Compliance Documentation Consulting, Systems Comsulting
We can help turn your company around.
  1. Document Simplification and Complexity Reduction
  2. Documentation Authoring Software
We Are:
  • well versed in the current Code of Federal Regulations (CFR), as it applies to the Life Sciences industry.
  • experienced in working with the requirements for other business compliance standards such as ISO 9001:2000, ISO 13485, ISO 14001 and TS16949.
  • Simplify complex documentation systems
  • Improve ‘right first time’ quality
  • Harmonization/standardization among sites
  • Reduce time-to-market and product release cycle times
  • Reduce R&D document development time
  • Reduce cycle time for product transfer to commercial production
  • Simplify implementation of paperless manufacturing system
  • Prepare data/documents for migration to EDMS
  • Reduce deviations and investigations
  • Technical translation from English to Spanish