Computerized System Validation
Computerized System Validation and Data Integrity in a GMP-related Environment
GMP Regulations and Guidelines
- GAMP 5
- FDA 21 CFR Part 11
- EU GMP Vol. 4 Annex 11
- EU GMP Vol. 4 Annex 15
- ALCOA+ principles
- USP <1220> Analytical Procedure Lifecycle
- USP <1058> Analytical Instrument Qualification
- Eurachem Guide: Analytical Equipment and System Qualification
About Computerized System Validation (CSV)
A computerized system (CS) describes a hardware with software combined applications. According to GAMP, the software is categorized into groups to determine the scope of validation.
Integrated Analytical Equipment and Sytem Qualification into CSV
Analytical instrument, process equipment and system qualification follow the integrated approach which combines qualification activities and CSV. The purpose to combine CSV and operational qualification (OQ) is to save time and effort.
Data Integrity
Data integrity aims to verify the data to be accurate, complete, reliable and consistent and to maintain data over time and across formats.
Operational Qualification (OQ)
Essential operational testing within OQ, should include software configuration, software customization, software functions, data storage, backup, and archiving
Key Benefits
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).
We offer CSV expertise in a GMP-related environment. Our Validation Engineers hold hands-on experience with analytical instrument, process equipment and system qualification. They have the ability to interpret regulations and to apply them to the validation operations according to international regulations.
Our CSV Services
- 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)
- Qualification Phase DQ, IQ, OQ, PQ
Our 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, ALCOA+ principles
- Data Types
Your 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.