CSV & Data Integrity Services
„Specification for computerized systems“
Manufacturing plants or analytical instruments for quality control, are combined with computerized systems (CS) and are software controlled.
Therefore, data integrity, audit trail, authorization, disaster recovery, testing and validation have become key elements to CSV. IT experts need to cooperate with GMP experts and laboratory technicians.
We offer CSV expertise as it pertains for biopharmaceutical manufacturing, analytical laboratories, and their quality control.
Our CSV Expertise
- Proficiency and hands-on experience with analytical instrument qualification, method validation, and process equipment validation
- Ability to interpret regulations and to apply them to the validation operations according to international regulation authorities.
- GAMP
- FDA 21 CFR Part 11
- EU GMP Annex 11
- EU GMP Annex 15
- OECD consensus documentation
- AMG, AMWHV, EU-GMP, MHRA, WHO, FDA
- Data Integrity ALCOA principles
- Data Types (e.g. Phyton)
Our CSV Support
- Preparing validation master plan and validation plans for computerized systems (CS)
- Registration and assessment of computerized systems (CS) and CS-Interfaces
- Risk Assessment of computerized systems (CS) and CS-Interfaces
- Setting specifications for computerized systems (CS) and CS-Interfaces
- Defining and analyzing workflows for computerized systems (CS)
- Designing risk analysis, test plans and test protocols
- Identification and assessment of user requirement and functional specifications (URS, FS)
Your CSV Benefits
- Contributing to GMP compliant computerized systems
- Contributing to quality control operations and quality assurance
- Contributing to Data integrity