PMID- 21973024
OWN - NLM
STAT- MEDLINE
DCOM- 20120423
LR  - 20180629
IS  - 1477-2566 (Electronic)
IS  - 1465-3249 (Linking)
VI  - 14
IP  - 1
DP  - 2012 Jan
TI  - Implementation of a configurable laboratory information management system for use 
      in cellular process development and manufacturing.
PG  - 114-21
LID - 10.3109/14653249.2011.619007 [doi]
AB  - BACKGROUND AIMS: Regulatory requirements for the manufacturing of cell products 
      for clinical investigation require a significant level of record-keeping, 
      starting early in process development and continuing through to the execution and 
      requisite follow-up of patients on clinical trials. Central to record-keeping is 
      the management of documentation related to patients, raw materials, processes, 
      assays and facilities. METHODS: To support these requirements, we evaluated 
      several laboratory information management systems (LIMS), including their cost, 
      flexibility, regulatory compliance, ongoing programming requirements and ability 
      to integrate with laboratory equipment. After selecting a system, we performed a 
      pilot study to develop a user-configurable LIMS for our laboratory in support of 
      our pre-clinical and clinical cell-production activities. We report here on the 
      design and utilization of this system to manage accrual with a healthy 
      blood-donor protocol, as well as manufacturing operations for the production of a 
      master cell bank and several patient-specific stem cell products. RESULTS: The 
      system was used successfully to manage blood donor eligibility, recruiting, 
      appointments, billing and serology, and to provide annual accrual reports. 
      Quality management reporting features of the system were used to capture, report 
      and investigate process and equipment deviations that occurred during the 
      production of a master cell bank and patient products. CONCLUSIONS: Overall the 
      system has served to support the compliance requirements of process development 
      and phase I/II clinical trial activities for our laboratory and can be easily 
      modified to meet the needs of similar laboratories.
FAU - Russom, Diana
AU  - Russom D
AD  - Department of Information Technology Systems, City of Hope, Duarte, California 
      91010, USA.
FAU - Ahmed, Amira
AU  - Ahmed A
FAU - Gonzalez, Nancy
AU  - Gonzalez N
FAU - Alvarnas, Joseph
AU  - Alvarnas J
FAU - DiGiusto, David
AU  - DiGiusto D
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20111006
PL  - England
TA  - Cytotherapy
JT  - Cytotherapy
JID - 100895309
SB  - IM
MH  - Blood Donors/statistics & numerical data
MH  - *Cell Transplantation
MH  - *Clinical Laboratory Information Systems/economics/legislation & jurisprudence
MH  - Eligibility Determination
MH  - Follow-Up Studies
MH  - Humans
MH  - Pilot Projects
MH  - Practice Guidelines as Topic
MH  - Software/*economics/*trends
EDAT- 2011/10/07 06:00
MHDA- 2012/04/24 06:00
CRDT- 2011/10/07 06:00
PHST- 2011/10/07 06:00 [entrez]
PHST- 2011/10/07 06:00 [pubmed]
PHST- 2012/04/24 06:00 [medline]
AID - S1465-3249(12)70620-5 [pii]
AID - 10.3109/14653249.2011.619007 [doi]
PST - ppublish
SO  - Cytotherapy. 2012 Jan;14(1):114-21. doi: 10.3109/14653249.2011.619007. Epub 2011 
      Oct 6.