CSV & Data Integrity Services
Specifications for Computerized Systems (CS)
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, analytical instruments, devices and utilities used for quality control, drug manufacturing or drug development are nowadays mostly combined with computerized systems.
Data integrity, data security, audit trail, authorization, disaster recovery, testing and validation have become key elements to CSV. IT experts need to collaborate with GMP experts and laboratory technicians..
About CSV
A computerized system describes a hardware with software combined applications. According to GAMP, the software is categorized into groups to determine the scope of validation.
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.
The validation process follows the Qualification Phases of DQ, IQ, OQ, and PQ. System specifications and laboratory’s requirements should be specified in the User Requirements Specification (URS).
The URS is one of the most essential documents within your validation process. Validation specifications and the associated acceptance criteria should be established on a risk basis.
Essential operational testing within OQ, should include software configuration, software customization, software functions, data storage, backup, and archiving.
Key Benefits of CSV
We offer CSV expertise for biopharmaceutical manufacturing, analytical laboratories, and their quality control. Our Validation Engineers hold hands-on experience with analytical instrument qualification, method validation, and process validation. They have the ability to interpret regulations and to apply them to the validation operations according to international regulations.
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.
ALCOA Principles
ALCOA is the abbreviation for: Attributable, Legible, Contemporaneous, Original, and Accurate. This term was originated by the FDA and incorporated into the guidelines
Regulatory Requirements of CSV
IT-Infrastructure is subject to validation regarding a GMP-related environment. CSV principles of validation of computerized systems include GMP regulations and requirements e.g. FDA 21 CFR Part 11, GAMP, EudraLex Vol. 4 Annex 11, EudraLex Vol. 4 Annex 15, Datatype, ALCOA principles, and a risk-based system classification.
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 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
Your CSV Benefits
- Contributing to GMP compliant computerized systems
- Contributing to quality control operations and quality assurance
- Contributing to data integrity