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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
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