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Tecnosoft TS Manager Software for 21 CFR Compliance

  • Part #:TS0165
  • Availability:AVAILABLE
Price: $1,512.00
Price: $2,041.20

Description

The software meets all requirements of FDA 21 CFR Part 11, GAMP5, Annex 11 regulations and presents some peculiar features meeting some requirements of particular applications. It is dedicated to process and instrument, particularly autoclaves, validation.

Features:

  • Data in the devices not editable
  • Data in software not editable and encryptable
  • Access for each user through login and password
  • Client/server setup and shared database
  • Multi-user access
  • Multi-level users, with different functions for each one
  • Customers and validated Instruments database for validators activity
  • Logbook: recording, not editable, of all carried out operations
  • Data analysis through pre-set or customizable parameters
  • Possibility of pre and post mission comments
  • Visualization in graph, with zoom, and table
  • Multi graph analysis
  • Graph divided into Sections with analysis and statistics for each section
  • Synchronized data table with statistics for each acquisition: maximum, minimum, average, maximum-minimum, maximum-average, average-minimum
  • Theoretical temperature calculation based on pressure in saturated steam environment
  • Print of customizable reports
  • Data and reports export in HTML and XLS (MS Excel) format

Specifications:

Operating systems: 
Windows 10, 11 (32, 64 bit)
Regulation compatibility: 
FDA 21 CFR Part 11
Data loggers supported: 
SterilDisk, P-Micro, S-Micro, S-Disk J, MicroW, L-Disk, RHTemp, PressureDisk, S-Radio, Pirani acuum Logger, TempStick, HumiStick
Data management: 
Client/server database with single missions, groups, customers, instruments, devices, programming profiles
Data display: 
Graph (with zoom) and table (exportable into Excel and HTML), markers for process start and end, printed report of all the data, Multi graph
Customizable parameters: 
Acquisition step, mission duration, analysis type (lethality with Z and reference temperature values setting, Overkilling for validation)
Calculated parameters: 
Lethality (F0, PU. A0 etc.)
Accessories: 
DiskInterface HS (Part #: TS0200), Universal Multibay (Part #: TS04MBU) , TecnoStick Interface (Part #: TS04IUSB)
Languages: 
Italian, English, German