CSV & Data Integrity Services
Specifications for computerized Systems (CS) and CSV
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 software validation (CSV).
Objective of CSV & Data Integrity
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 GMP requirements to CSV. IT experts need to cooperate with GMP experts and laboratory technicians.
We offer CSV expertise to your qualification operations for biopharmaceutical manufacturing, analytical laboratories, and their quality control. Our Validation Engineers hold hands-on experience with analytical instrument qualification, method validation, and process equipment validation. They have the ability to interpret regulations and to apply them to the validation processes, according to international regulation authorities.
About CSV
A computerized system describes a hardware, combined with software applications. IT infrastructure is subject to validation regarding a GMP-related environments.
Validation of Computerized Systems (CSV) should be risk-based throughout the entire system lifecycle. A validation team should be formed and responsibilities such as System Owner, Qualified Persons, and Process Owner established. The validation process follows the Qualification Phases of DQ, IQ, OQ, and PQ. System requirements and laboratory needs should be specified in the User Requirement Specification (URS), which are the most essential document of the validation process. Validation specification and acceptance criteria should be established and shuould be risk-based.
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
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)
- Qualification Phase DQ, IQ, OQ, PQ
Your CSV Benefits
- Contributing to GMP compliant computerized systems
- Contributing to quality control operations and quality assurance
- Contributing to Data Integrity
