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WICELL SERVICE
OPTIONS |
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Attributes |
non-cGMP Service |
cGMP Service |
|
Intended Use |
Recommended for Research
Product Characterization |
Recommended for Translational
and Clinical Product Characterization |
|
Use for research and development and to familiarize
your team with the service and results. |
Used to verify the quality of cellular
materials for inclusion in regulatory submissions. |
|
|
Compliant with 21 CFR
211 |
No |
Yes |
|
WiCell holds quality
as our top priority. Our quality system consists of a dedicated Quality
Assurance Team ensuring compliance, supplier management, and a robust
training program. |
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|
Personalized Customer
Technical Support |
Yes |
Yes |
|
Supplier
Qualification |
Yes |
Yes |
|
Harvest Reagent
Traceability |
Yes |
Yes |
|
Harvest Batch Record |
No |
Yes |
|
Quality
Questionnaire |
Yes |
Yes |
|
In-Person Audit |
No |
Yes |
|
Quality
Agreement |
No |
Yes |
|
Prospective Process
Description |
No |
Yes |
|
A process description
allows for work to be customized by cell type, project, and is pre-approved
by the client. |
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|
Method Qualification
Available |
No |
Yes |
|
American Society of
Clinical Pathology (ASCP) Certified Analyst |
No1 |
Yes |
|
1All WiCell karyotypes are analyzed by two
analysts (at least one of whom is ASCP certified) and QC reviewed by a third
analyst. |
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|
Deviations
Reported |
No |
Yes |
|
Publication Images |
Yes |
Yes |
|
Final Test Report |
Yes |
Yes |
|
All final karyotypes
are reviewed and signed by an American Board of Medical Genetics and Genomics
(ABMGG) board certified or board-eligible director. |
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|
Final Test Report with
QA Review |
No |
Yes |
|
Certificate of
Compliance |
No |
Yes |
|
Data Package
Available |
No |
Yes |
|
Custom Report Writing
Support Available |
No |
Yes |
