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.

MEDAGENT VALIGUARD

Keeping Your Validations Up-to-Date and Compliant

In the dynamic world of medical technologies and software, it is crucial that your validation processes not only comply with current standards, but are also continuously monitored and adapted. That’s why we are pleased to introduce our new periodic monitoring service. With this service, MEDAGENT ensures that your validations always comply with the latest regulatory requirements and that your processes and software are continuously optimized.

CONTINUOUS MONITORING:

Our team of experts carries out regular reviews of your existing validations to ensure that they always comply with current legal and industry standards. This includes a detailed analysis of the performance of your systems and processes to identify potential deviations at an early stage.

PROACTIVE CONSULTING:

In addition to monitoring, we offer proactive consulting to identify potential risks and optimization opportunities. Our aim is to make your systems not only compliant, but also efficient and future-proof.

ADVANTAGES

Ensuring that your validations always comply with legal requirements. This includes continuous review and adaptation to new regulatory standards and guidelines. We ensure that your processes and products are compliant with international and local regulations at all times, minimize the risk of compliance violations and strengthen the trust of your customers and partners.

Reduce the workload for internal resources by taking over monitoring and coordination tasks. Our service relieves your teams by taking over the continuous monitoring of your validation processes. This allows your specialists to focus on their core competencies and innovative work while we take care of regulatory compliance. Our specialized tools and processes increase efficiency and reduce the time spent on routine checks.

Avoiding operational disruptions through early detection and resolution of problems. Our approach to proactive risk minimization includes regular audits and analysis to identify potential problems before they can lead to operational disruptions. By implementing corrective actions and preventative strategies, we improve the overall reliability of your processes and systems, resulting in higher product quality and customer satisfaction.

Ensuring that your processes and software keep pace with the latest technologies and best practices. We offer not only monitoring of your current systems, but also advice and support in implementing new technologies and methods. By keeping you informed of industry trends and innovative solutions, we help you to future-proof your processes. This includes the introduction of automation, the use of data analytics and the application of agile methods in product development and validation to secure competitive advantages and strengthen your market position.

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Would you like to learn more about how our periodic monitoring service can support your validation processes? Contact us today for an individual consultation and find out how MEDAGENT can meet your compliance requirements efficiently and reliably.

At MEDAGENT, we pride ourselves on offering our customers high-quality solutions that not only meet today’s requirements, but also master future challenges. Our periodic monitoring service is a further step in our efforts to ensure the quality and security of your medical technologies and software.

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