Sebald Consulting provides customized engineering services and specializes in FDA and EMA regulated companies including pharmaceutical, medical device, biotechnology. We work with your team to support your project objectives in a manner consistent with your company culture and fill in where necessary. Some areas of expertise include: Automation Computer System Validation (CSV) Software and Control System Design 21CFR11 , Annex 11 and GAMP support Establishing Calibration, Validation, or Maintenance programs Root Cause Analysis and Process Improvement Equipment commissioning and validation