SOP Management System

Standard Operating Procedures (SOPs) are commonly used across all industries to help companies operate safely and more efficiently.

Within the pharmaceutical, medical device, biotechnology or other industry(s) regulated by the US 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).

The development and use of SOPs minimizes variation(s) and promotes quality through consistent implementation of a process or procedure within the organization, even if there are temporary or permanent personnel changes.

Ultimately, the benefits of a valid SOP include reduced work effort, along with improved comparability, credibility and legal defensibility.

KnowledgeNET provides an accretion of managing all the documents of SOP. It provides an archive of all the documents regarding different departments of a particular SOP. It is especially helpful if SOP drafts are actually reviewed by individuals other than the original writer/author before the SOPs are finalized. KnowledgeNET provides the facility for managing the review and approval process efficiently. The lifecycle of SOP documents is managed with ease by keeping track of the users creating, reviewing and approving the SOP documents. It also provides version controlling for each and every SOP, managing all effective dates, due dates and any other important dates. It manages a version history which allows for the ability to retrieve any historical information regarding past versions. It also ensures that the latest version is the one currently in use. It also provides reporting module to keep track and identify, at any time, where in the life cycle an SOP is and who is currently responsible for it at that moment.

Salient Features:

• Snapshot view of all SOPs' tracking
• Facility of publishing SOPs
• Reminders for schedules and delays
• Document commenting
• Decreases in cycle time and the associated costs by increasing efficiencies