Process, software & method validation

Are your processes, software and methods already demonstrably validated, but need a thorough update? Or is validation a book with seven seals for you? – Get in touch with our team, we are your partner.

Our experts work with you to develop efficient validation strategies for your systems, always with the aim of ensuring the safety and functionality of your medical devices. We help you with the implementation, planning, control and classification of your processes that require validation or qualification. Our services range from the creation of suitable procedures, work instructions and forms to the definition of customer-specific and normative acceptance criteria. Furthermore, we are happy to support you in all implementation activities, such as the determination of a defined sample size and communication with Notified Bodies or testing laboratories.

Process validation

Within the scope of process validation, we support you in proving that the production processes for your medical devices and thus your manufacturing processes have been safely developed and will work reliably over the entire duration of the product life cycle. If your quality control does not completely cover all potential risks, process validation must be used to ensure that the purpose of the product is fulfilled in practice. The basis for this is the so-called V-model.

We help you to meet the requirements of the relevant standards and to provide the required proof with a high degree of safety by checking your process together with you, taking into account the worst-case conditions in the process. Always with the aim of ensuring a robust and reliable process within the defined scope of application.

How does Process validation work?

1. Identification  and analysis

First of all, together with your management and your production department, we identify and analyze the current processes and document them accordingly. Once we have established the initial situation in your company, we begin to develop a validation strategy by analyzing the dominant factors, such as time and material. Together we define rules for the processes that comply with international norms and standards. – Good planning forms the basis for a successful future.

2. planning

Together with the technical experts from the production or manufacturing and quality departments of your company, we will draw up a solution-optimized validation plan that is tailored to your specific requirements and then implement it together with you. Our validation team uses its many years of practical experience to apply the formal processes exactly where they have a positive effect on quality. Let our experts advise you!

Software validation

“The IT infrastructure is being qualified meanwhile the software application is being validated”.

As an external expert, we work with your quality management team and your IT department to validate the effectiveness of your internal software systems and tools as part of a software validation. The focus is always on the effects of the software on the respective medical device, or the associated service that influences the quality of the medical device or the medical device itself.

Our experts test softwares that you use for the quality-relevant production of your medical device. In addition, they also validate the application of the software you use as part of your overall quality management system. Our professionals also check the software that is contained in the (usually active) medical device itself.

Here, too, we work together with the technical experts in your company to draw up a validation plan in compliance with specific specifications and using statistical methods, which is then implemented. Together, we define rules for the processes that comply with the current edition of the DIN EN ISO 13485 standard, GAMP5 and MDR.

Our aim is to help you to implement these requirements in your company in a practical, effective and efficient manner. In this sense, software validation for us means to provide you with documented evidence to confirm that your systems meet the mentioned requirements.

Method validAtion

Method validation is required when non-standard methods are used in quality control. This includes, for example, the validation of measuring systems and test equipment that have an influence on the medical device.

On the basis of two studies (Gauge R&R Method 1 and Method 2) we check the capability of your measurement system or test equipment.