EXPERT KNOWLEDGE
Computer systems validation
Qualification services for your automated computer systems
Qualification services for your automated computer systems
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.
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.
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.
Our validation solution guarantees maximum return on investment by delivering the following key benefits:
By using our best practices, we help to accelerate your validation effort. These best practices are based on years of experience in SAP validation.
Any system implementation is a large investment, and even more when validation is required. With our validation solution, we aim to keep your validation budget under control.
State-of-the-art validated computers systems will stand the test during audits and inspections. Regulatory issues can be time-consuming and troubling events that carry many business risks, such as delays in authority’s approval of new products.
We make it easy for you. As an alternative to manual and project-based labour-intensive validation efforts, QbD Group´s ready off-the-shelf pre-packaged validation solution incorporates industry compliance best practices.
It includes the following deliverables:
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 computer systems and software, including:
Receive detailed information from one of our experts.
