OPUS BasePackage Validation

OPUS Base Package: Validation

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.

With OPUS, Bruker offers the answer to questions of data security, integrity and traceability.

Standard OPUS validation functions:

  • Extended user and password management
  • Access control, automatic system audit trails
  • Audit trail covers spectra, methods and software
  • Original data cannot be deleted or overwritten
  • All data (spectra, evaluation, reports) stored in a single file to guarantee data integrity and smart  archiving
  • Functions are integrated in OPUS. No additional software needed.