IT Compliance Framework / Computer System Validation

For many SMEs, the regulatory-compliant development, organization and updating of the QM system in the area of computer system validation is a mammoth task that can hardly be mastered. With our IT Compliance Framework, we provide you with the basis for mastering this task:

Coordinated processes, mapped in all necessary SOPs for computer system validation as well as the associated templates for implementing the processes in your company.

Using our framework saves time-consuming conceptual and editorial work. You receive documents that have been reviewed by experts and proven in practice, which we will be happy to customize and implement for your company with minimal consulting effort.

For many SMEs, the regulatory-compliant development, organization and updating of the QM system in the area of computer system validation is a mammoth task that can hardly be mastered. With our IT Compliance Framework, we provide you with the basis for mastering this task:

Coordinated processes, mapped in all necessary SOPs for computer system validation as well as the associated templates for implementing the processes in your company.

Using our framework saves time-consuming conceptual and editorial work. You receive documents that have been reviewed by experts and proven in practice, which we will be happy to customize and implement for your company with minimal consulting effort.

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Coordinated and modeled processes, mapped in all required SOPs for the CSV as well as the associated templates for the implementation of the processes for the project and operation phase of computer systems in the company:

23 setup and service processes, mapped in 15 SOPs, with more than 30 associated templates.

All mandatory computer system validation activities and functions are defined in the framework.
It is based on the GAMP5 V-Model and GAMP5 System Operation.
The focus is on systems that support business processes.
The framework is system-independent, but can be developed system-specifically.

Content

IT Compliance Framework “Essential Package”:
All SOPs and templates
IT Compliance Framework “Extended Package”:
All SOPs, templates AND processes
Additional IT Compliance Framework “Advancement Package”:
Subscription model with continuous update / advancement
IT Compliance Framework in VxP platform:
Subscription model with Essential or Extended, in conjunction with Advancement Package.

Consulting

Auditing / gap analysis for computer system validation at the customer’s site
Adaptation of the validation framework to business processes/systems
Implementation of the adapted IT Compliance Framework (training, coaching, support)

Services

Takeover of validation services as a managed validation service in succession based on the IT Compliance Framework

Since 1996, we have gained a wealth of experience in the prospective and retrospective validation of a wide range of complex computer systems, such as ERP systems, document management systems, clinical trial software, LIMS, and many more.

We analyse the GxP requirements relevant to you and specify the necessary measures pragmatically based on risk analyses. DHC is characterised not only by its excellent knowledge of computer systems, but especially by its know-how in project and process management as well as its sound industry experience in the life sciences (especially pharmaceuticals) and medical technology.

DHC offers a uniform, methodical, process-oriented and risk-based validation approach. We are guided by the V-model according to the current version of GAMP, the ISO standards and requirements of the FDA (especially 21 CFR Part 11) and the European authorities (especially EU GMP Guide Annex 11). Our approach is tailored to the needs of our customers and fulfils all criteria for a cost and benefit optimised approach. In addition, we take into account the integration into an existing quality management system.

DHC’s portfolio of software validation services is based on a maturity model for the validation of computer systems: services are offered to support strategic planning and methodological design, to professionally carry out software validation and to permanently ensure the valid state of relevant computer systems.

The service offer consists of standardised “consulting packages” pre-defined in their respective scope of services; it also includes flexibly scalable services for the implementation of validation projects and for needs-based support in company-internal validation projects. The focus is on efficiency in implementation and the sustainability of the results achieved.

Benefit from our methodical, process-oriented and risk-based validation approach to software validation

More than 20 years of expertise in computer system validation in pharmaceuticals/life sciences and medical technology
Numerous successfully completed prospective and retrospective validation projects
Scalable DHC Best Practice Validation Method / Validation Content
High audit reliability
Strong team of CSV managers with profound knowledge of regulatory requirements (GAMP, FDA, GxP, ISO 13485, …)
Long-term and trusting cooperation with our customers
Ensuring the transfer of knowledge to you as a customer