Services

Computer System Validation Services

We provide computer system validation services, including spreadsheet
validation/verification. Service options range from development of complete software
life cycle programs to simply writing and executing test scripts, in addition to 21 CFR
Part 11 Compliance program development.

Expertise lies in validation of Chromatography Data Systems (CDS), such as Sciex(R)
Analyst(TM), Perkin Elmer(R) Totalchrom, and Micromass(R) MassLynx.

An example of a complete validation project would include the following phases:

Validation Plan
User Requirements
Functional Requirements
Software IQ/OQ verification and/or execution
Test Protocol

Test Script Preparation
Test Script Execution
Test Protocol Summary

Final Report/Authorization

Software validation projects based on guidelines published in:

IEEE Std 1012-1998 Standard for Software Verification and Validation

References available upon request.

Custom Software Development Services

We provide custom software solutions, specializing in solutions for Scientific Analysis
Laboratory managers. We have in-depth knowledge of the needs, requirements, and
peculiarities of regulated and non-regulated data management. In addition, expertise is
held in the interaction of two popular laboratory data systems:

Sciex(R) Analyst(TM): The vendor makes available documentation that allows
developers the ability to utilize Analyst .dlls and their members to optimize the
way instrumental data is displayed. We have extensive experience writing
applications to take advantage of this.

Thermo Scientific Watson(R) is a Laboratory Information Management System
(LIMS) that is popular in laboratories involved in discovery, pre-clinical and
clinical studies. We have extensive experience writing applications that retrieve
data from the Watson database or archived .mdb files in order to display data in
a custom manner.

Spreadsheet Design and Validation Services

Spreadsheets such as Microsoft(R) Excel are still popular in some regulated
laboratories. The following services are provided:

Development of spreadsheet validation procedures
Execution of spreadsheet validation
Training for spreadsheet validation
Validated spreadsheet design