CSV & Data Integrity regarding a GMP-related environment
CSV Management
About CSV
- Computerized System Validation (CSV) ensures that computerized systems (CS) are properly designed and installed. Data integrity, data security, testing and system qualification have become key elements to CSV. IT experts need to collaborate with GMP experts, manufacturing staff, QC and QA.
Risk Assessment and Lifecycle
- Validation of computerized systems should be risk-based throughout the entire system lifecycle. A cross-functional validation team should be formed and responsibilities such as System Owners, Qualified Persons, and Process Owners clarified
Integrated Equipment and System Qualification
- CSV is incorporated into analytical instrument and process equipment qualification. System qualification integrates the qualification process into CSV. The purpose to unify CSV and qualification is to save time and elaborate retesting.
Data Integrity and ALCOA+ Principles
- Data integrity aims to verify the data to be accurate, complete, reliable and consistent and to maintain data over time and across formats. Data integrity follows the ALCOA+ Principles.
Operational Qualification (OQ)
- Essential operational testing within OQ, should include software configuration, software customization, software functions, data storage, backup, and archiving.
System Optimization
- Optimizing process flows, implementing solutions and lean validation concepts to system qualification and validation.
CSV Services
- Preparing validation plans and validation master plan for computerized systems (CS).
- Identification and assessment of user requirement and functional specifications (URS, FS)
- 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
- Integrated analytical instrument and process equipment Qualification (DQ, IQ, OQ, PQ).
CSV Expertise
- FDA 21 CFR Part 11
- EU GMP Annex 11
- EU GMP Annex 15
- GAMP 5
- OECD consensus documentation
- AMG, AMWHV, EU-GMP, MHRA, WHO, FDA
- Data Integrity and ALCOA+ principles
- Data Types
Key CSV Benefits
- Coordinating multifunctional teams to qualify equipment, validate computerized systems (CSV) and analytical instruments.
- Ensuring data integrity according to ALCOA+ principles.
- Contributing to GMP compliant computerized systems.
- Contributing to quality control and quality assurance.
Hands-on Experience
Our validation engineers, who are well-qualified, have an understanding of computerized systems, analytical instruments, process equipment, risk factors, and manufacturing processes related to biopharmaceuticals and immunotherapies, allowing us to contribute GMP expertise to your computerized system validation (CSV).
