Expertise is provided in the following areas:

• CSV (Control System Validation)
• Process and Equipment Qualification and Validation activities
• Automated systems – DCS, SCADA, PC and PLC-based, Legacy Systems, HMI, Distributed I/O
• Laboratory Systems Validation
• Quality Systems (including Training / Calibration / CAPA / Documentation)
• Regulatory Compliance – including QSR 820, 21 CFR 210 ands 211, 21 CFR Part 11
• Packaging, Sterilization, Lyophilization, Solid Dose, Parenterals
• Control System development and implementation
• Commissioning / Validation / Auditing
• IQOQPQ development and execution
  
• Network and Server Qualification activities
• Remediation of Legacy Systems
• Electronic Records and Signatures
• Database Development and Implementation Services