Qualification package provides a set of tools used to achieve compliance with the US FDA's cGMP and GLP regulations, as well as other government or industry regulations
Thermo Electron announces the launch of the new ValPro system qualification package for laboratory FT-IR instruments, sampling accessories and Raman spectrometers.
This qualification package provides a set of tools used to achieve compliance with the US FDA's cGMP and GLP regulations, as well as other government or industry regulations.
The ValPro package for laboratory spectrometers includes procedures to qualify the full range of FT-IR, NIR and Raman spectrometers, and sampling accessories.
Targeted at drug development and manufacturing customers, as well as other highly regulated industries that require proof of good instrument operation, the package represents a significant increase in efficiency for training and maintenance.
The move allows customers to qualify their FT-IR spectrometer - including ATR and diffuse reflectance sampling accessories - as a complete system using traceable standard reference materials, and offers Raman platform users unprecedented levels of validation.
In addition, ValPro offers methodology compliant with European, British and Japanese Pharmacopoeias.
ValPro's extensive documentation stands up to regulatory audits with detailed information and procedures that address the Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ) aspects of system qualification.
A wide range of traceable standards for manual or automated operation is available and detailed instrument qualification documents are provided.
Thermo also offers a full range of qualification services, enabling customers to deploy solutions with complete confidence that they will comply with regulatory requirements.
