Process validation of an ERP system in a regulated environment: What you need to know.

From production errors and quality defects to penalties due to regulatory compliance issues: Without a validated ERP system, companies in the pharmaceutical and medical device industries face significant risks.

Validating an ERP system is key to ensuring safety and transparency, as it guarantees that workflows meet all requirements. However, achieving a validated ERP system poses challenges for many companies.

The approach to the subject, the allocation of internal resources, and the development of an efficient and sustainable validation framework within the company are significant hurdles that must be overcome.

Specifically, for companies in regulated environments, Yaveon offers an industry-specific ERP solution along with proven validation consulting and targeted project methodologies that enable secure and efficient validations, even in the public cloud. In highly regulated industries, the focus is not just on efficiency but on product safety, compliance, and the reputation of your business.

Computer system validation leaves nothing to chance. Every step of the process is meticulously checked to ensure your ERP system operates securely as intended. Only in this way can you consistently produce high-quality products with precisely the same composition.

Industry expertise from the professional: validation consulting

An experienced partner understands regulatory requirements and industry-specific standards inside and out. Whether in a GxP-regulated environment, medical devices, or pharmaceutical technology, the experts at Yaveon understand your challenges. Our proven validation consulting provides you with the necessary expertise.

Reduced validation effort and faster results with best practices

With preconfigured validation templates, comprehensive documentation, and best practice guides, you can accelerate the process and benefit from proven approaches like the V-model. Less effort, more focus on what's essential: your innovations.

Robust support and training

A strong partner trains your team and supports you throughout the project, ensuring not only that your software is fully validated but also that your team is optimally prepared. The path to validation is the path to sustainable success and creates the space to develop new ideas.

Suitable industry-specific ERP solution based on Microsoft from Yaveon

Companies in the process manufacturing industry will find in our industry-specific solution an ERP for regulated environments. Based on Microsoft Dynamics 365 Business Central, one of the most popular ERP systems for small and medium-sized enterprises, it covers all crucial work areas and provides full transparency.

• Supplier relationship management with the Vendor Scorecard App
• Batch management with the Lot Management App
• Production management with the Manufacturing App
• Quality controls with the Quality Assurance App
• And much more

Initial validation

The initial validation takes place during the implementation of the ERP system. It involves checking whether the system aligns with the company's specific processes and regulatory requirements. The entire validation must be documented in a traceable manner to the initial version.

Revalidation

Any change to a validated computer system must be controlled and thoroughly documented through change control. This is referred to as system revalidation. Examples include software updates and the introduction of new functionalities.

To make system revalidation as straightforward as possible, companies should implement a validation framework. This framework is a standardized approach for system updates that should be established company-wide. It is especially crucial in the SaaS environment, where fixed update schedules by the provider must be strictly adhered to. Such a framework enables timely and efficient revalidation.

The validation framework can be envisioned as a well-thought-out toolkit with a blueprint. Trained company staff can rely on it as needed and execute the necessary steps for revalidation effortlessly.

Validation typically follows a structured approach based on proven models like GAMP 5, using the well-established V-Model. The process essentially includes the following steps:

1. Validation planning

This phase involves developing a comprehensive strategy for validation, covering all necessary tests and documentation. The planning phase lays the foundation for a successful implementation.

2. Risk analysis

Risk management is a crucial part of validation. Potential risks are identified, analyzed, and evaluated to ensure the system is safe and compliant. The focus of the validation itself is on the high-risk areas.

3. Execution (installation, operational, and performance qualification)

• Installation Qualification (IQ): Verification that the software and hardware are installed correctly and meet technical requirements. With the rise of SaaS systems, this aspect is becoming less significant as infrastructure and system provision are handled by the service provider.
• Operational Qualification (OQ): Ensuring the system's functions meet specified requirements. This is particularly relevant for software not developed to GAMP standards or custom developments programmed for clients. For Yaveon apps, this step can usually be skipped for standard functionalities.
• Performance Qualification (PQ): Verification that the system operates as intended in the actual work environment. This is also known as process testing, aiming to ensure that business process flows function safely with the aid of computer systems. It is considered the core of validation.

4. Validation report

The process concludes with a validation report that summarizes and documents the results of all tests and checks. This report is crucial not only for internal purposes but also as evidence for regulatory authorities.

Having a validated ERP software offers more than just compliance.  

• Regulatory security: Companies avoid fines and regulatory issues.  
• Seamlessly efficient processes: Validated systems ensure all work processes run smoothly and reliably.  
• Confidence in products and top quality: Validation enhances trust in a company's processes and products.  
• Flexibility and future-proofing: A validated ERP system makes future developments and adjustments easier to achieve.  

Software validation is not an obstacle in regulated environments; it's an opportunity. With the right strategy and an experienced partner, you can navigate the process securely, efficiently, and effortlessly. In the pharmaceutical and medical device industries, reliable ERP validation is the foundation for long-term success and future-proofing. The perfect foundation: our industry-specific ERP solution combined with expert validation consulting.