SOLID DOSAGE LINE
OINTMENT DOSAGE LINE
LIQUID SYRUP DOSAGE LINE
DRY GRANULATION LINE
SPRAY DRYERS
SOFT GEL PLANT MACHINE
ANALYTICALS INSTRUMENTS
CAPSULE LINE
INJECTABLE SECTION
SOLID DOSAGE LINE
OINTMENT DOSAGE LINE
LIQUID SYRUP DOSAGE LINE
DRY GRANULATION LINE
SPRAY DRYERS
SOFT GEL PLANT MACHINE
ANALYTICALS INSTRUMENTS
CAPSULE LINE
INJECTABLE SECTION
The 21CFR Part 11 guidelines were defined in 1997 by Food and Drug Administration. These regulations mainly deal with the Electronic Records and Electronic Signature. This was a major step towards defining the equivalence of these records to the legacy Paper based records and handwritten signatures. Along with this guidelines, introduction of Information Technology (IT) in compliance was a milestone.
This regulation defines how paperless record systems compliant with the current good manufacturing practice under which they will be considered equivalent to conventional paper records & handwritten signatures.
The system construction by the user must be based on the following points to comply HMI Platform with the FDA 21 CFR Part 11 regulations.
We have a quality control department to verify each product at different phases, from the procurement of parts to finished products
According to your layout, we can suggest the best capacity and type for you, customize equipment for you
Save energy resource for you, professional engineers can improve the best processing solution. We have the experience to help add a tremendous amount of value to your project
We successfully obtaining the ISO9001:2008 certificate and CE security management system certificate, this is significant for Senieer in building enterprise image
Free Equipment training & maintenance service for you, we will provide your team in-depth training on safe operation and equipment maintenance
Varco Groups offers equipment installation & commissioning service for production products, your equipment and control systems are qualified based on the GAMP life-cycle