full issue - Association of Biotechnology and Pharmacy
full issue - Association of Biotechnology and Pharmacy
full issue - Association of Biotechnology and Pharmacy
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Current Trends in <strong>Biotechnology</strong> <strong>and</strong> <strong>Pharmacy</strong><br />
Vol. 5 (3) 1353-1361 July 2011, ISSN 0973-8916 (Print), 2230-7303 (Online)<br />
1360<br />
trial process. The CRO’s role under study in trial<br />
process is Contract Research <strong>and</strong> Testing<br />
Organization (CRTO) <strong>and</strong> site management.<br />
Each role has different service requirements<br />
which are met by various scientific applications<br />
that the organization has deployed at its data<br />
center. The major applications in the laboratory<br />
are described below.<br />
Laboratory Information Management System<br />
(LIMS) : LIMS is a <strong>full</strong>-featured client-server<br />
application on Micros<strong>of</strong>t Windows that meets all<br />
Good Laboratory Practices (GLP) requirements<br />
by providing <strong>full</strong> sample tracking, user<br />
certification, instrument management, st<strong>and</strong>ard<br />
<strong>and</strong> reagent management, <strong>full</strong> auditing, report<br />
<strong>and</strong> sample scheduling, on-line help, <strong>and</strong> many<br />
other functions. LIMS was designed to conform<br />
to the laboratories environment through<br />
configuration; not by custom programming.<br />
While most customers’ needs are met by <strong>of</strong>f the<br />
shelf LIMS product, there are times that<br />
extensions to the system are desirable. To meet<br />
these extensions, LIMS open architecture allows<br />
configuration changes <strong>and</strong> customization using<br />
basics (4).<br />
Empower: Empower 2 is Waters’ flagship<br />
chromatography data s<strong>of</strong>tware (CDS) package<br />
for advanced data acquisition, management,<br />
processing, reporting <strong>and</strong> distribution. Designed<br />
for a data-secured regulatory lab environment,<br />
Empower 2 will help labs to perform more<br />
efficiently <strong>and</strong> securely (4). It can help:<br />
• Store <strong>and</strong> retrieve chromatography data<br />
using an embedded, relational database.<br />
• Calculate more precise peak integrations<br />
with ApexTrack algorithm. .<br />
• Achieve more enhanced detection<br />
capabilities when using Waters mass<br />
detectors or the Waters Photodiode Array<br />
(PDA) detector<br />
• Grow seamlessly from a single workstation<br />
to an enterprise-wide system with Empower<br />
2’s scalable, modular architecture<br />
SDMS: SDMS is a Scientific Data Management<br />
System (SDMS) is used to create a common<br />
electronic repository for all types <strong>of</strong> scientific<br />
data in the lab environment. SDMS allows the<br />
scientist in the lab to focus on the core work by<br />
eliminating the burden <strong>of</strong> paper work. SDMS<br />
improves the value <strong>of</strong> information by enabling<br />
scientist to share <strong>and</strong> utilize the data generated<br />
from a range <strong>of</strong> laboratory applications. The<br />
workflow in SDMS ensures that the documents<br />
can be viewed by analysts, group leader, quality<br />
control (QC) <strong>and</strong> QA to review <strong>and</strong> approve on<br />
time. SDMS is used for Project Management <strong>and</strong><br />
storage <strong>and</strong> retrieval <strong>of</strong> instrumental <strong>and</strong> noninstrumental<br />
data with compliance to 21CFR<br />
Part11 <strong>of</strong> USFDA (4).<br />
Analysis: (Fig 4, Fig 5) are drawn using the data<br />
collected from two different implementations i.e.<br />
old <strong>and</strong> new database servers.<br />
The old database server is hosted on IBM<br />
AIX version 5.3. From figure 4, it is obvious<br />
Fig. 4. CPU <strong>and</strong> memory utilization <strong>of</strong> the old<br />
database server<br />
Chavali et al