SOP Management - Standard Operating Procedure Management

Learn How Standard Operating Procedure ( SOP ) Management is a Compliance Tool for FDA GMP, GLP, GCP, and ISO Environments

Standard operating procedures management is commonly used across all industries to help companies operate safely and more efficiently. Properly managing SOPs for manufacturing companies that are ISO or QS/TS certified is mandatory. Within pharmaceutical, medical device, biotechnology, or other industries regulated by the FDA, SOPs must be managed with strict change control processes to assure proper compliance with current good clinical practices (cGCP), good manufacturing practices, (cGMP) and good laboratory practices (cGLP). Whether or not an industry imposes specific requirements, SOP management is to be done in a controlled manner and should be implemented as a standard business practice.

Ressources disponibles

Sélectionnez toutes les ressources que vous souhaitez télécharger.

Standard Operating Procedure Management and Document Control Software Facts

  • MasterControl Documents has been successfully implemented, validated and inspected in FDA environments without any instances of non-compliance since its introduction in 1998
  • A SOP management system dramatically reduces the time it takes to bring a new product to market by speeding up the process for document change, approval, notification, and distribution
  • Une solution personnalisable et prête à l'emploi, conçue pour une installation, une implémentation et une validation rapides
  • Garantit l'intégrité de la documentation de sorte que les employés disposent toujours des versions les plus à jour à portée de main

Core Capabilities of Standard Operating Procedure Management

  • Combine des processus performants de routage et d'approbation électroniques
  • Full audit trail and reporting is available for good sop management
  • Gestion et contrôle des signatures électroniques
  • Conformité à la partie 11 du titre 21 du CFR, et sécurité et intégrité des documents garanties
  • Plan de validation des systèmes informatiques et mise en œuvre, notamment :
  • Validation-ready for IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Process Qualification)
  • Architecture ouverte et évolutive des systèmes
  • Compatibilité avec les bases de données standard du secteur

Sustain Regulatory Compliance with MasterControl's Standard Operating Procedure Management Software

It is possible to move away from outdated, unconnected, inefficient standard operating procedure management practices. The electronic standard operating procedure software solutions are part of MasterControl's content management suite. The suite includes easy-to-use, fully integrated applications that can be configured to meet the unique needs of small, mid-size, and large companies. These applications include the following:

  • Documents MasterControl
  • MasterControl CAPA
  • Formations MasterControl
  • MasterControl Forms
  • MasterControl Change Control
  • MasterControl SOP Management Audit
  • MasterControl Customer Complaints
  • MasterControl Non conformité
  • Passerelle d'envoi MasterControl

MasterControl's suite helps companies establish compliant standard operating procedure management system so they are always ready for inspections and audits.