Intellisync Interface Inprocess Check System is a data integrity system comprising software and hardware. Software is installed on a server and shall be accessible to respected clients. The software consists of a master database and it can generate reports. Hardware is installed close to the Instrument and is used for converting the output from the Instrument into software in the computer via LAN.
The test Instrument transfers the values to the system via an interface. The measured values are compared with pre-defined tolerance limits fed in master data. Master data can be maintained for multiple parameters for all stages of the product. Visual display indicators of the sample being out of tolerance limit, help the user to take corrective action and The reports are generated digitally.
Intellisync Interface Inprocess Check System is a combination of software and hardware to perform QC tests for tablets/capsules and generate a report for the QC test.
Web application (Software) is implemented on the server, authorized users can log in to the system.
Intellisync Interface mainly includes instruments and HMI As hardware in our system.
HMI (interface) can be set up in The cubicle or near the instrument. It is connected to The instrument with an RS-232 communication port for data transferring between HMI and the instrument.
The other HMI (Interface) Is Also Attached To the software Via The LAN connection for data transferring between the HMI And the Software.
Intellisync Interface can be used via local server by all users in the same network. Thus, it eliminates human error.
First, product setup is done on The web application, with The cubicle and area set up with Equipment, Instruments, and products and assigned Batch No. and start the process.
Once The process starts, The user will log on to The activated interface and verify all parameters Displayed On The screen such as in-process Test product, Batch No., and Other details.
After That, the user selects any parameter selects The rotary side enters the sample size (No. of sample to be tested), And starts to perform the in-process test for The selected parameter on The particular instrument that performs.
Once all the tests have been completed, the tested value is compared with the pre-defined tolerance limit (Help The user take corrective action) message will display a report within or out of The limit.
Based on the performed test, The reports are authentic and customized, as The time-stamp and No. of printed copy can be verified.
All the data is permanently stored.
All the reports shall be electronically generated and printed reports can be verified manually by signing the documents.
The Audit Trails feature is also available, an authenticated user can check step-by-step records of all activities. It is used to verify and track The history of each critical event.
In The software, The instrument logs can also be viewed by selecting The instrument type and Instrument ID by an authenticated user.
The application supports the 21 CFR PART 11 Guideline.
Intellisync Interface has a single application with multi-point in-process testing using different instruments. with the same functionality, the system supports 21 CFR part 11 compliance.
– Prevent cross-contamination of the product.
– Controlled man and material movement.
– Enhance the productivity.
Cross-contamination is a critical concern in pharmaceutical industries as it can compromise product safety and efficacy. To mitigate this risk, it is essential to control the movement of both personnel and materials within the production facility. This control can be effectively managed through the Intellisync Interface, which oversees in-process checks for tablets and capsules, ensuring that these tests are performed within their designated areas.
Hardware – 7-inch Touch Screen HMI with RS-232 and RS-485 COM Ports supported.
Software – Django-Based Web Application, Python Version 3.10
Supported OS – Windows/Ubuntu
We provide efficient after-sales support, ensuring that clients receive timely assistance when needed, which adds to your product’s building long-term relationships with our clients.
Intellisync Interface Inprocess Check System guarantees data integrity Through authenticated and time-stamped reports generated digitally and all the data are permanently stored.
The System’s ability to support multi-point in-process testing using different instruments from a single application adds value by streamlining processes and reducing complexity for users.
Web-based applications are stored in the same network, which eliminates human error, and HMI. The product offers a user-friendly interface that enhances usability and accessibility for operators.
Ensuring adherence to regulatory standards 21 CFR part 11 compliance. Maintaining high-quality standards is important to ensure compliance and meet regulatory requirements.
Despite its advanced features and capabilities, your product remains competitively priced, offering value for money to your customers. This balance of quality and affordability sets your product apart in the market.
Q. What is the Intellisync Interface Inprocess Check System?
The Intellisync Interface Inprocess Check System is a comprehensive data integrity system consisting of both software and hardware components. It facilitates quality control tests for tablets/capsules in pharmaceutical industries and generates detailed reports.
Q. How does the system ensure data integrity?
The system ensures data integrity through authenticated and time-stamped reports generated digitally. All data are securely stored, and reports can be electronically verified and manually signed for further authentication if needed.
Q. What are the key features of the hardware?
The hardware includes a 7-inch touchscreen HMI with RS-232 and RS-485 COM ports supported. This interface connects with instruments for data transfer and facilitates user interaction during the testing process.
Q. Can multiple users access the system simultaneously?
Yes, the Intellisync Interface Inprocess Check System can be accessed via a local server by multiple users within the same network. This feature helps in eliminating human errors and streamlining processes.
Q. Is the system compliant with regulatory standards?
Yes, the system supports 21 CFR part 11 compliance features and is developed following GAMP 5 guidelines, ensuring adherence to regulatory standards in pharmaceutical industries.
Q. How does the system handle multi-point testing?
The system supports multi-point in-process testing using different instruments from a single application. Users can perform tests for various parameters simultaneously, enhancing efficiency and productivity.
Q. What kind of after-sales support is provided?
We offer efficient after-sales support on an India basis, ensuring timely assistance and troubleshooting for our clients. This support adds to the overall value proposition of our product.
Q. What operating systems are supported by the software?
The software is based on Django and supports Python version 3.10. It is compatible with Windows and Ubuntu operating systems, providing flexibility in deployment across different platforms.
Q. Can the system be customized for specific user requirements?
Yes, the system can be customized to meet specific user requirements. From setting up equipment and instruments to assigning batch numbers, users have the flexibility to tailor the system according to their needs.
Q. How are reports generated and managed?
Reports are generated digitally with customizable formats and are date and time-stamped for authentication. These reports can be securely stored on the server and electronically verified, with the option for manual verification if necessary.