SamplerSight Pharma Software
SamplerSight Pharmaソフトウェアは日本薬局 方(JP)、米国薬局方(USP)、欧州薬局方(EP)に定められた注射剤中の不溶性微粒子数を測定する、バッチサンプリングシステム APSS-2000で使用されるアプリケーションソフトウェアです。 電子記録・電子署名に関する規制である、21CFR Part 11に対応しています。 IQ/OQ/PQ文書などの検証マニュアルが用意されております。
This error occurs when the wrong Sensor Type is selected for your instrument when using SamplerSight Software. Using the Configure -> Instrument menu item, press the Configure button and ensure the Sensor Type matches your instrument.When starting SamplerSight or SamplerSight Pharma Software, select Sampler: Syringe as the instrument type for any Particle Measuring Systems serial-based syringe sampler.SamplerSight Pharma (SSP) stores the sample data in the Microsoft® SQL Server Database container. The database can either be installed on a local machine or networked with a remote SQL instance (the data will be then "somewhere" in the company network). The SQL Database is typically located under: C:Program FilesMicrosoftSQLServerMSSQL10_50.SQLEXPRESSMSSQLDATA when using the local machine data storage setup.Data retrieval is a dedicated functionality of the SamplerSight Software.
Data can be recalled or filtered using several “tags”. Examples of these tags include the date/time, or other specific information included in the sample report prior to sampling (batch number, lot, etc.)The SQL Express database (included in the software package) is limited to 10 GB of data storage, easily allowing use of the APSS-2000 for several years.
The “best” approach for one method may not be valid for all in terms of database usage. From a data integrity point of view, the SQL database does not have any risk of data loss due to quantity or age, provided
that a periodical backup is performed. One advantage of using a unique database is the capability to easily recall old data without changing the
database used. However, if recalling old data is not required, a yearly replacement database could be the desired solution.Sensors should be aligned during calibration at PMS. However, this may not be necessary if DC light and verifications and daily checks are within the specified tolerances.The instrument resolution is calculated by using the Electronic method, which is the most complicated method but most accurate in terms of results. Additional details about how the software performs the calculation can be given upon request.
