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System Validation

System Validation:
Validation of Your Computer Systems.

Validation of your computer systems is not only a regulatory requirement, but also supports the need-based implementation of your infrastructure and applications. Based on the processes to be supported and user requirements, specification and testing ensure that your systems do exactly what you need them to do throughout their entire lifecycle.

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Why Validation?

System Validation: Security Throughout the Entire Lifecycle

As Detailed as Necessary and as Efficient as Possible

In many IT organisations, there is still the impression that validation is carried out for validation's sake and costs time and money without providing benefit. This need not be the case. Agile validation concepts enable initial validation in parallel with system implementation, as well as maintaining the validated state within regular system maintenance and change activities. A risk-based approach allows you to focus on what is essential.

machCon as a Partner, Not a Controller

By making use of documentation from the respective system suppliers, risks can often be reduced and the validation effort within your own organisation minimised. As a partner that supports you in building and implementing the relevant processes, machCon can generate tangible added value for your IT operations.

Data Migration

And What About the Data?

Secure and Compliant Data Migration

When changing systems, data often needs to be migrated. We help you define which data should be migrated and how the migration can be carried out securely and in compliance with regulatory requirements. Mapping data flows, involving data owners and validating the migration path are all part of a coherent concept.

GxP Data and Audit Trails

The migration of GxP data should be carefully considered and clearly documented so that, for example, audit trails continue to be available. Thanks to our many years of experience in mergers and acquisitions of IT organisations in a regulated environment, we can support you reliably.

Our Services

Our System Validation Offering

As part of our system validation services, we offer you the following services.

CSV Support

machCon plans computer validations of IT applications and IT infrastructure according to your existing guidelines and processes, and carries out the validation reliably together with the corresponding documentation.

Guidelines & Processes

We analyse which regulatory requirements (21 CFR Part 820, 21 CFR Part 11, EU GMP Annex 11, ISO 13485, etc.) are relevant for your company and IT organisation, and support you in deriving appropriate measures and mapping them in guidelines and processes.

Data Migration

machCon offers tailored concepts to ensure data integrity and regulatory compliance throughout the entire lifecycle of the data and the computer systems involved, and supports you in implementation.

System Selection

A neutral external perspective can be helpful to ensure that a new computer system fits the business process and integrates seamlessly into the existing system landscape. It should also be checked in advance whether the system and the suppliers are suitable for meeting regulatory requirements (e.g. CSV, audit trails).

Periodic Reviews

Periodic reviews of validation documentation, intended to maintain the validated state of the computer system, can uncover and resolve errors and derive optimisation potential. A review by an external machCon expert can be particularly valuable here.

IT System Retirement

The replacement and decommissioning of an IT system is often underestimated. In addition to terminating licences, it also involves securing the data stored in the system: this must either be transferred to a new system or archived. After successful migration, it must also be ensured that the data is removed from the legacy system in accordance with the data classification.

Our Clients

What Our Clients Say

Fantastic Business Analysts!

" I'm absolutely happy to have machCon onboard within my projects. They have an incredible drive and are solution oriented while keeping a friendly and positive working atmosphere. "

Process Integration Lead

Novartis Pharma AG

machCon is like TopGun's Maverick!

" I have to say that I totally love working together with machCon — they have very good Project Managers & Coordinators as well as great Business Analysts and Technical Experts. "

Head of Global TechOps IT

Roche Pharma Research IT

Highly Qualified Project Managers

" I was collaborating with machCon for a large scale project and was absolutely satisfied with the performance. The Project Manager did a great job & integrated smoothly with the whole team. "

Head of Laboratory IT

Sandoz International GmbH

System Validation: Secure and Efficient.

Talk to our experts about your next validation project. We look forward to the exchange.

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