Computerized System Validation (CSV)
A Simple Path to Reliable Systems and Secure Compliance
Validation of computerized systems is essential to ensure that systems function correctly, meet regulatory requirements, and handle data in a secure and traceable manner. We support organizations in validating, structuring, and securing systems throughout their entire lifecycle.
Challenges
Common challenges
Complex requirements for systems, data, and regulatory compliance
Validating computerized systems involves ensuring functionality, data integrity , and regulatory compliance in complex IT environments. Challenges often arise from the interplay between regulatory requirements, technical solutions, and the need to maintain control throughout the system’s entire lifecycle.
Lack of relevant expertise in validation
Collaboration between suppliers and internal teams
Inadequate documentation that does not meet regulatory requirements
Difficulty in maintaining a life-cycle perspective
data integrity , and Traceability Shortcomings
Difficulty in determining which parts of the system are critical according to GMP
We Offer
Effective Validation of Computerized Systems
Ensures proper operation throughout the system's entire life cycle
We help organizations validate computerized systems to ensure they function correctly, meet regulatory requirements, and are tailored to the needs of the business. A risk-based approach ensures a focus on critical functions and the efficient use of resources.Throughout the system’s entire lifecycle—from implementation to operation and updates—we contribute to reliable systems, structured documentation, and secure data integrity.Validation of computerized systems
Validation of systems in accordance with GAMP, GxP, and CFR to ensure proper operation and regulatory compliance.
Validation During System Updates
Validation during system upgrades to ensure that changes meet regulatory requirements.
GAP analysis
Identification of non-compliance with regulations and regulatory requirements.
Risk-Based Validation
Risk-based reviews of critical system functions to ensure the appropriate scope.
Documentation and Validation Plans
Structured documentation and validation plans that ensure traceability and compliance.
Education and Professional Development
Guidance and support to strengthen internal expertise in the validation of computerized systems.
Value We Create
Reliable systems that meet regulatory requirements
Risk-Based Validation with a Focus on Critical Functions
Efficient processes that reduce rework and delays
Reduced risk of deviations and operational disruptions
data integrity s throughout the entire system lifecycle
Long-term system performance and stability
Customer cases
Here's How We Overcame Past Challenges
Validated eQMS with Secure Data Migration
Problem: Following the implementation of Veeva e-QMS, the client needed to ensure that the system met regulatory requirements and could be used effectively in its operations. At the same time, the migration from the old system required a high degree of accuracy to avoid compromising the “ data integrity ” and traceability.
Solution: We implemented and customized Veeva’s document management and training modules and performed a full validation in accordance with applicable regulations. At the same time, we managed the data migration and trained users to ensure a smooth transition and proper use of the system.
Results: A validated eQMS with properly migrated data provided the customer with a secure and efficient platform for quality management. The solution strengthened regulatory compliance, reduced risks, and laid the groundwork for a more efficient and scalable operation.
Validation of computerized systems
Validation of systems in accordance with GAMP, GxP, and CFR to ensure proper operation and regulatory compliance.
Validation During System Updates
Validation during system upgrades to ensure that changes meet regulatory requirements.
GAP analysis
Identification of non-compliance with regulations and regulatory requirements.
Risk-Based Validation
Risk-based reviews of critical system functions to ensure the appropriate scope.
Documentation and Validation Plans
Structured documentation and validation plans that ensure traceability and compliance.
Education and Professional Development
Guidance and support to strengthen internal expertise in the validation of computerized systems.
Common challenges
-> Lack of relevant expertise in validation
-> Collaboration between suppliers and internal teams
-> Inadequate documentation that does not meet regulatory requirements
-> Difficulty maintaining a life-cycle perspective
-> Shortcomings in " data integrity " and traceability
-> Difficulty in determining which parts of the system are critical according to GMP
Features and benefits
-> Reliable systems that meet regulatory requirements
-> Risk-based validation with a focus on critical functions
-> Efficient processes that reduce rework and delays
-> Reduced risk of deviations and operational disruptions
-> Reliable data integrity throughout the entire system lifecycle
-> Long-term system performance and stability
CONTACT
Talk to someone who knows your area
Marleen Dekker Scaffolding
Head of Unit Pharma and Biotech
Marleen Dekker Scaffolding
Head of Unit Pharma and Biotech
Karin Tördahl
Head of Unit Quality & Validation
Karin Tördahl
Head of Unit Quality & Validation