Ensuring compliance and quality with Computer System Validation.

In highly regulated industries the reliability and accuracy of computerized systems are essential to maintaining compliance with stringent regulatory standards. Computer System Validation (CSV) plays a crucial role in safeguarding product quality, ensuring patient safety, and preserving data integrity. By validating your systems, you can avoid costly errors, mitigate risks, and enhance operational efficiency.

At Westernacher Consulting, we specialize in CSV services guided by Good Automated Manufacturing Practice (GAMP® 5) standards. Our experienced team ensures your computerized systems meet regulatory requirements while upholding data integrity, product quality, and operational excellence. We provide tailored validation solutions designed to address the unique needs of regulated industries.

Trust Westernacher to help you achieve compliance and maintain the highest standards of quality and safety.

Safeguard product quality and patient safety

Maintain high product quality standards as the system consistently performs as expected

Compliance

EU GMP Vol. 4, Annex 11
US FDA CFR Title 21 Part 11

Operational efficiency

Automation and integration within validated SAP systems reduce manual interventions, minimize errors, and streamline operations

Westernacher Computer System Validation (CSV) services and support.

CSV services

Functional and technical specifications
A risk-based approach to functional testing
Design review
Traceability matrix, test plan
Testing, testing deviations
Change management
Installation qualification
Hypercare issues

CSV support

Validation planning
Validation workshop
User requirements specification – GxP and data integrity
A risk-based approach to user acceptance testing
User acceptance testing deviations
Validation reporting
Validated system maintenance in operation

Our Validation Practice is Aligned with the SAP Implementation Methodology.

Experience the advantage of a fully integrated approach.

Integrated Expertise

Expertise in both compliance and ERP that reduce the risk of compliance gaps or rework later

Streamlined Communication

Reduce the complexity of communication
No need to coordinate between multiple parties
Reduce delays, misunderstandings, or misalignment of goals

Faster Implementation

Timelines are more efficiently managed with one vendor responsible for both validation and system implementation

Consistency in Documentation

Uniformity and consistency in documentation are assured
The set of documents meets both SAP system needs and regulatory compliance standards

Regulatory Compliance from Start

Compliance is built into the system design – GxP (Good Practice) requirements: data integrity, audit trails, and security
Risk of post-implementation compliance issues is reduced

Reduced Risk

Risk of gaps in responsibility or accountability is reduced
The integrated approach minimizes the potential for errors or missed steps during validation or system implementation

Ensuring compliance and quality with Computer System Validation.

Westernacher Computer System Validation (CSV) services and support.

Our Validation Practice is Aligned with the SAP Implementation Methodology.

Experience the advantage of a fully integrated approach.

Let's work together.

Quest

Get in touch with our experts.
Stay informed.

Subscribe to our newsletter and stay informed about our latest insights.

Use of cookies

Westernacher uses cookies to provide you with a more responsive and personalized service. By using this site you agree to our use of cookies. Please read our cookie notice for more information on the cookies we use and how to delete or block them.

Ensuring compliance and quality with Computer System Validation.

Westernacher Computer System Validation (CSV) services and support.

Our Validation Practice is Aligned with the SAP Implementation Methodology.

Experience the advantage of a fully integrated approach.

Let's work together.

Quest

Articles

Get in touch with our experts. Stay informed.

Subscribe to our newsletter and stay informed about our latest insights.

Use of cookies

Westernacher uses cookies to provide you with a more responsive and personalized service. By using this site you agree to our use of cookies. Please read our cookie notice for more information on the cookies we use and how to delete or block them.

Get in touch with our experts.
Stay informed.