CSV - quality assurance for critical IT systems

We can determine the applicable legal and normative requirements for IT systems and processes and plan, test and document the subsequent review using officially reliable methods. Our experience, existing process landscape, templates and tools enable us to carry out professional and legal processing with outstanding efficiency.

Support at all levels:

  • Audit und analysis of the current state
  • Requirements engineering
  • Design and planning
  • Development, testing and coordination
  • Go-Live
  • Operation and maintenance of the valid state

IT quality service portfolio

  • Our teams ensure that validated computer systems are introduced and maintained entirely in accordance to your requirements. This means putting the system through its paces and integrating it into your company. This includes complete documentation, risk-based test strategies and interaction with other systems and, of course, trained end users. Ideally, we use professional application lifecycle management systems to ensure experienced introduction and operation.

  • It is not uncommon for a valid operation to be criminally neglected following the successful introduction of a new system. This ultimately leads to non-compliance. In order to nip this in the bud, we guarantee continued valid operation according to a risk-based approach within your processes. From requirements and change, test and training management within your life cycle management to the planned and orderly decommissioning and archiving of a system.

  • MS Excel as the most popular platform for the quickest use of complex options for evaluating accumulating data, even in regulated areas, harbors unimagined dangers through incorrect use and, in most cases, inadequate knowledge of the user. We are familiar with Excel and all the pitfalls in use within regulated processes. This means we can not only validate it, but can also check whether it can be validated and then make this possible.

  • Benefit from our strengths as a specialist in the field of software testing and the relevant regulatory requirements. Our certified test managers create an optimal test strategy for your applications, but are also happy to take over the complete organization and handling of test and validation activities using a tailored tester team to achieve the required compliance of your solution. This gives you planning security and the quality you need.

  • In us, you have a partner you can rely on for the testing of complex and change-intensive systems, who offers you higher quality and cheaper support by using suitable test automation solutions. Integrated and managed in your ALM system and compiled specifically for your needs. Don't leave bugs to chance or to the intuition of a tester in the future!

  • Our wide range of services in the regulated environment makes us experienced specialists at all levels of quality management. We are happy to evaluate your current situation and advise you on how to optimize your quality management system according to your requirements and your legal requirements. This is always with the aim of an efficient and custom-fit system that enables your processes to run smoothly, ensuring you trouble-free compliance.

  • In particular, lateral entrants in a regulated industry usually need experienced specialists from practice who can establish their current situation and compare and evaluate them against the specific target situation. Our experienced auditors can provide support – no matter the level of necessity and experience of our customers. Be it through mock audits, supplier audits, gap analyses or continuous periodic reviews to check the compliance of systems and processes.

  • Due to our many years of experience in software validation and development, we are all too aware of the importance of requirements engineering. It not only prevents planned IT projects from failing, but also significantly reduces the number of errors, especially serious design errors, the correction of which can lead to massive additional costs. That is why we recommend that our certified requirements engineers are on-board to provide customer support as early as possible in the requirements phase. This reduces costs, while increasing the quality, which is why it is indispensable!

  • The introduction of large internationally used systems can quickly pose a challenge to the project, not only technically, but also in terms of role and location-specific training. We can organize the various training units for you, design documents and carry out training remotely or face-to-face in order to be able to guarantee a smooth go-live.

  • Thoroughly tested software is worthless without a continuously maintained and qualified IT infrastructure. For this reason and to ensure valid IT systems and software, we support our customers in qualifying their IT infrastructure from acquisition and operation to final decommissioning and documentation.

  • Since EXCO employs specialists in all areas in regulated processes in companies, we can realize complete systems, processes and plants for production according to your needs. For example, we can provide requirements engineering, software for custom programming, unit tests, functional tests, documentation, coordination, project management and end user training from a single source! Perhaps you’d be interested in a final acceptance test from your end users in order to prove your decision correct.

Process knowledge

  • V-Modell XT
  • Scrum / Agile
  • GAMP 5
  • CAPA – Corrective & Preventive Action
  • FMEA
  • IT Infrastructure Library
  • Requirements Engineering
  • IT Project Management
  • ISTQB Certified Tester

Highest standards

  • US FDA 21 CFR Part 11 ERES
  • US FDA 21 CFR Part 820 QSR
  • US FDA 21 CFR Part 210 cGMP
  • US FDA 21 CFR Part 211 cGMP
  • EU GMP Vol. 4 Annex 11 & Annex 15
  • PCI DSS Security Standards
  • ISO 13485 Medical Devices QMS
  • ISO 9001 QMS
  • ICH GCP E6
  • ZLG Aide mémoire

Project Reference

Validation UDI

EXCO is assigned to validate and test a Unique Device Indentification (UDI) database.

Project Reference

Validation as a Service

A customer needs a continuous CSV service to keep their computerized systems valid in the long term.

Project Reference

Medical App

EXCO supports the development of a CGM device by delivering software that uses wireless communication.