Pharmspec 3 Software User Manual
| | Definition | |---|---| | 21 CFR Part 11 | FDA regulation governing electronic records and electronic signatures | | ALCOA | Attributes for data integrity: Attributable, Legible, Contemporaneous, Original, Accurate | | Compendial Test | Standardized test procedure defined by an official pharmacopoeia | | EP | European Pharmacopoeia | | FDA | U.S. Food and Drug Administration | | HIAC | High-accuracy particle counter (brand of Beckman Coulter) | | HRLD | High Resolution Liquid-borne particle Detector | | IQ | Installation Qualification (validation of proper installation) | | IST | Instrument Suitability Test | | JP | Japanese Pharmacopoeia | | KP | Korean Pharmacopoeia | | Light Obscuration | Optical particle counting technology measuring light blockage by particles | | OQ | Operational Qualification (validation of operational performance) | | Parenteral | Administrable by injection, bypassing the digestive system | | Procedural Test | Test following compendial procedures with automatic Pass/Fail calculations | | Run Counter Test | Basic particle counting test without compendial calculations | | SOP | Standard Operating Procedure | | SVI | Small Volume Injectable | | LVI | Large Volume Injectable | | USP | United States Pharmacopeia |
Before using the system, you must configure it for your specific equipment:
The updated database engine (SQL Server 2017 for PharmSpec 3.5+) ensures continued Microsoft support through security updates.
6.1 Spectrum View & Manipulation 6.2 Peak Picking & Integration 6.3 Calibration Curves & Statistics 6.4 Pass/Fail Criteria Evaluation 6.5 Comparing Spectra 6.6 Manual Recalculation & Reintegration pharmspec 3 software user manual
To access PharmSpec 3, users must have a valid username and password. The software is web-based, and users can access it through a standard web browser.
PharmSpec 3 software has evolved across multiple versions to support modern computing environments. The latest release (PharmSpec 3.6) supports:
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For technical support, validation services, or to request a copy of the official PharmSpec User Manual, contact your local Beckman Coulter representative.
data integrity principles. This includes multi-level user rights, electronic signatures for review/approval workflows, and a secure, time-stamped audit trail for all actions. Compendial Testing:
Once a test completes, the software displays the raw data alongside a pass/fail indicator based on the selected compendial limits. To print a secure report, click > Print Secure PDF . The software is web-based, and users can access
The Specifications module allows users to manage and maintain specifications for pharmaceutical products.
Pharmspec 3 is the industry-standard software solution designed specifically for use with HIAC liquid particle counters. Whether you are performing routine USP testing or conducting complex research and development, understanding the Pharmspec 3 environment is critical for maintaining data integrity and regulatory compliance.
This alarm validates that the instrument configuration is suitable for use, checking:
Updated procedures for USP / , Ph. Eur. 2.9.19, and aligned standards for KP/JP.