Freya Wolles Business Development Manager Q +32 496 77 45 14

Lab Equipment Qualification

GUARANTEE THE QUALITY OF YOUR WORKING METHOD AND RESULT

Laboratories must comply with a lot of quality requirements and laws. Analytical Instrument Qualification (AIQ) is a must to obtain reliable, accurate and consistent results, whether or not associated with Computer System Validation (CSV) and method validation.

Ordina helps you meet these strict quality requirements and supports you in applying the various rules and regulations, including FDA, ICH, EMEA, Pharmacopeia, GLP (Good Laboratory Practices) guidelines and ISO standards.

Concept

Ordina assists you in applying Analytical Instrument Qualification and method validation. This includes all the steps in the process, including instrument categorization and qualification according to the four 4 Qs (DQ, IQ, OQ and PQ), and method validation according to cGM and GLP regulations and regulatory guidelines (FDA, EMEA).

Approach

Our experts guide you in qualifying and validating various instruments and methods. In this process we adopt a risk-based approach, based on years of experience and our knowledge database. You can also rely on Ordina for the detailed drafting of the necessary documents, protocols and procedures.

Result

With Ordina you can rest assured that you will comply with the relevant and latest legislation and requirements. These reliable, reproducible, complete and correct testing and working methods allow you to guarantee the quality of your product and patient safety at all times.

Lab Equipment Qualification Contact Contact Freya Wolles