Kapelan Bio-Imaging Announces the Release of the FDA 21 CFR Part 11 Compliance for its 1D Gel Analysis Software LabImage 1D.

The FDA 21 CFR Part 11 compliance plays a major role in regulated environments such as diagnostics and pharmaceutical companies. It defines a set of rules to make the digital analysis of data as secure and reliable as their non-digital counterparts. First defined in 1997 by the FDA (American Food and Drug Administration) this regulation forms the base for nearly every integration of computer based analysis within a GLP, GMP or GCP (GxP) environments.

Kapelan Bio-Imaging development of GxP compliance started early 2009. Since LabImage 1D is based on a fully integrated bio-imaging platform, the 21 CFR Part 11 relevant modules were integrated right into this platform providing a maximum of flexibility and use cases for the customer.
From now on each application can be delivered with 21 CFR Part 11 compliance. This will allow clients to work with different imaging applications within a single 21 CFR Part 11 compliant environment. Therefore, the need for configuration and system maintenance will drop to a minimum but also provide a unique user interface and secure IT environment for all Kapelan Bio-Imaging applications.
In the first step clients of LabImage 1D will now benefit from the easiest user interface in 21 CFR Part 11 compliant 1D software tools. Combined with the unique automation module even High Throughput Processes (HTP) can be setup for quality control or any other use case.
While the 21 CFR Part 11 integration requires maximum security and flexibility the Kapelan developer team designed an elegant and smooth way of integration. The regular 1D analysis does not require any external software tools. All the processing is done within the same software.
But not only is every day work easier in LabImage 1D. The user account management was designed for best customization and integration. So the central tool can be used to manage the whole administration. LabImage 1D can be used in network environments as well. This will allow workgroups to store analysis data within a central multi user database.

In summary the LabImage 1D 21 CFR Part 11 System provides:
- full integration of FDA 21 CFR Part 11 compliance (see compliance declaration)
- user authentication and authorization, password security
- printable Audit Trails, Approve/ unapprove process
- can be used with stand-alone database or network database (multi user access)
- seamless integration of Part 11 compliance – clients work within the same software
- minimum effort to setup and maintain system