Outsourcing Computer Systems Validation

Outsourcing Computer Systems Validation

SAP validation projects are often time-consuming, high-risk, demanding in terms of resources and therefore very expensive. That’s why QbD offers a pre-packaged validation solution for your SAP applications: we apply standardisation and compliance in a timely and cost-effective manner. We provide everything you need, whether you are implementing SAP for the first time, moving from a legacy system or applying operational change control.

The benefits of standardisation

The SAP R/3 pre-packaged validation solution was created based upon the QbD Group’s extensive life science industry knowledge and know-how amassed from years and years of experience within pharmaceutical, biotech, medical devices and ATMP enterprises. QbD Group’s SAP R/3 compliance pre-packaged validation solution helps you to comply with local and international regulations (e.g. FDA, EMA, COFEPRIS and INVIMA) in a timely and cost-effective manner.

Our pre-packaged validation solution helps you to be confident and to fully trust the systems you are using. It provides all evidence required to demonstrate that the intended use of the application is aligned with your business processes.

We make sure the systems are doing what they meant to do, and most important: that there is no impact on patient safety, product quality or data integrity.

QbD Group compliance offering

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

iReValid: our full maintenance programme

Right next to our validation package, we can offer iRevalid – an annual license to maintain the validated state of your system. Our programme assures robust validation documentation. Updated documentation is provided in line with regulatory compliance. We provide:

  • An annual regulatory evaluation
  • Periodic review ¹

Jointly, iReValid and our CSV and data integrity QbD consultants provide an all-inclusive SAP R/3 compliance solution. The delivery time for the iReValid service is very short. In case of gaps or anomalies, a more thorough remediation program can be initiated. iReValid should also fit with the company’s operation excellence / continuous improvement programme.

Maximum return on investment

This SAP R/3 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 SAP R/3 implementation is a large investment, and even more when validation is required. With our pre-packaged 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.

Whether you are implementing SAP for the first time, moving from a legacy system or applying operational change control, QbD group’s pre-packed validation solutions will help you manage your SAP related compliance risks rapidly and consistently.

QbD Group also offers separate SAP validation and compliance solutions for SAP Business ByDesign and SAP Business One.

¹ Periodic review. The purpose of the Periodic Review is to ensure that the computer system remains compliant with regulation, is fit for its intended use and satisfies company policies and procedures.


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