System Validation
Validation of your computer systems
System Validation: Be sure computer systems are doing what they’re supposed to
The validation of your computer systems is not only a regulatory requirement that must be met, but also supports the needs-based implementation of your infrastructure and applications. Based on the processes to be supported and user requirements, specification and testing can ensure that your computer systems do exactly what you need them for – and that it stays that way over the entire life cycle of the computer system.
As detailed as necessary – as efficient as possible
In many IT organizations there is still the impression that validation is done for the sake of validation and costs time and money with no benefit.
It doesn’t have to be like this. Agile validation concepts allow initial validation parallel to system implementation and maintaining the validated status as part of regular system maintenance and change activities. A risk-based approach allows you to focus on the essentials.
By using the documentation of the respective system suppliers, risks can often be mitigated and the validation effort within your own organization can be minimized. As a partner who supports you in setting up and implementing the relevant processes, machCon can generate noticeable added value for your IT operations instead of the tiresome obligation of validation.
How about the data?
When changing systems, data often has to be migrated.
We’ll help you narrow down what data to migrate and how to make the migration safe and compliant with regulatory requirements. The mapping of the data flows, the integration of the data owners and the validation of the migration path are part of a coherent concept that does not lose any data that you will need later.
The migration of GxP data in particular should be well thought out and clearly documented so that audit trails, for example, continue to exist. Thanks to our many years of experience in mergers and takeovers of IT organizations in a regulated environment, we can provide you with reliable support.
Our System Validation Offerings
As part of our System Validation Services, we offer you the following items.
CSV Support
machCon plans computer system validations of IT applications and IT infrastructure according to your existing guidelines and processes and reliably carries out the validation together with the corresponding documentation.
Guidelines & Processes
We analyze for you which regulatory requirements (21 CFR Part 820, 21 CFR Part 11, EU GMP Annex 11, ISO 13485, etc.) are relevant for your company and your IT organization and support you in deriving the appropriate measures and to map them in guidelines and processes. Even for computer systems that do not have to be validated according to the requirements in the regulated environment, validation can ensure that the intended use of the computer system is fulfilled.
Data Migration
machCon offers you needs-based concepts to ensure data integrity and regulatory compliance over the entire life cycle of data and the computer systems involved and is at your side with the implementation accordingly.
System Selection
A neutral view from the outside can be helpful so that a new computer system fits the business process that it is supposed to support and so that it can be easily integrated into the existing system landscape. In addition, it should be checked in advance whether the computer system and the associated supplier(s) are suitable for meeting regulatory requirements (e.g. CSV, audit trails).
Periodic Reviews
Periodic reviews of the resulting documentation, which is intended to maintain the validated state of the computer system, can detect and correct errors and derive opportunities for optimization. . A review by a machCon expert who is outside your own organization can be useful.
IT System Retirements
The replacement and decommissioning of an IT system is usually underestimated. In addition to the termination of licenses, it is also about backing up the data that is stored in this system. These 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 old system. The deletion must take into account the classification of the data.
Our customers
Novartis Pharma AG
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
Roche Pharma Research IT
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
Sandoz International GmbH
Highly skilled 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 & socialized smoothly with the whole team.
Head of Laboratory IT
Contact person
Contact us for
more information
Alena Brandenburg
Principal Consultant Quality Management
alena.brandenburg@machcon.com
