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Integrative
Solutions LLC
18 Old Jacksonville Rd
Towaco, NJ 07082
USA
Tel: +1 973-299-0807
Web: http://www.integrativesolutions.net
Email: info@integrativesolutions.net
Contact: Robert Wis
Integrative Solutions LLC (IS) is a software product and service company
that specializes in the computer system needs of the Pharmaceutical and
Chemical industries. IS offers a number of products
and services including the Statistical Trending And Reporting System (STARS).
STARS is a
fully validated software package designed to meet the trending and reporting
needs of
the Pharmaceutical laboratory. It is an easy to use 21 CFR Part 11 compliant
application. It is a database application that can be easily configured
to work in any commercial database. STARS also leverages the power of
SAS to perform several key analyses such as ANOVA, ANCOVA, Linear Regression,
Statistical Process Control, Environmental Monitoring and Annual Product
Reviews.
STARS contains several modules, which can be purchased separately, that
perform the most common trending and reporting functions required within
Pharmaceutical laboratories. The four modules are: - Stability, Release/SPC,
Environmental Monitoring, and Annual Product Review.
Universal Data Interface
STARS is configured
with an easy to use LIMS import routine that connects to all ODBC-compliant
LIMS. All that is required is the addition of a View object within each
LIMS for the user identified stability data fields. STARS can retrieve
data from multiple LIMS environments within one project.
STARS is designed to accept stability data directly from the LIMS but
it can also accept stability data from a CSV-formatted text file, EXCEL
file, MS-ACCESS database or SAS dataset.
Data Editing Features
STARS provides
an easy to use Graphical User Interface that allows users to edit data
in a spreadsheet like grid. The most common editing features are available
such as Find/Replace, Cut, Copy, Paste, etc. STARS also provides an integrated
calculated column feature which allows users to create Excel-like formula
columns.
Statistical/Graphical Analysis
STARS utilizes the powerful SAS statistical analysis software to easily
perform the complex calculation required during stability data analysis.
Standard calculations include:
* Analysis of Variance
* Linear Regression
* Weighted Regression
* Scatter Plots
* Residual Plots
* Identification of Potential Outliers
In addition, STARS offers an ad hoc SAS procedure window that allows users
to write and submit their own customized SAS programs. These ad hoc requests
are fully audit trailed.
Ad hoc Report Generator
STARS is configured with an Ad hoc Reporting Tool that allows users to
create their own custom reports. Users can select fields for reporting,
identify sort and group by options as well as a SQL-like selection language
for sub setting datasets. Users can save reports as templates that can
be shared
between other users and projects. Reports can be created in either RTF
(Microsoft Word Document), html or PDF format. STARS generates man graphical
plots to aid in the statistical analysis process. These plots are created
as either PNG or ActiveX files.
21 CFR Part 11 Compliance
STARS has been designed and tested using GAMP guidelines. The Quality
Assurance Program at Integrative Solutions specifies the production of
Validation Master and Project Plans, Configuration Management, and Change
Control. Functional Requirement and Design Specifications have been
issued for STARS. Controlled System Test Specifications have been executed
and Summary documents have been issued which detail the testing results.
Validation protocols may be audited by appointment. STARS includes functionality
to meet 21 CFR Part 11 specificaitons as they relate to "Closed"
systems. STARS has multiple levels of security including password expiry.
Each user can have different security rights. The full audit trail includes
references to the date and time of the change, the user who made the change,
the type of change made and a description of the change.
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