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Technical assistance with the customer during the validation and qualification stages allowed the realization of important guidelines for complex and extremely delicate biomedical products.
Sinteco takes care of customers' needs and provides plants suitable for clean room operation. These plants are in compliance with the new guidelines, such as 21 CFR part 11 and GAMP5.
The whole project is subjected to strict and careful monitoring made up of several stages:
1. Validation package: basic, medium, premium
2. The execution of FMEA, FAT, SAT/IQ/OQ protocols and support to PQ
3. Training in standard practices for the validation
The after-sales service is able to intervene promptly.
Punctuality and efficiency are distinctive features of the production process.
Sinteco offers an after-sales service based on new predictivce technologies utilizing Industry 4.0 which can act promptly, reducing system down time and guaranteeing a high level in operational reliability during the production flow. Technical support is available 24 hours a day.