logo

Select Sidearea

Populate the sidearea with useful widgets. It’s simple to add images, categories, latest post, social media icon links, tag clouds, and more.
hello@youremail.com
+1234567890
 

EDITLife and FACT

EDITLife Software for Cell Therapy
3 Compliance Challenges
Solved with EDITLife Software for Cell Therapy

Getting the Full Picture

Tracking and gathering data to prove compliance with FACT Standards for each process can be very time consuming.

The Challenge of Complexity

Program growth (more patients, new therapies, etc.) means more data. A lack of data organization leaves staff struggling.

Frequent Changes

Staying aware of – and reacting to – new requirements or changes and updates to the existing requirements can be exhausting.

Simplify compliance with FACT and other regulatory standards...

... with EDITLife talent and technology!

Designed in collaboration with Physicians, Clinicians, and Data Coordinators
who understand the frustrations around regulatory compliance,
EDITLife software for Cell Therapy helps centers comply with standards.

The EDITLife Solution

One centralized database captures data during all phases (including Diagnosis, Evaluation, Selection, Matching, Collection, Transportation, Processing, Storage, Conditioning, Infusion, and Disease Status) to document adherence to FACT/CIBMTR (as well as FDA, AABB, and other) standards

Quick and easy access to data needed for written documentation and on-site inspections

User-friendly report building tools help you prepare interim/annual/follow-up reports.

all people

Quality and Compliance

EDITLife makes it simpler to stay ahead of a constantly changing and complex regulatory environment. Compliance issues are addressed on an ongoing basis, minimizing last minute scrambling and enhancing program Quality.

 

A single platform, EDITLife seamlessly connects clinical, regulatory, and quality data to allow for proactive planning and a rapid, accurate response to audits.

The solution supports compliance with hundreds of FACT standards, including:

Clinical Program Standards

Collection Facility Standards

Processing Facility Standards

FACT

TOOLS THAT SUPPORT FACT STANDARDS

EDITLife features that support FACT compliance include:

Conditioning Regimen

Donor Selection

Product Collection and Processing

Protocol Management

Inventory

Reporting Tools

And so many more. Below are just a few examples.

EDITLife Cell Therapy

Conditioning Regimen

A roadmap of the selected regimen keeps  everyone informed of to-do and completed steps.

EDITLife automatically updates the regimen summary as each step is completed. Documented summary data includes Total Radiation, Total Conditioning Medication, and Total GVHD Prophylaxis Medication.

FACT Standards
FACT Standards

Donor Selection

EDITLife’s Donor Selection tool displays data captured throughout the application, including Evaluation data, for comparing recipients with any number of related/unrelated donors or cord units.

The tool uses the center’s criteria to highlight mismatches on risk factors, including Demographics, Vitals, ABO, CMV, and HLA Tissue Typing, to help clinicians select the most appropriate donor, and identifies donors for high-resolution HLA testing.

Product Collection and Processing

The Collection screen provides a Collection Summary (including Cell Counts).  A Process Summary is provided for each Collection. Raw and Absolute Cell Counts are displayed, including Nucleated WBC.

Data related to Bag Treatment, Bag Contamination, Bag Disposition, and Product Manipulation Prior to Infusion is presented.

FACT Standards
EDITLife for Cell Therapy
- Support for FACT Standards -
Whether you do 10 infusions a year or 200, EDITLife provides tools to help you maintain compliance with FACT (and other) regulatory standards.
See the EDITLife Difference