Ensure safety and quality

Medical technology and healthcare market:
Effective validation processes

Meet regulatory requirements, increase efficiency and quality

Software used in the development, manufacture, storage, trading and maintenance of medical devices and pharmaceuticals must be validated.

Successfully master validation

We support you in validating your business processes mapped on the software side: through various services and the provision of our Validable ERP software. If you wish, we will accompany you until the successful validation of your ERP system.

Why choose us

KUMAVISION has more than 25 years of practical experience in validating computer-based systems - both in national and international environments.

CSA: An advanced approach for greater security and efficiency in validation

In many validation projects, extensive documentation is created - without questioning whether this level of documentation is necessary and offers added value for patient safety or product quality. 

But that need not be. Thanks to Computer Software Assurance (CSA), validation can be carried out more specifically and therefore more efficiently. The documentation effort is significantly reduced by focusing on the relevant processes.

Computer Software Validation versus Computer Software Assurance

Computer Software Assurance is a consistent continuation of the risk-based approach of computer system validation (CSV) and places a strong focus on critical thinking, automation and the integration of the Cloud-Providers or suppliers.

At the same time, it offers a proven solution for validating new technologies such as Artificial intelligence/Machine Learning (AI/ML), Cloud Computing or even that Internet of Things (IoT). Thanks to high-level test automation, the validated status can be continuously verified, even with regular software updates. This makes it possible for the first time to use software-as-service solutions in medical technology in a compliant manner.

Computer Software Assurance offers you these advantages

More efficiency

CSA enables faster validation of computer systems by avoiding unnecessary bureaucratic burdens. This results in accelerated adoption of new software or updates and helps bring medical devices to market more quickly.

More future security

With CSA, companies can respond more quickly to new technologies and regulatory changes. Validation no longer becomes a barrier to innovation, but rather a supporter of progress.

Cost less

Automating testing and performing validation efficiently can reduce costs without compromising security or compliance.

More quality

CSA focuses on the critical aspects of the software that are critical to patient safety and product quality. This allows potential risks to be specifically identified and eliminated.

VitalAire validation with KUMAVISION

Success Story
Validated software implementation

Find out how the homecare service provider VitalAire simplified and successfully completed validation with KUMAVISION.

  • Numerous best-practice approaches to validation
  • Comprehensive support through solutions with industry-specific functions and workflows
  • Setting up release workflows
  • Comprehensive document framework with numerous templates

With us, validation loses its horror

We actively support you and accompany you in validating your business processes implemented in the software in accordance with the GxP/ISO guidelines. This ensures compliant system integration and ensures that you meet all national and international requirements with certainty.

Consulting package “Kick-off validation”

One-day workshop to determine status at your location.

  • Required and existing documentation is compiled.
  • You will receive a comprehensive and tailor-made validation roadmap.

Document package for validation including training

Enables you to introduce fully validated software according to CSA with little effort.

  • Comprehensive document package based on ERP business processes
  • Validation plan, validation checklist and validation report
  • Process list (BPML) including risk assessment according to GAMP 5 2nd Edition, requirements and specification of each process
  • Supplier audit questionnaire

All details of the document package will be explained to you in detail in a half-day training course.

Individual advice as required

We are happy to support you depending on your individual customer needs

  • Participate in the validation process (document review, change management support)
  • office hours

We advise you on:

  • EN ISO 13485
  • GAMP® 5 Guide 2nd Edition
  • Computer Software Assurance (CSA)
  • Computer System Validation (CSV)
  • critical thinking

Good to know: KUMAVISION ERP is fully capable of validation

KUMAVISION ERP for medical technology manufacturers and medical device retailers is capable of validation and supports you company-wide in meeting regulatory requirements. The industry solution is based on many years of experience in the regulated environment and offers numerous industry-specific functions for medical technology:

  • Compliance support (ISO, MDR, GMP or FDA)
  • Continuous updates in the background, 40.000 automated tests to ensure compliance
  • Graded user authorization concept
  • Four-eye principle with workflows for approval Audit trail (complete tracking of changes)
  • Quality Management (QM)
  • Risk and complaint management (RuB, FMEA)
  • Validation archive and document control with integrated, audit-proof document management system (DMS)
  • Supplier Evaluation
  • Tracing of serial and batch numbers (traceability)
  • Unique Device Identification (data records, label printing, upload to EUDAMED/GUDID)
  • Electronic device file (Medical Device File)
  • ISO compliant processes

Validation from A to Z

The FAQs were provided to us with the kind support of VQC Consulting.

Change control / change control / change management

A formal process by which qualified representatives from the disciplines involved review proposed or implemented changes to a computer system. The main goal is to document the changes and ensure that the system is maintained in a controlled state.


Complete transfer of data to another computer system with the aim of using the data in the new system in the future.

Do you have any questions or would you like to talk about a project?