Computer system validation

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 solution,

integration of different systems or system hierarchies are increasingly upcoming, as

well as changes in regulatory requirements. All of 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.


service.

Our expertise includes international validation projects for:

 

• Validation of entire SAP solutions / ERP systems

• Track and Trace Validation including SAP ATTP and cloud solutions

• Agile Validation Strategies

• Cloud Solutions Validation (SaaS / PaaS / Iaas)

• Integration roll out approaches

• Disaster Recovery Management

• Change Management including enhanced use of SAP SolMan

• Test Management including managing and administration of Test Tools like HP ALM

• Document Management and document creation / review services

• GxP, GAMP 5 and SOX Trainings

• Data Migration verification

• SharePoint Validation

• Template Management

• Services for Audits (internal and external)

 


achievements.

I2b GmbH has worked with a strong focus on the regulated industries for more than ten years. Knowing IT

systems, as well as the specific approaches of medium to large size pharmaceutical companies and also medical

device organizations, i2b focuses on the demand of interdisciplinary activities between project

management, technical know-how and validation activities.

Aware of this industry has individual demands for smart customized solutions but always with a specific

add-on, to have it delivered on time and with a robust and outstanding quality - i2B is in position to

make this happen. The team has outstanding combined experience of IT/SAP program, project and roll-out

management, system integration and migration, upgrade strategy and an in-depth test and validation

knowledge.

 

Since 2017, i2b can offer a shared work balance strategy to meet the full criteria for optimal costs and

benefits. We achieve additional efficiency through our office in Athens, Greece, where we have a young,

dynamic team of IT specialists with enhanced knowledge in CSV support projects.

 

Being located both in Greece and Switzerland - i2b can combine the possibility of a Swiss top-quality

service for every critical activity, with full support and coordination from our back office.



get in touch with.

Björn Adams / Head of CSV

bjoern.adams@i2b-gmbh.com