmark, and SAP validation in Germany.
Silvia has developed specific projects for ERP management systems, DMS, CRM, and implements validation projects pertaining to factory floor production systems involving autoclaves, reactors, environmental monitoring, PW, WFI and quality control labs.
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Validation is one of the important topics for regulatory compliance. Handling the demand for so many validations is one of the topics we will address in this event.
Lack of, or delay in, document preparation and validation testing is one of the issues that prevents faster product commercialization because it impacts factory release, for example.
Digital validation allows 4x faster work compared to paper.
Yes, these days, most validations can be done remotely. Some advantages: healthier staff and quality of life, online management, connect teams between several countries.
It is possible to create documents with standard content coming from libraries containing pre-made validations following market standard guidelines, where the validation professional does not need to start from scratch, speeding up the work.
The main challenge is to keep validation state, which basically contemplates change control and periodic reviews. Digital validation should contribute to easier documentation maintenance.