Computer systems validation

Whether it comes to dose or weigh systems, manufacturing devices, track and trace systems or electronic signatures – companies in the pharmaceutical industry always benefit from automation of their production. However, these IT projects are subject to Computer Systems Validation (CSV): a regulatory requirement that provides documented evidence that an IT system works as expected.

QbD is the expert in Computer Systems Validation, often referred to as Software validation, for the life-sciences industry. With help of the GAMP 5 ® methodology (developed by ISPE), we guide you through the whole process of CSV. In doing so, we always use a risk-based approach. This pragmatic, efficient way of testing and validating guarantees that your budget is spent the right way. In the meantime, we have helped numerous enterprises to comply with the standards of FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA / COFEPRIS and other authorities.

What do we validate?

All computerized systems that have an impact on product quality, patient safety and data integrity. Adequate CSV consists of various aspects – from planning, system verification and validation to testing, traceability and configuration management. This applies to the validation of product or device software, as well as to the validation of software used to design, develop or manufacture devices and products.

QbD makes a difference in CSV

QBD has over 8 years of experience in Computer Systems Validation. Our competences include training in Project Management, Qualification and Validation of Computerized Systems based on Risk Management (according to the GAMP 5®), Good Manufacturing Practices (GMP), Process validation and quality management systems. This ensures the correct planning and execution of your validation project.

QbD’s CSV experts are experienced in validating pharmaceutical computer systems and pharmaceutical software, including:

• Manufacturing Execution Systems (MES)
• ERP Systems (SAP, JD Edwards …)
• Laboratory Information Management Systems (LIMS)
• Electronic Batch Record (EBR)
• Manufacturing Resource Planning Systems (MRP)
• Lab system software (HPLC, FTIR, GC, etc.)
• Document Management systems
• SCADA systems

Contact Us Now

Interested in Computer Systems Validation? We support you throughout the whole process. From writing a validation plan to the formulation of user requirements and their translation to functional and technical specifications, and testing and validating your system. All of this in close cooperation with Reditech, our trusted partner in automation.