Outsourcing Computer Systems Validation
Validation projects are often time-consuming, high-risk, demanding in terms of resources and therefore very expensive. That’s why QbD offers a standarized solution for your systems applications: we apply standardisation and compliance in a timely and cost-effective manner. We provide everything you need, whether you are implementing your system for the first time, moving from a legacy system or applying operational change control.
Maximize your return on investment
Why outsourcing is the right answer? 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.
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The benefits of standardization
The validation solution outsourcing 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 compliance validation solution helps you to comply with local and international regulations (e.g. FDA 21CFR part 11, EMA Annex 11, COFEPRIS and INVIMA) in a timely and cost-effective manner.
Our 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 outsourcing 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 solution, we offer iRevalid outsourcing – an annual service 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 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.
Whether you are implementing SAP, QualityKick, Veeva, LIMS, MES… for the first time, moving from a legacy system or applying operational change control, QbD group’s outsourcing validation solutions will help you manage your system related compliance risks rapidly and consistently.
- Manufacturing Execution Systems (MES)
- ERP Systems (JD Edwards, SAP 4/Hana SAP R/3 SAP Business ByDesign and SAP Business One, Microsoft Dynamics…)
- 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
- CRM (Salesforce…)
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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