Qualification & Validation

We carry out validation activities according to your wishes

We create protocols & test plans

The requirements for execution and documentation of validation of processes and IT/software in the Medical Device industry are being tightened in these years through increased compliance and authority requirements. AL Engineering has many years of experience with validation of processes and IT/software within the Medical Device industry in Denmark as well as abroad.

Environmental monitoring

By ensuring a good environment in production, a good delivery of high-quality products is ensured. Our experience with controlled environment and cleanroom validation extends from very small cleanrooms with a single sluice, to large complex facilities of several thousand m2 with class B, C, D and CNC, UDF solutions for class A areas above machines, and sluices with PLC interlock systems for separating the different classes, including the iso equivalents. Our specialists have more than 20 years of experience with environmental monitoring and validation of cleanrooms.

Risk analysis ISO 14971

The Medical Device industry is regulated by ever-increasing compliance/authority requirements. The increasing requirements aim to strengthen patient safety and to ensure sufficient availability of medical devices, which i.a. is based on a risk-based approach. The goal is that patients are better protected in all respects. We can offer help in managing risk management for medical equipment. We have a detailed knowledge of the analysis techniques FMEA/FMECA and HAZOP and have extensive experience with planning and implementation using the mentioned techniques as well as reporting risk analyses.

Process validation

AL Engineering can help define the right validation strategy and ensure implementation and execution. Regardless of whether it is large installations, new equipment or rehabilitation, we can assist with the task. As a starting point, we work in accordance with the IMDRF guideline for process validation.

Plant and equipment validation

AL Engineering can offer to tailor templates based on best practice from the industry. We can also carry out validation activities according to your quality system (QMS) and wishes. Including design of documents such as validation plan, URS, DS, FAT/SAT, RTM, IQ, OQ, PQ, Protocols/test plans and reports.

Do not hesitate to contact us to hear more