DeutschEnglish
Monday, 06. February 2012
 
 
Professional Services PDF Print
services

Systec & Services offers a range of professional services to its customers in the pharmaceutical, medical device, cosmetics, fine chemicals and food industries:

  • Consulting
  • IT software solution consulting
  • Process Consulting
  • Project Management
  • Implementation
  • Software Development

Our implementation methodology is patterned on the V model according to GAMP 5 (Good ­Automated Manufacturing Practice) from ISPE / GAMP Forum / APV. It fulfills the strictest legal requirements of the FDA and national authorities ­in the production environment of the regulated ­industry.

Your benefits based on our Know-How:

  • Process management consulting along your value chain
  • Efficiency improvements of implemented solutions
  • Performance assessments – cost reduction through efficient process design in the area of production and packaging
  • Quality Management Assessments – ensuring security
  • IT Governance (Risk, Security and Emergency Management)
  • IT Process Excellence – Security for inspections and audits based on the adherence of the regulatory requirements
  • Computer System Validation (CSV) with innovative and efficient e-Validation Solutions
  • GxP Compliance, 21 CFR Part 11, SOP Management
  • Secure and successful implementation of production management solutions