GxP Regulations Compliance

Companies that operate in regulated environments such as the pharmaceutical, medical device, food and cosmetic industry face the challenge of increasing regulatory scrutiny and the risk of non-compliance. TMSWeb is a comprehensive solution for automating GxP (GMP, GLP, and GCP) processes and maintaining compliance with regulatory agencies. 
TMSWeb provides:
  • Streamlined Workflows (manage processes from implementation to finish)
  • Audit Trails & Reports (efficiently prepare for inspections and execute audits)
  • Controlled Documents (essential documents readily available and accessible via permissions)
  • Good Documentation Practices (ensures accuracy, completeness, consistency and reliability)
  • Employee Training (certifies responsible workforce is trained and qualified with defined roles)
  • Change Control (data revisions with traceability and review/approval signatures)
  • Electronic Signatures (captures date and time stamp and adheres to 21 CFR Part 11)