Complete automation and information solutions

Complete automation and information solutions provide comprehensive automation services from design, supply, construction and commissioning, FAT and SAT testing, and computer system GMP validation.

BIO-YD provides pharmaceutical enterprise MES system, SCADA system, BMS system and EMS system, process control system .

Automatic control system validation service

For pharmaceutical companies, automatic control systems require GMP validation. BIO-YD has many years of xperience in the pharmaceutical industry, using the concept of “full life cycle development” to ensure the quality consistency and service integrity of BMS/EMS/SCADA system engineering projects, in line with relevant GMP regulations.

Computer system validation laws and regulations

US, EU regulations

• 21CFRpart11 (Article 21, Section 11 of the US Federal Law)

• 21 CFRpart 211.68.100a (Article 21, Section 21 of the US Federal Law)

• GAMP5

Chinese laws and regulations

• Computerized System of the State Food and Drug Administration

• China GMP

Computer system check main file list

• URS user requirements description

• RA risk assessment

• QPP quality and project plan

• DQ design qualification document

•IQ installation qualification file

• SAT site acceptance test file

•FS function description

• VR validation plan

•DS design instructions

• FAT factory acceptance test file

• OQ operation qualification file

• Vr validation report