Network Validation including firewalls, routers, switches, layout, cabling, security.
21CFR Part 11 Audits, Assessment, Remediation, SOPs and Training
Control systems for sterile/biotech equipment/systems including lyophilizers, sterile/bioreactors, filter systems, filter integrity test systems, pressure/temperature controls, packaging systems and environmental controls.
Laboratory systems including ovens, coolers, freezers, environmental controls, laboratory information systems (LIMS), chromatography data collection systems and instrumentation. Other instruments validated include: UV-Vis spectrometers, FT-IR spectrometers, high performance liquid chromatography (HPLCs), gas chromatographs (GCs), and capillary electrophoresis systems (CEs).
Information management systems including electronic documentation management systems, laboratory information management systems (LIMS), maintenance management systems (MMS), manufacturing resources planning system (MRP II, ERP), order management systems (OMS), supervisory, control and data acquisition systems and (SCADA) systems and manufacturing execution systems (MES).
Bulk pharmaceutical manufacturing processing trains including reactors, blenders, centrifuges, dryers, temperature controls, vacuum/pressure controls, dispensing controls, and automated sequences.
Distributed Control Systems (DCSs) used to control and monitor environmental, bulk, secondary and sterile processes.
Programmable Logic Controllers (PLCs) utilized to control pharmaceutical process equipment.
Database management systems including Oracle, Sybase, MS SQL server, DB/2, and MS Access.
Computerized Clinical Data Acquisition and Management Systems.
Solid dosage, ointments, creams, liquids and sterile packaging lines including check weighers.
Pharmaceutical blenders, mixers, granulators, dryers, tablet coating systems and tablet presses