Regulations

“Good Manufacturing Practice” GMP and “Good Laboratory Practice” GLP . are the guidelines recommended  for manufacturing and distributing  pharmaceutical products, drug products, food and cosmetic products.

GMP guidelines comprise the use of computers in the production environment or in the laboratories:

  • Computers used must have an audit trail to document all activities and changes
  • Documentation must be protected against alteration
  • Input to and output from the computer or related systems shall be limited to authorized personnel only

SmartAuditTrail reduces time and efforts for validation!