The criteria covered in 21 CFR Part 11 are not the only requirements that should be considered for compliant document management associated with clinical trials.
Whether using paper, shared drive or vendor-provided systems to manage regulatory documents, research organizations need to ensure their data is safe in the event of a natural disaster.
Learn how an eRegulatory-CTMS integration can improve workflows and bring additional benefits to your institutional research operations.
Expert webinar presenters answer attendee questions about 21 CFR Part 11 compliance and the validation process for electronic systems.
Watch this webinar to hear our expert presenters provide an overview of 21 CFR Part 11 and discuss the roles both organizations and vendors play during the validation process.
Forte’s development approach is to not only navigate industry regulations, but to strategize how to best serve and assist our community. Learn Forte’s philosophy towards developing 21 CFR Part 11 compliant systems.
Centralized monitoring can help monitors quickly identify problem protocols and/or sites to reduce regulatory risks, data errors and protocol deviations.
Learn how a Master Delegation of Authority can streamline the delegation process by standardizing tasks at the organization level.