Cloud Validation

In the regulated environment of the life sciences industry (pharmaceutical and medical technology), computer systems that have an impact on product quality, patient safety or data integrity must be validated according to legal requirements and kept in a valid state throughout the entire system life cycle. This also applies to cloud-based systems, which are becoming increasingly common in the life science industry.

Cloud computing refers to the provision of IT infrastructure and IT services, such as storage capacity, computing power or application software as a service via the Internet, dynamically adapted to demand.

Chapter 7 of the EU-GMP guidelines also applies to the use of cloud services:

Suitability of the provider must be checked by audits
Service is to be contractually specified
Quality is to be controlled by appropriate measures (monitoring)

A special feature here is that the entire supply chain must be considered, since many providers themselves purchase services as cloud services.

For more than 25 years we have been validating various computer systems for SMEs and international corporations, such as ERP systems (including SAP, Microsoft Dynamics, Oracle,…), document management systems (DMS), laboratory information systems (LIMS), customer developments and spreadsheets (e.g. MS Excel-based applications).
Based on this experience, we have developed a cost-effective and scalable software validation method over the years. The DHC Best Practice Method is a framework consisting of a process model, work instructions (SOPs), templates, training material and tools. It covers the entire system lifecycle from initial implementation, through the operational phase to decommissioning and data archiving.
We have further adapted this method for cloud-based systems. In doing so, we take into account the special characteristics of these systems, such as the reduced user control over the system, management of the service provider or software supplier, protection of data in the system and software changes by the provider

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Compliance Check & Strategy

In a large number of projects we have become acquainted with and optimized various methods for the validation of computer systems. These are basically applicable to cloud based solutions. A critical aspect in the use of cloud based systems is the selection, use and management of service providers and software suppliers. This aspect is especially taken into account here.

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

Supplier selection and qualification incl. supplier or service provider audits
Review of the Master Service Agreements or the Service Level Agreements
Development of validation strategies considering the delivery objects of the Cloud Service Suppliers

Fit-Gap Inspection Readiness Analysis of your validation framework and documentation (Friendly Audit / Compliance Check)
21 CFR Part 11 & EU GMP Annex 11 Assessments
Data Integrity Assessment
Develop remediation plans, such as adapting your risk-based validation strategy to the challenges of cloud-based systems
Conception of validation framework work instructions, templates and training documents
Software validation / 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 cost-effective validation of your cloud-based systems. We validate either according to your work instructions or, if desired, according to the DHC Best Practice Method. We offer the following implementation services:

Qualification or auditing of the cloud service provider
Creation of a service level (SLA) or quality agreements with the cloud service provider
Validation of the software systems and the business processes mapped to them during implementation
Turnkey implementation of Validation-Remediation projects for audit readiness
Software validation method: Framework with work instructions is created, implemented and trained.

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 25 years of experience in this area

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Make use of our experience and industry expertise as a validation specialist

Over 25 years of experience in SAP validation and implementation experience
Large number of successfully implemented 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