Vibrational Spectroscopy Software OPUS

OPUS Validation

The OPUS VALIDATION package considers all prerequisites to operate FT-IR, -NIR and Raman spectrometers compliant to current Pharmaceutical regulations.

OPUS Validation

Features

More than spectroscopy software. OPUS offers a holistic approach to cover the manifold aspects of compliance to Pharmaceutical regulations.

For GMP and good practices in general, OPUS is the only infrared and Raman spectroscopic software that provides complete 21 CFR part 11 compliance.

OPUS Validation Program (OVP) was developed to help pharmaceutical manufacturers and other regulated companies comply with GMP/GLP/cGMP requirements in the most cost effective manner.

Automated performance testing according to Pharmacopoeia requirements (i.e. USP, Ph. Eur.)
Qualified for cGMP use
21 CFR Part 11 compliant electronic records and signature management
Fulfills latest FDA guidance on Data Integrity
State-of-the-art user management following the concept of segregation of duties (SOD)
Comprehensive Audit Trails
System Validation Manual to support and document the qualification process

Cutting-edge hardware deserves best in class software. Bruker’s mission statement is easily interpreted to “Innovation with Data Intengrity”, which perfectly fits to the all-new concept of OPUS 8 offering 365 degrees of compliance. Electronic records rigorously follow the ALCOA+ principle, are captured in automatic Audit Trails and the Protected Data Pool safeguards these from deletion and manipulation. The sophisticated user and signature management supports different user levels to enforce segregation of duties (SOD) and supports every password requirements with respect to expiration, complexity, re-use and many more.

The OPUS Validation Program OVP supports automated and transparent OQ & PQ performance test procedures for continues control of the instrument performance according to Pharmacopoeia requirements (i.e. USP and Ph. Eur.), supported by certified reference materials.

The comprehensive system validation manual, considering all aspects of computer system and spectrometer qualification such as DQ, IQ OQ and PQ supported with test and training log forms, completes the care free validation package. Of course all required certificates and compliance statements are included as well.