SOFTWARE VALIDATION

A methodical, process-oriented and risk-based validation approach to software validation

IT Compliance

SOFTWARE VALIDATION


An increasing number of industries are now being required to validate their IT systems in terms of product quality as a result of national and international legislation.
These regulatory requirements include EU directives and national medicinal product laws, as well as the DIN EN ISO 13485 quality management standard and requirements stipulated by the US Food and Drug Administration (FDA). For pharmaceutical companies, the regulations provided for by 21 CFR Part 11 and EU GMP Annex 11 are also relevant for computer system validation. The validation procedure itself is usually carried out in accordance with the GAMP 5 industry standard.  


The software validation procedure provides documented evidence that a system can fulfil the previously specified requirements over its entire lifecycle.

DHC can draw on its long-standing experience in the validation of a wide range of complex computerised systems. These systems may include ERP systems (SAP, Oracle, Microsoft Dynamics), document management systems (DMS), laboratory information management systems (LIMS), IT systems used in a clinical context/clinical trial management systems, IT service management systems, pharmacovigilance and facility management systems.


DHC CONSULTING SERVICES FOR SOFTWARE VALIDATION

Compliance Check

We draw up a fit/gap analysis of your GxP compliance on the basis of a friendly audit, and we evaluate risks and opportunities. The results are presented to you as a GxP compliance roadmap with recommendations for implementation, an estimate of effort and a rough schedule.

  • Fit/gap analysis of IT compliance on the basis of a friendly audit/compliance check
  • Analysis and evaluation of processes and procedures for the implementation and operation of computerised systems
  • Development of a business case for GxP compliance
  • Assessment of risks and opportunities
  • Recommended measures for implementation/further development of GxP compliance
  • Analysis of the level of support required (rough planning of the required resources, skill level of resources available internally in relation to CSV, scope and skill level of external resources required)

We have developed best practices for you based on our long-standing validation and sector-specific experience. These give you a responsive and structured project process while ensuring cost-effectiveness is not neglected.

These include:

  • Policies and SOPs for the implementation of computer-aided systems
  • Policies and SOPs for the operation of computer-aided systems in a regulated environment
  • Templates

The SAP Solution Manager and the add-ons developed by DHC for Solution Manager (Document, Change and Test Management) give you a framework that facilitates the paperless validation of your IT system. To this end, our preconfigured solution consistently implements the DHC validation method and closes GxP gaps in standard SAP functionality.

Validation Services

Our DHC validation services include the end-to-end handling of all validation activities, from validation management through to document creation.

We can coach you and/or take responsibility for the design and implementation of validation activities. This also includes your vendor audits.

  • Creation of a validation strategy, the validation plan and the validation report
  • Coaching, planning and execution of prospective and retrospective validation projects, including test management planning and execution
  • Operational support for the creation of lifecycle documents
  • Support during test management
  • Operational support for the creation of test specifications and during the documented execution of tests
  • Review of validation documents
  • Qualification of the IT infrastructure and IT services
  • Risk management
  • Project team training
  • Training management as part of the project
  • Audits at vendors and service providers

In the process, we support you with materials and tools we have developed on the basis of our long-standing validation and sector-specific experience. These give you a responsive and structured project process while ensuring cost-effectiveness is not neglected. These include:

  • Policies and SOPs for the implementation of computer-aided systems
  • Policies and SOPs for the operation of computer-aided systems in a regulated environment
  • Templates
Managed Validation Services

We handle the task of maintaining GxP compliance for you, and carry out the duties normally performed by a Compliance Manager. You can focus on your core activities in IT, while we assume responsibility for IT validation work as a ‘contract validator’.

  • Change management
  • Periodic reviews
  • Implementation of other topics/requirements, including data integrityGDP complianceIDMP compliancecloud validation, etc.
  • Validation management
  • Formal and contextual document control
  • Document workflow tracking
  • Coaching for documentation, risk assessment, audits, IT changes, tests, etc.
  • Audit preparation
  • Audit execution
  • Monitoring of the effectiveness and continuous improvement of the Quality Management system (QM manual, processes, SOPs, etc.)

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

  • Over 20 years of expertise in software validation
  • A wide range of successfully completed IT validation projects
  • Long-term successful working relationships with our customers (services)
  • Acknowledged sector expertise in pharmaceuticals/life sciences and medical technology
  • A wealth of expertise in regulatory requirements (GAMP, FDA, GxP, ISO 13485, etc.)
  • Proven DHC validation method/validation content
  • High level of knowledge transfer

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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CUSTOMERS

WEBINARS AND EVENTS

06. September
German Webinar

Datenintegrität und computergestützte Systeme

Vorstellung der Anforderungen an die Datenintegrität computergestützter Systeme gemäß ALCOA sowie deren Umsetzung in Validierung und Betrieb.

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17. September
English Webinar

From SAP ERP to SAP S/4HANA

How do changes in S/4HANA, SAP’s new ERP system, affect GMP compliance?

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08. November
German Webinar

Prüfmittelverwaltung und -überwachung mit SAP

Vorstellung der in SAP integrierten Prüfmittelverwaltung mit allen Funktionen für die unternehmensweite Verwaltung betrieblicher Prüfmittel

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12. November
English Seminar

SAP: Validation and GMP Compliance

Seminar with speakers from DHC GmbH, organized by Concept Heidelberg on behalf of the ECA Academy, Steigenberger Hotel Berlin

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22. November
German Webinar

Validierung von SAP S/4HANA Enterprise Management

Neue Compliance Aspekte und Wege zu SAP S/4HANA sowie Vorstellung der prozessorientierten, risikobasierten DHC Methode auf Basis von SAP Activate

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29. November
German Webinar

APQP, FMEA und PLP mit SAP QM

Vorstellung der verschiedenen SAP Werkzeuge zur Abbildung von APQP und Darstellung von SAP PPM, FMEA, Kontrollplan, Prüfplan und Qualitätsmeldung

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06. Dezember
Webinar

SAP QM als integriertes Laborinformations- und Managementsystem (LIMS) in der Life Sciences

Vorstellung von LIMS-Funktionen des SAP QM sowie Integrationsaspekte zu Einkauf, Lagerung, Produktion und Vertrieb

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DHC WEBINARS

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