DHC Smart Validation Accelerator
- Part of the SAP initiative for the End-2-End Digital Validation Platform
- Focus Life Sciences
- GxP-compliant Methodology
The DHC Smart Validation Accelerator (SVA) digitalizes and automates the validation of your SAP systems.
As a solution extension to SAP Cloud ALM, it supports life sciences companies in efficiently meeting GxP requirements, ensuring auditability and sustainably reducing validation efforts across the entire lifecycle.
Due to new technological, demographic and regulatory challenges, computer system validation (CSV) faces a paradigm shift. Traditional validation methods are increasingly reaching their limits and must be replaced by agile, digital approaches to meet the demands of modern companies.
The DHC Smart Validation Accelerator (SVA) is a validation platform for digitalizing the validation of SAP systems.
It supports companies in regulated industries in efficiently meeting GxP requirements, ensuring auditability and sustainably reducing validation efforts across the entire lifecycle.
Validation Costs You More Than You Think
Excessive Time & Resource Expenditure
Manual validation processes tie up specialist and IT resources for weeks – without real added value for quality or compliance. Projects are delayed, budgets spiral out of control.
Audit & Compliance Risks
Lack of transparency, inconsistent documentation and manual errors increase the risk of findings – with potentially high follow-up costs and reputational damage.
Lack of Scalability
With a growing SAP system landscape (e.g. SAP S/4HANA, SAP Cloud ERP, SAP Digital Manufacturing), manual processes quickly reach their limits – validation becomes a bottleneck for digitalization and growth.
DHC Smart Validation Accelerator - Digital SAP Validation with SAP Cloud ALM
The DHC Smart Validation Accelerator is an innovative, digital validation platform for regulated companies. Through the use of Artificial Intelligence (AI) and full integration into the SAP ecosystem – particularly as a solution extension to SAP Cloud ALM and in combination with test automation – it significantly increases the efficiency of your validation processes.
Validation content of GxP-relevant applications and business processes is automatically created, managed in an audit-compliant manner and kept up-to-date throughout their entire lifecycle.
Technical functions are set in relation to your business processes in a risk and process-oriented manner – and documented in a form that both auditors and business managers understand.
Companies from pharma, medical technology, biotechnology and chemicals make their SAP validation faster, more secure and future-proof – with significantly reduced effort.
The 4 Pillars of Digital SAP Validation
Seamless
SAP Cloud ALM Integration & End-to-End Transparency
SAP Cloud ALM Integration & End-to-End Transparency
Use projects, processes, requirements, test cases and defects from SAP Cloud ALM directly as a basis for your GxP validation. Validation becomes part of your existing ALM process – without isolated solutions and media breaks.
Smart Change Impact Analysis with the Validation Change Analyzer
The Validation Change Analyzer identifies the affected processes and all correlating validation content for a change.
Ideally, the change process – from identification to the change proposal for all relevant content – is automated. The responsible manager only reviews and signs.
Standardisierte, automatisierte Validierungs-
dokumentation
dokumentation
Reusable, GxP-compliant templates and workflows for URS, FS, risk analyses, test plans and reports ensure consistent documents throughout the entire lifecycle. This reduces manual documentation effort while increasing quality.
GxP-Compliance,
Audit-Trail
& Reporting
Audit-Trail
& Reporting
Complete traceability through audit trails, versioning, electronic signatures and flexible reporting. You are inspection-ready at all times and significantly reduce the risk of findings.
Feature Highlights of the DHC Smart Validation Accelerator
Automated validation processes with complete version history, audit trail, electronic signatures and data integrity – ideal for inspections by authorities and customers.
→ Benefit: Minimized compliance risk, stress-free audits.
Pre-built, GxP-compliant templates for planning, specification, risk analysis, test planning and report creation with integrated workflows.
→ Benefit: Significantly less manual effort, consistent documents, higher acceptance from QA and auditors.
Flexible traceability matrices for requirements, risks, tests and results – ideal for audits, reviews and change impact analyses.
→ Benefit: Complete traceability instead of time-consuming Excel searches.
Guided validation workflows with role and authorization concepts, electronic signatures and escalation mechanisms.
→ Benefit: Clear responsibilities, on-time completion, less coordination effort
Integration with SAP Cloud ALM & Test Automation
Use of SAP Cloud ALM as the leading system for ALM information, test management and test automation.
→ Benefit: Validation becomes an integral part of your SAP projects and operational processes – instead of an add-on “on top”.
Would you like to transform validation from a bottleneck
into an enabler?
Business Value of the DHC Smart Validation Accelerator
Accelerated Validation Processes
Reduce validation effort, shorten throughput times and accelerate the market launch of regulated products.
Lower Costs, More Efficient Resource Utilization
Reduce manual effort and sustainably relieve your teams – for noticeably lower validation and operating costs.
Maximum Compliance and Audit Security
Minimize risks through automated audit trails, consistent documentation and complete transparency – for secure audits without stress.
DHC ePaper: 11 Questions about the
DHC Smart Validation Accelerator
Use Cases Benefits & Value
Validation of SAP Cloud ERP Private
- Integrated validation planning and execution based on SAP Cloud ALM data
- Reusable validation modules for releases and change requests
- GxP-compliant documentation with electronic signatures
Validation of SAP Digital Manufacturing (Public Cloud, SaaS)
- Risk and process-oriented validation of cloud-based manufacturing solutions
- Traceable change history and automated impact analysis
- Accelerated approval processes with high audit security
GxP Compliance and Audit Assurance – Integrated from the Start
The DHC Smart Validation Accelerator supports you in reliably and efficiently meeting regulatory requirements – with integrated compliance and complete auditability.
Our many years of experience in implementing and validating complex IT systems in the life sciences industry have been incorporated into the DHC Smart Validation Accelerator. This applies to both the validation methodology, which continuously evolves and meets current GxP standards (GAMP 5, Annex 11, 21 CFR Part 11, …), as well as the automatically generated content such as URS, FS or test plans.
More Information about the SAP Initiative
End-2-End Digital Validation Platform
GxP Compliance and Validation of the
DHC Smart Validation Accelerator
The DHC Smart Validation Accelerator itself is developed and validated according to GxP standards and can be seamlessly integrated into your validation concept. DHC supports you in:
- classifying the SVA risk-based into your system landscape,
- defining the required validation activities and documents, and
- demonstrating the auditability of the solution to authorities and customers.
This ensures that not only your SAP systems, but also the validation tool itself meets regulatory requirements.
Clarify your validation requirements directly with our experts.
Integration & Technology – Made for SAP & Regulated IT Landscapes
Ready for Digital Validation?
The DHC Smart Validation Accelerator supports Life Sciences Industry companies in ensuring a valid system at all times – efficiently, integrated and future-proof.
