Testimonials

As a closet-case developer, I think I couldn’t have designed the product any better.  We chose the product because it was a clear leader among the others.  It is truly a great product and designed with the user in mind (simplicity to achieve business processes). 

rapiddeploy "white glove" service

Avoid starting from scratch for many standard business use cases.

Generis and its partners have implemented CARA for many different common business use cases. Through a combination of our experience on these projects, and input from regulatory or other business requirements, we have developed a simple process to deploy our pre-configured RapidDeploy packages, along with a White Glove service to help you with the selection and management of external partners.

Visit our Data Sheets page to download information on the different packages available.

A.
Analyze.
The initial step is to analyze with you how closely the RapidDeploy configuration meets your requirements, and what gaps / additional configurations you may need.
B.
Build.
We update the configuration to add company-specific requirements such as particular workflows, data lists and any user interface "branding" - or you can do this yourselves.
C.
Cover end-to-end.
We deliver the RapidDeploy configuration, and help you install. We also guide you or your selected implementation partner through the process to ensure smooth handover.

Quality Standards

Generis develops its software to the rigorous Quality Standards that many of our clients require.

Our Quality Management system is based on ISO 12207, and follows the validation methodology. We are qualited audited by customers several times a year.

The packages

1
Quality / SOP
Management of SOPs and other quality documentation including full lifecycles, automated periodic reviews, and building sets of related documents.
2
Change Control
Often linked to the Quality / SOP package, this contains the elements necessary to create and manage the Change Request process and associated documents.
3
Regulatory Affairs / Submissions
This package covers the core requirements of submissions, including CTD - but goes well beyond to add submission planning/tracking and registration tracking.
4
eTMF
The full specification of the DIA EDM Reference model is delivered with this package, including Investigator/site access via the CARA Portal to upload documents.
5
Contracts Management
The range of functionality required for managing contract creation (from templates) through detailed review and document comparison to approval and watermarking with eSignature.
6
Human Resources
No other platform or product allows such easy deployment of tight security (down to masking sensitive metadata, and watermarking documents) required for HR.
7
Government
This package comes with the CARA Portal that allows for easy upload of documents as well as anonymous viewing of public documents through the web.
8
Legal
This package implements the tight security required, along with legal hold for discovery. Also included are document comparison, redaction and creating case packages