Organizations dedicated to the life sciences have the conflicting needs of ever shorter development cycles, while maintaining strict compliance to US and International regulations. The need for speed and efficiency is driven by competitive market demands; the failure to meet compliance standards can result in costly delays.
To avoid or minimize these risks, life sciences organizations should adopt new information management strategies to improve product quality, efficacy and safety. The clear and proven path is the electronic record and document content management system that allows an organization to manage the following:
SOPs (Standard Operating Procedures):
eCTD (Electronic Control Technical Documentation) submission for regulatory agencies:
CCP:
21 CFR Part 11:
21CFR Part 211:
SPL:
eCTD (Electronic Control Technical Documentation) Scanner:
ED&CMS (Electronic Document and Content Management System):
