TS MANAGER – SOFTWARE COMPLIANT WITH 21 CFR PART 11 AND GAMP
TS Manager – advanced software for operating temperature, humidity and pressure recorders
TS Manager is a software developed in accordance with the guidelines of 21 CFR Part 11 and GAMP (no possibility to change the stored data). It enables the collection, display and analysis of data from all loggers designed for operation in high temperatures, pressure and humidity. The software (with a hardware license key) works with the following Tecnosoft recorders:
SterilDisk (all versions),
PasteurDisk Can,
SterilDisk Can,
S-Disk J,
P-Micro (all versions),
S-Micro (all versions),
P-Radio,
S-Radio,
S-MicroW (all versions),
L-Disk,
RHTemp (all versions),
PressureDisk (all versions).
It has functions for validating the work of autoclaves with the reporting module. The intuitive interface allows you to easily create lists of customers and devices, profiles for validation and analysis of processes, as well as configure the recorders and download data from them. Additionally, we offer IQ / OQ qualification protocols.
Main features and functions
The user cannot interfere with the collected measurement data in the software.
No possibility of interfering with the data in the recorders.
Individual user accounts (login) secured with a password.
Possibility to create multiple user accounts and grant them permissions .
Architecture client / server .
Database of registrars and customers (for the convenience of companies validating devices).
Logged in the registry (without the possibility of editing) of all user actions.
Data analysis using configurable profiles.
Possibility to add comments before starting and after completing the measurement.
It allows you to configure, start measurements and read data from recorders.
Viewing and analyzing data in the form of tables.
Viewing data in the form of graphs with a zoom function.
Viewing data from many measurements (recorders) on one graph (including recorders of various types).
Synchronized viewing of data with statistics for multiple measurements carried out at the same time: maximum, minimum, average, maximum-minimum, maximum-average, average-minimum.
Analysis of selected fragments of charts .
Displaying the established limits for alarms on a graph.
Calculation of the theoretical value of the temperature based on the pressure in the saturated steam environment.
Configurable reports printing .
Export of data and reports in HTML and XLS (Excel) formats.
Parameters
The system cooperating with the TS Manager software consists of the following elements:
A compatible recorder.
DiskInterface HS Mini, DiskInterface HS or the multi-port Multibay interface.
Modular controllers Unistream PLC + HMI Unitronics company provide an economical solution for manufacturers , where required for the compliance with 21 cfr part 11 electronic signature.
K ompleksowe UniLogic environment for programming controllers Unistream, offers features that allow validation of the system in accordance with the provisions of 21 CFR Part 11, including:
Program version control and change history tracking
User access control and administration
Keeping records of configuration changes, operator actions and alarms
Data storage and export to generate audit trails
This document covers the Unitronics UniStream PLC + HMI control tools for developing 21 CFR Part 11 compliant applications .
Control of electronic data records and audit trail in UniLogic software
The UniLogic development environment has comprehensive tools to ensure compliance with the regulations on electronic data record control in accordance with 21 CFR Part 11. The UniLogic utility software enables the identification of changes in the UniStream program, including hardware configuration, PLC logic or HMI panel design . UniLogic automatically logs all design changes every time a new program is loaded into the UniStream driver ; the changed object is registered , type of change, time stamp and user identification (electronic signature). Recorded data is encrypted and saved in the project database. The data can then be displayed in a clear list allowing full traceability of changes to the project program.
You can restrict access to a programmed project so that only authorized users can make changes. Downloading a new program to the controller can also be limited to authorized users by assigning usernames and passwords to them. The code can be downloaded independently of the entire project, which increases the security of the application. To ensure full security, access to the computer on which the UniLogic application is installed must be controlled using passwords built into the operating system and encryption mechanisms.
HMI user administration and signing
According to FDA 21 CFR Part 11, access to the HMI should be restricted to users with appropriate permissions. To comply with this regulation, the program for the UniStream controller should implement multi-level access control. The username and password entered to access the system act as an electronic signature for the user or system operator. The username and passwords for different access rights can be predefined using the data table functionality to restrict certain system actions to specific users. Using data tables also allows the administrator to update passwords periodically to strengthen access control protection .
As the controller program is a proprietary password , it is not possible to access the PLC and HMI program without the supplied software and the correct password.
Likewise, the functionality of Trends may be used to track and record application data that may be transferred by legitimate users to other database systems for the purpose of data collection. Changes to the values recorded in these database files do not overwrite the previous values. Additionally, these files cannot be edited while stored in the UniStream driver .
It should be emphasized that after exporting electronic records related to applications from the UniStream ( UniLogic ) environment , they should be secured using a database application, operating system or other security mechanism.
Detailed instructions and advice on programming a 21 CFR Part 11 compliant application as well as UniLogic programming examples can be provided free of charge by Unitronics technical support specialists.