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FCS Express provides comprehensive 21 CFR Part 11 compliance features. FCS Express offers you the most complete set of compliance tools to meet the needs of your regulated life-science laboratory.
The Problem
FDA’s
Electronic Records and Electronic Signatures Rule (“Part 11”)
defines the requirements for submitting documentation to FDA in
electronic form as well as criteria for use of electronic
signatures. These regulations – which affect the creation,
maintenance, transmission, storage, modification, and submission of
electronic records -- have added new challenges to the regulated life
science industries. To verify conclusions you make from test data, FDA
wants to be able to use the same tools to evaluate data that you
did. The FDA also requires that you can account for every detail
as to how you arrived at your results. Key to such data evaluation and
manipulation is a means to control the metadata – the data that
software uses to render your data into meaningful reports.The Solution
FCS Express with CFR Part 11 Compliance. Designed to maintain both the machine-readable metadata and human-readable reports, FCS has the following features to enhance your Part 11 compliance program:- Security,
Access Limitations, and Authority Checks allows you to control
which functions people are allowed to perform on a user-based and layout-based level. Over 300
independent security permissions can be set for each security group,
giving you tremendous flexibility in defining your own access
limitations.
- Record Protection
prevents unauthorized manipulation of FCS Express metadata and
reports. Flow cytometry raw data can also be stored with metadata
and reports, facilitating protection and traceability.
- Audit Trails:
FCS Express employs secure, computer-generated, time-stamped audit
trails to track actions that create, modify, or delete FCS Express
layout files and reports.
- Electronic
Signatures: When users are satisfied with their flow cytometry
report, they can electronically sign it. Signing events are
maintained in the audit trail. Signed reports can be securely
transferred in a variety of formats to your laboratory information
management system.
- Much, much more: sophisticated encryption, print logging, print tagging, password aging and many other features serve to help you ensure that your flow cytometry analysis is in full compliance with Part 11 regulations.
- See what security features are in FCS Express 6.
In
today’s regulated environments, it is more important than ever to
ensure that your experiments meet the highest standards of
traceability, reproducibility and accuracy. FCS Express – now
with 21 CFR Part 11 Compliance Support – meets those needs.
Download your free evaluation copy today!
Download your free evaluation copy today!