Computer System Validation

Maintaining a realistic, risk-based approach

Beginning with the end in mind, Azzur takes the regulatory principles of CSV guidance and establishes benchmarks for each system or asset against safety, quality, and system integrity. From there, we employ a realistic, maintainable, and risk-based approach to compliance, taking into account all aspects of your in-house and enterprise systems.

Our CSV/CSA Services Include:

Global Business/Supply Chain Management Systems Compliance

At Azzur, we understand the business needs of corporate environments. The combination of our knowledge of business systems with our regulatory compliance experience allows us to provide comprehensive solutions to the FDA-regulated industry.

Manufacturing Systems Compliance

Our validation consultants provide assistance with Systems Validation, Control Systems Technology, Building Management Systems, Computer Integrated Manufacturing (CIM) and Manufacturing Execution Systems (MES) Compliance.

Laboratory Systems/Instruments Compliance

Whether the need is for validation of laboratory systems (e.g. Laboratory Information Management Systems (LIMS)), or Chromatography Data Acquisition Systems for qualification of instruments, Azzur can provide skilled, experienced consultants to handle the work.