LAKEWOOD, CO November 20, 2009
/24-7PressRelease/ -- Reglera, LLC recently announced that the Reglera Electronic Donor Eligibility Software (DES) System now has the capability to manage embryos intended for donation and gestational carriers in two new process workflow modules. These new modules, released in October of 2009 in conjunction with an upgrade of the (DES) software (Version 3.0.0), will serve as comprehensive workflow management tools to guide reproductive tissue establishments through the necessary process flow to optimize efficiencies in the donation of embryos and management of gestational carriers. Clients report an increase in processing efficiencies of more than 100% when using the new modules.
The Embryo Donation Workflow Module and Gestational Carrier Workflow Module are new to Reglera's pre-existing Electronic DES System, a one-of-a-kind outsourced turn key solution for reproductive tissue establishments that provides a complete workflow management process for documenting and determining Donor Eligibility. The system was originally introduced in 2006, and three years later in 2009 there is still nothing else like it on the market. The system's workflow management process has been proven to significantly reduce internal operating costs by streamlining the Donor Eligibility Determination process and therefore saving valuable man hours. It is currently the only Part 11 validated electronic system for determining the eligibility of donors of HCT/Ps and comes with the knowledge and support of Reglera's seasoned regulatory and quality tissue experts. It is web-based and secure; allowing support for decentralized or centralized establishment locations and requires no upfront capital costs. The DES workflow process effectively guides establishments through the administration of Custom Donor Applications, Custom Questionnaires and Genetic Screening Tests, as well as the required FDA compliant Screening Questionnaires, Physical Exams, Infectious Disease Testing and final Eligibility Determination by a responsible individual.
Embryo Donation Workflow Module
Reglera's new Embryo Donation Workflow Module will primarily address situations where sexually intimate partners (SIPs) who were not originally screened and tested at the time of embryo cryopreservation later wish to make a directed or anonymous donation of their embryos. The Module can optimize embryo donation in these situations by providing specific support including exemption qualification, complete process flow management, and documentation of all activities performed. The module will ultimately help to ensure that appropriate measures as required by the regulations are completed by establishments to determine if an embryo is available for donation before transfer while documenting the entire process correctly.
Gestational Carrier Workflow Module
Reglera's Gestational Carrier Workflow is a customizable, user-friendly software module designed to fit with IVF clinics' pre-existing processes for managing gestational carriers. Though not currently required by the regulations, many reproductive clinics have always performed the same screening and testing on gestational carriers that they have on donors of reproductive tissue in an effort to protect all parties involved in the IVF process. Reglera's Gestational Carrier Workflow Module now allows these clinics to track information on gestational carriers in the same convenient, secure, online location they track donor information. The module offers increased peace of mind for IVF clinics in knowing that they are going above and beyond the current regulations for reproductive tissue establishments. Clients report an increase in processing efficiencies of more than 100% when using the new Gestational module.
About Reglera, LLC
Reglera provides regulatory and quality assurance consulting and outsourcing services to both the medical device and human cellular tissue industries. Whether you need assistance with the FDA or are simply trying to comply with the myriad of regulations and standards, Reglera's products and services will accelerate your success and profitability. Reglera has many years of experience in the Reproductive Tissue Banking industry, with expertise that comes not only from setting up compliant regulatory and quality systems but also from practical business experience.
For additional information about Reglera, contact Tim Anschutz at anschutzt@reglera.com or call 800.341.4255.
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- carriers, clinics, donation, donor, eligibility, embryo, embryos, fda, gestational, hct/ps, ivf, regulations, software, tissue
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