IT Compliance Framework

Regulatory compliant framework for the
validation of computerized systems

IT COMPLIANCE FRAMEWORK FOR THE LIFE SCIENCES


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.

.

WHAT DOES THE IT COMPLIANCE FRAMEWORK INCLUDE?

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.

DHC CONSULTING SERVICES ON THE IT COMPLIANCE FRAMEWORK

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

DHC – YOUR SPECIALISTS FOR SOFTWARE VALIDATION

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.

WHY CHOOSE DHC?

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
Germany
Matthias Bothe

Managing Director & Industry Unit Manager
Life Sciences, Chemie and Medical Engineering
phone: +49 681 93 666 0
email: matthias.bothe@dhc-gmbh.com

Matthias Bothe, DHC GmbH
Switzerland
Carsten Buri

Director Sales & Marketing
phone: +41 44 500 888 7
email: carsten.buri@dhc-ag.ch

Carsten Buri, DHC AG
Request information

CUSTOMERS

WEBINARS AND EVENTS

11. Juni
Webinar (in German)

QM implementation as part of the digitalisation strategy at Medartis AG

Learn how we have optimised important core QM processes in the course of digitising production and introduced them on the basis of SAP QM.

more
25. Juni
German Webinar

Which QM functionalities does S/4HANA 2020 offer and which not?

Free webinar about the standardized DHC method for software evaluation using the example of QM in S/4HANA.

more
09. Juli
Webinar (in German)

QM in S/4HANA – Example of an integrated LIMS in a Customer Project

Presentation of the quality-relevant processes of a LIMS in a customer project with the help of SAP QM as an integrated overall solution.

more
09. November
Life Online Training

SAP: Validation and GMP Compliance (Live Online Training der ECA Academy)

Online training with speakers from DHC GmbH, organised by Concept Heidelberg on behalf of the ECA Academy,

more
DHC WEBINARS

Our webinars are provided as a free service for DHC customers and potential customers.