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Contact 3C:

Address:
20 Commerce Drive
Suite 125
Cranford, NJ 07016

Telephone:
(908) 272-4787

Fax:
(908) 272-4631

E-Mail:
Solutions@3CPharma.com

 

 

Clinical

As a heavily regulated industry, Compliance is an ongoing priority for pharma. Systems and business processes need to comply to government regulations, and pharma staff need to comply with SOPs. 3C Company can help ensure your compliance with years of experience in validation & remediation of systems as well as developing new systems to monitor ongoing staff compliance with SOPs.

21 CFR Part 11 Validation

Validation & Remediation for compliance of a legacy Clinical Trial Management System deployed worldwide

 PROJECT SUMMARY
   

Compliance Tracking

In a regulated environment, SOP compliance is always an issue, and this large pharmaceutical company was no exception. It had recently come to light that study monitors were experiencing difficulty in producing approved site visit reports in a timeframe and with the frequency called for by the Standard Operating Procedures. 3C Company was challenged with developing a system for scheduling investigative site visits, and tracking the subsequent draft and approval of trip reports. This system works closely in concert with the CTMS to minimize any additional steps for the study monitor. Today the internal compliance team uses the data in this system to ensure a uniform high level of quality and timeliness of the site visit reports.

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