EXPERT KNOWLEDGE

Computer systems validation

Qualification services for your automated computer systems

What is computer system 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.

Which systems 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.

Support throughout the whole validation process

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 Yitch, our trusted partner in automation.

Outsource your CSV activities for maximum return on investment

Our validation solution guarantees maximum return on investment by delivering the following key benefits:

Quicker delivery times

By using our best practices, we help to accelerate your validation effort. These best practices are based on years of experience in SAP validation.

Cost-effective

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.

Regulatory authorities’ approval

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.

An off-the-shelf validation solution for you

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:

  • User requirements
  • Validation plan
  • Risk assessment
  • Technical documents (FS/DS)
  • Traceability matrix
  • Installation qualification
  • Operational qualification
  • Performance qualification
  • Validation summary report

Quality Management Software

We make quality management easy

The first cloud-based and pre-validated Quality Management Software built for Life Sciences. Writing down your quality processes is one thing, but making sure everybody is aware of them and following-up on events, CAPAs and a plethora of related actions is what keeps QA people awake at night. With QualityKick™ you can reclaim your peaceful nights again.

Experts in validation

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:

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Computer System Validation Course

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