Computer System Validation

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Computer System Validation

SERVICE

Computer System Validation

Our Focus

Computer System Validation – an ever more complex activity due to the increasing complexity and frequency of change. In most cases Computer Systems are no longer stand-alone solutions. Cloud solutions,  integration of different systems or system hierarchies are increasingly upcoming, as well as changes in regulatory requirements. All these elements challenge the way of  validation. Bear in mind - GAMP5 was released more than 10 years ago, and we are talking about a  fast-moving area. Our goal is to offer CSV services, reflecting the required effort to perform a complete and  demand-oriented validation. Furthermore, not offering indelible generic validation rules or  insisting on any "good" practices if this will give no added value to patient safety or product quality.

Designed Validation

A tailored Computer System Validation supports existing and new implemented computer systems consistently fulfill their intended purpose and produce correct and reliable results that enable regulatory compliance, fulfillment of user requirements, and the ability to discern invalid and/or altered records, using a accurate amount of effort to reach this aim. This can be a balancing act between a time and budget driven implementation plan versus robust and accurate CSV. I2b CSV Factory philosophy is to help to establish a best practice validation methodology enable to fulfill your requirements and not beyond.

SAP Business Process Driven Validation

Computer Systems and especially ERP solutions are business process driven solutions. Customization of those systems is often of utmost importance to fulfill the business process requirements. A static, only functional driven validation often does not catch the entire processes. Often implementation and processes do not comply with process needs or fail even functional units were proper and successful tested. In many cases a process driven Documentation and Computer System Validation set up can help to ensure end to end processes and business aspects are reflected. Not only for the initial implementation, even more for the ongoing operations and change management.

GxP conform SCRUM

More and more IT software development and customization projects using agile methods. Using agile or SCRUM methodologies cause a conflict to the regular way of dealing with CSV. I2b has developed and proven in several projects a GxP conform concept to run partly of full SCRUM or KanBan software development and implementation is possible. Key is to redefine the regular cascade of activities without falling into an incompliant retrospective validation approach. Using multiple system environments to ensure a robust validation can help to have your development and architecture team any time fully utilized without idling.

Cloud/SaaS CSV

SaaS or PaaS hitting the regulated IT world more and more. Unfortunately often existing and new cloud solutions do not fulfill per se all aspects for GxP, GDPR or other compliance requirements. To ensure data integrity, business processes, user management and other critical aspects fit to your (regulatory) requirements, i2b can look back into a long CSV history how to deal with GxP and other regulated conditions, how a cloud validation strategy can be established.

Get in contact.

Björn AdamsComputer System Validation Factory

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