IT & Embedded Systems

IT & Embedded Systems

IT Services for Computer System Validation and Data Integrity

The IT services which GxP-CC offers, cover the complete IT systems architecture from the IT infrastructure to the applications running on those architectures. This also includes embedded systems. In addition to these services our security specialists can protect your systems against external and internal security breaches of the systems.

Strategic Software Validation Planning

Together with our clients we endeavor to improve the overall validation strategies and methodologies, thus ensuring a lean, consistent and compliant approach toward strategic software validation of IT systems.

We offer an improved strategy, which helps reduce the effort in various validation projects, which we undertake together with our clients. For example, we will introduce a risk-based approach to the validation and focus more on testing, thus leading to a reduction in the overall number of documents required for validation projects.

Risk Management, as stipulated by the FDA and ICH Guides, is a powerful tool aiding in the overall validation effort.

We provide a clear and focused set of templates for Guidelines and SOPs that will help make validation an integrated part of your project.

Validation of Application Software

GxP-CC has experience in a wide range of systems such as:

  • ERP (including SAP© & Oracle©)
  • CAQ
  • LIMS
  • Document Management
  • Requirements Management
  • Customer-Specific Applications & Databases

We provide our clients with a full spectrum of service from Project Management through the definition of procedures and documentation, specification and verification, and finally to validation. Also included are all other supporting activities necessary to keep your IT systems in a validated status.

Quality Management of IT Systems

An integral part of our services includes the system security activities required to protect your system.

The GxP-CC methodology for integrated Quality Management for IT systems offers our clients a consistent approach from the guidelines and valid regulations to the processes you require in order to achieve compliance for your IT Systems. This methodology covers all levels of IT from hardware to application software including all the system layers between. An integral part of our services includes the system security activities required to protect your system.

Validation of Embedded Software

The validation of embedded software requires thorough knowledge of both the software and hardware of the IT system in question. In this vital area, GxP-CC supplies the necessary expertise to support our clients in all phases of the development lifecycle.

Qualification of Infrastructures and Their Components

Infrastructure is the basis for all IT operations. Regardless of whether your company has an internal IT department or an outsourcing contract with an external IT supplier, GxP-CC provides the expertise necessary to work with your company to identify a cohesive, tailored solution for your business purposes.

IT Security Architecture

IT Security and the requirements thereof, is in increasing demand not only within the pharmaceutical and medical device industries but also virtually in all other technically driven industries. Our knowledge, experience and expertise can help you prepare and install a consistent and effective security concept including all system levels of hardware and software. This protects your data against internal and external attacks and any other kind of manipulation.

Discover how to strategically validate your IT systems at reduced costs. Contact Us About Your IT & Embedded Systems