SOFTWARE VALIDATION

Methodical, process-oriented and risk-based
DHC Best Practice Validation Method

IT Compliance

SOFTWARE VALIDATION


In the regulated environment of the life sciences (pharmaceutical and medical technology), computer systems that have an influence on product quality, patient safety or data integrity must be validated according to strict national and international legal requirements and kept in a valid state throughout the entire system life cycle.

Regulatory requirements include EU directives and national drug laws as well as the quality management standard DIN EN ISO 13485 and the requirements of the US Food and Drug Administration (FDA). For pharmaceutical companies, the regulations from 21 CFR Part 11 and EU GMP Annex 11 are also relevant. In most cases, the validation itself is carried out according to the industry standard GAMP 5.

DHC has more than 20 years of experience in the validation of the most diverse complex computer-aided systems.


These include ERP systems (SAP, Oracle, Microsoft Dynamics), document management systems (DMS), laboratory information and management systems (LIMS), IT systems in the clinical sector / clinical trial management systems, pharmacovigilance systems, customer developments, spreadsheets and cloud-based systems.

With the experience gained from a large number of successful validation projects, we have developed over the years a cost-effective and scalable method for the validation of computer systems. The DHC Best Practice Method is a framework consisting of a process model, work instructions (SOPs), templates, training materials and tools. It covers the entire system lifecycle – from initial implementation, through the operational phase, to decommissioning and data archiving. We are constantly expanding our methodology to include solutions for new regulatory and technological challenges (e.g. machine learning or artificial intelligence)

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DHC CONSULTING SERVICES FOR SOFTWARE VALIDATION

Compliance Check & Strategy

In a large number of projects we have become acquainted with and optimized various methods for the validation of computer systems. Based on this experience we have developed the DHC Best Practice Method.

Our consultants are happy to support you competently in the following topics:

  • Fit-Gap or Inspection Readiness Analysis (Friendly Audits / Compliance Checks)
  • CSV Framework Check: Checking your validation framework and validation documentation for completeness and efficiency
  • 21 CFR Part 11 & EU GMP Annex11 Assessments
  • Data Integrity Assessment
  • Development of remediation plans, e.g. adapting your risk-based validation strategy to new regulatory requirements
  • Design of software validation strategy and framework including work instructions, templates and training materials
  • Software Validation / IT Compliance Workshops
  • Development of test strategies
  • Development of data migration and verification strategies
  • Coaching of QA / validation managers
Validation Services

The core of our Validation Services is the risk-based and economical execution of software validation.

  • Qualification of the IT infrastructure: This forms the foundation of the validation of computer systems. We ensure that your IT infrastructure components are qualified in accordance with the audit.
  • Prospective validation: Software systems and the business processes mapped to them are validated during implementation.
  • Retrospective validation: Software systems in productive use and the business processes mapped to them are validated during operation.
  • Turnkey implementation of Validation Remediation projects for audit readiness.

We either validate on the basis of your work instructions, work with you to develop your own method or have our DHC Best Practice Method in our luggage.

Our Validation Services include the assumption of all validation activities – from project management to document creation – and include

  • Creation of validation strategy, plan and report
  • Creation / Review of Life Cycle Documents
  • Requirement management and process mapping
  • Project Management
  • Training Management
  • Test Management
  • Data migration and data verification strategies
  • Change management
  • Periodic Review
  • Supplier management
  • Audits of suppliers and service providers

Managed Validation Services

With our “Managed Services for Validation” the effort and costs of IT Compliance can be reduced and made transparent. Depending on the initial situation, we offer service packages in the area of Managed Validation Services that are specially tailored to your customer requirements. These range from targeted support (Validation as a Service = VaaS) to a full service package

Depending on the desired level of support, we provide the necessary compliance concept, methods and resources for achieving and maintaining IT compliance. In doing so, we rely on more than 20 years of experience in this area

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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 that are relevant for you and make pragmatic recommendations for actions to take on the basis of risk analyses. DHC’s work in this area is not only characterised by our excellent computer system competencies but in particular by our know-how in project and process management, as well as long-standing industry experience in life sciences (particularly pharmaceuticals) and medical technology.

DHC offers a uniform, methodical, process-oriented and risk-based approach to validation. We orient ourselves here on the V-Model according to the latest version of GAMP, the ISO standards, and the requirements of the FDA (especially 21 CFR Part 11) and European regulators (especially EU GMP Guide Annex 11). Our approach is tailored to the needs of our customers, and meets all of the criteria for a cost- and benefit-optimised methodology. We can also handle projects requiring integration with an existing Quality Management system.


The portfolio of CSV services offered by DHC is based on a maturity model for the validation of computer systems. Services are offered for the support of strategic planning and conceptual method design, for the professional execution of software validation, and for the long-term assurance of the valid state of relevant computer systems.

Services are offered as a standardised ‘consulting package’ that is predefined in terms of its service scope: the package also includes services that can be scaled flexibly in order to complete validation projects or offer on-demand support as needed for company-internal validation projects. Priority is given here to ensuring efficient execution 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
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