System validation in life sciences

Faster time-to-market thanks to optimal qualification and validation

For companies in the Life Sciences sector, it is crucial to get a new product to market as quickly as possible. The development of a new drug takes about fifteen years on average, while the protection of drugs by patents ‘only’ lasts twenty years. So, the faster your market introduction, the more revenue you can achieve from the innovation.

Ordina provides a full qualification and validation service

To bring a medical product to market quickly and in conformity with current quality standards, you need proper system validation. This requires specialist knowledge, which is often lacking in Life Sciences companies. The vast amount of hardware, software and procedures usually involved make it almost impossible for the companies’ own people to maintain this. In addition, there is a high risk of damage to the company as a result of employee incompetence. With the Ordina Solution for System Validation, we take care of this whole process. In other words, with our approach, we ensure that all of the infrastructure, equipment, hardware, software, procedures and employees involved are and continue to be GxP compliant.

The Ordina Solution for System Validation in Life Sciences offers the following benefits:

  • Faster go-to-market: longer period of time to earn from your products, make money from your patent(s) and build/develop your market position.
  • Reduced costs: thanks to a specific approach and ready-made templates.
  • Compliant: you meet the current statutory and regulatory requirements at all times.
  • Continuity guaranteed: we provide specialists, a continuous approach and management.
  • Better chance of licence approval: the result of our approach and efforts.

Client case study– Nelson Labs Europe now works in a more effective and compliant way

Every product that comes into contact with drugs has to be tested for the presence of chemical substances. Nelson Labs Europe is the market leader in the research into these kinds of substances. This research is done in highly regulated environments. All computer systems and software have to be validated and the data generated by these systems has to be stored correctly. With a team of developers and compliance specialists, Ordina built a user-friendly application to easily store and present the analysis results in reports. In addition, we ensured timely validation and implementation of the software. Read more about this case study here.

Thanks to the Regulated Development approach, specific regulatory and quality requirements were already taken into consideration right from the start of the development process.

Our approach

With the Ordina Solution for System Validation, we provide a full qualification and validation service that covers all the needs of Life Sciences companies. We ensure that both IT systems and laboratory and production equipment are and continue to be compliant. In other words: that your equipment works how it is supposed to work, that everything is correctly documented and that your people are fully trained in its use. Our 150-plus specialists have up-to-date knowledge and experience in all knowledge areas. They adopt a specific approach with accelerators to make off-the-shelf products compliant more quickly.

Our approach consists of three steps: 1. analysis & gap assessment, 2. the drawing up of a remediation or transition plan and 3. go-live.

The result

  1. With more than 150 experts, we can always draw on the right knowledge, experience and expertise to carry out any type of qualification or validation quickly. Experts who also have experience of the life sciences sector.
  2. With our own approach, ready-made templates and specific training, we are able to ensure a more efficient validation process, faster implementation of the system and shorter time-to-market. This includes accelerators on SAP, RPA and Custom Development, among others.
  3. With our service model, we can take care of our clients’ validation and qualification needs. We provide the following services:
    – Making a complete system landscape compliant for a go-to-market (programme management and execution)
    – Management of and ensuring your system landscape continues to be compliant (outsourcing activity)
    – Continuous availability of the right knowledge and people at the right time instead of self-sourcing and training of a team in constant flux
    – Transparent reporting according to agreed SLAs
  4. Ordina has a broad service palette: if other competencies are required, we have the option to scale up knowledge-wise in related areas, such as cybersecurity and data science.
  5. We carry out validation of both hardware and software.