IT Compliance Framework
- Holistic IT Compliance Framework
- Proven Best Practices
- Faster Implementation, less Effort
IT Compliance Framework for the Life Sciences
Due to increasing digitalization of GxP-relevant processes, efficiency in qualification and validation has become an important cost factor. This applies particularly to the outsourcing of IT services, e.g. to the cloud. Increasing validation effort combined with shorter IT innovation cycles leads to disproportionately rising personnel requirements. New concepts for organizing IT compliance create security and help reduce the costs of computer system validation (CSV).
We have now compressed our experience from many complex CSV projects into our IT Compliance Framework as good validation practice. At its core, it is a reference model for designing computer system validation as part of IT quality management.
Comprehensive IT Compliance Framework for Efficient Validation
The IT Compliance Framework includes
- Reference processes as flowcharts with defined interfaces for designing and developing your IT organization
- SOPs aligned to the reference processes for GxP-compliant description of computer system validation
- Essential templates for implementing the processes in your company
Using our framework saves you extensive conceptual and editorial work. You receive expert-reviewed and practice-proven workflows and documents that help you optimize your IT quality management processes. We help you with the design and implementation and, upon request, also take over operational validation tasks in ongoing operations as a service.
Complemented by the VxP Validation Platform, our cloud-based, pre-validated solution for automating validation processes and digitally managing validation documents, you receive a secure, pragmatic and user-friendly “all-inclusive package”.
Managed Validation Services round out our offering. Here, we take over validation tasks in a defined scope based on the framework and enable you and your employees to focus on core IT tasks. This reduces risks and creates full cost transparency in IT compliance with defined service quality.
Use our Digital Validation Scorecard to determine the maturity level of your IT organization and develop your individual roadmap for digital validation with us.
What Does the IT Compliance Framework Include?
Coordinated and modeled processes, documented in all required SOPs for the validation of computerized systems as well as the associated templates for implementing the processes for the project and operational phase of computer systems in the company:
23 setup and service processes, documented in 15 SOPs, with more than 30 associated templates.
- All mandatory activities and functions of computer system validation are defined in the framework.
- It is based on the GAMP 5 V-Model and GAMP 5 System Operation.
- The focus is on systems supporting business processes.
- The framework is system-independent but can be tailored to specific systems.
DHC Consulting Services for the IT Compliance Framework
- IT Compliance Framework “Essential Package”: All SOPs and templates
- IT Compliance Framework “Extended Package”: All SOPs, templates and processes
- Add-on IT Compliance Framework “Advancement Package”: Subscription model with continuous updating / development
- IT Compliance Framework in the VxP – Validation Platform for Life Sciences: Digital delivery of the IT Compliance Framework Essential or Extended in a subscription model in combination with Advancement Package
- Analysis of your IT compliance processes using audits, gap analyses, Digital Validation Scorecard
- Organizational design of IT compliance with conception and implementation of your IT compliance processes
- Compliance-compliant design, implementation and training of all regulatory-relevant documents based on the “IT Compliance Framework”
- Introduction and training of the cloud-based digital VxP Validation Platform
- Updating content and documents of the IT Compliance Framework according to regulatory or legal changes
- Execution of periodic audits/reviews
- Taking over validation services as Managed Validation Service based on the IT Compliance Framework
Why You Should Choose DHC
Benefit from our methodical, process-oriented and risk-based validation approach for software validation!
- More than 20 years of expertise in software validation in Pharma and Medical Technology
- Numerous successfully completed prospective and retrospective validation projects
- Scalable DHC Best Practice validation methodology / validation content
- High audit security
- Strong team of CSV managers with deep knowledge of regulatory requirements (GAMP, FDA, GxP, ISO 13485, …)
- Long-term and trustful collaboration with our clients
- Ensuring knowledge transfer to you as a customer
Trust through Experience
We support leading life sciences companies in efficient and GxP-compliant computer system validation – practical, audit-proof and based on proven best practices.
Would you like to design your IT Compliance efficiently and audit-proof?
Optimize your computer system validation with a field-proven framework and sustainably reduce effort and risks.
