QuickFlow LIMS
Laboratory Information
Management System
Quickflow eSheet
Calculation Sheet
Quickflow QMS
Quality Management
System
Quickflow DMS
Document Management
System
Quickflow - Scientific Raw data management from Standalone Instruments.
Optimize scientific workflows with seamless integration of standalone instruments, utilizing RS232 or ethernet connectivity for enhanced data flow, ensuring efficient synergy, and precision in your processes.
- Overview
- Challenges
- Features
- Key Benefits
Overview
Effectively handling data from standalone instruments that operate independently of computer systems, such as Balances, pH meters etc., poses a significant challenge within the pharmaceutical industry.
Webosphere has introduced Genius Lab, a specialized system designed for the management and monitoring of scientific data originating from standalone instruments that operate independently from PCs.
Effortlessly enhance your data acquisition process by seamlessly integrating with standalone instrument systems such as balances, pH meters, dissolution equipment, and more. This direct integration, facilitated through RS232 or Ethernet connectivity, not only ensures a smooth flow of data but also optimizes the synergy between your instruments, fostering efficiency and precision in your scientific workflows.
The software aligns with the rigorous USFDA 21 CFR Part-11 guidelines and other essential regulatory standards. This guarantees the utmost levels of safety, regulatory adherence, and impeccable data integrity, ensuring a seamless and compliant scientific workflow.
Industry Challenges
⦿ Limited PC Connectivity:
➮Standalone instruments in the pharmaceutical industry, such as pH meters, analytical balances, and polarimeters, often lack the capability for PC connectivity.
➮The absence of PC connectivity means that data generated by these instruments cannot be easily saved as a soft copy, hindering efficient data management practices.
⦿ Data Backup Concerns:
➮The inability to connect to a computer raises concerns about data backup for the generated information.
➮Without a digital backup, there is a risk of data loss, which can lead to non-compliance with regulatory requirements that mandate the preservation and accessibility of critical data.
⦿ Feasibility Challenges for Backup:
➮Backup procedures from standalone instruments are often not feasible, making it challenging to implement data backup strategies.
➮This lack of feasibility complicates compliance efforts, especially in industries where data integrity is paramount, and regulations require robust backup mechanisms.
⦿ Compliance Issues with Regulatory Guidelines:
➮Regulatory guidelines may necessitate instruments to have backup capabilities, but some older standalone instruments may not be equipped with such features.
➮In some cases, these instruments may not even be connected to printers, making them non-compliant for use in Good Manufacturing Practice (GMP) laboratories where adherence to strict guidelines is essential.
⦿ Financial Burden of Acquiring New Instruments:
➮Acquiring new instruments with enhanced connectivity features is often costly for pharmaceutical industries.
➮The financial burden of investing in updated equipment poses challenges for companies, particularly for smaller enterprises with limited resources.
⦿ Audit Trail Absence:
➮Standalone instruments typically lack an audit trail facility, which is crucial for tracking and documenting any changes or actions related to data.
➮The absence of an audit trail poses a significant limitation as it hampers data integrity and traceability, both of which are critical in regulated industries like pharmaceuticals.
Features
⦿ User can enter the details of the Product such as Product Name, Batch No, AR.No, in the template before performing the activity and this details appears on the print along with the activity details performed on the instrument.
⦿ User details are mentioned on the print through which one can identify the person who has performed the activity by looking at the print. (For example, from the instruments like Balances, pH meter, Moisture analyzer if the print is taken from the instrument user details will not appear on the print)
⦿ The software allows multiple standalone instruments to connect to a single PC.
⦿ Compliance with 21 CFR Part 11 and GxP requirements is met by the system.
⦿ Compatibility with instruments having RS 232 ports is ensured.
⦿ Old instruments with RS 232 ports can be connected, resulting in cost savings.
⦿ Data generated is backed up regularly.
⦿ Electronic signatures are supported for authentication purposes.
⦿ Different access levels (Analyst, Reviewer, Manager) are available for users.
⦿ Previous batches' data can be accessed and reviewed at any time.
⦿ Being web-based, the application can be accessed from anywhere with an internet connection.
Key Benefits
⦿ Instrument Connectivity:
Genius Lab Software facilitates the seamless connection of multiple standalone instruments to a single PC, overcoming the limitation of individual instruments lacking PC connectivity.
⦿ Centralized Data Storage:
The software enables the convenient storage of generated data on a server, allowing for centralized and organized data storage for easy access when needed.
⦿ Data Backup Functionality:
Genius Lab Software provides easy-to-use data backup functionality, addressing concerns about data loss and aligning with regulatory requirements for robust data backup procedures.
⦿ Compatibility with Older Instruments:
Even older instruments with RS 232 ports, which may not have modern connectivity features, can be connected to the software, ensuring data storage on the server and facilitating printouts for documentation.
⦿ Financial Savings:
The software eliminates the need for organizations to invest in new instruments, reducing the financial burden associated with acquiring updated equipment with enhanced connectivity features.
⦿ Convenient Access to Data:
Centralized storage on the server ensures convenient access to data whenever needed, streamlining workflows and enhancing overall operational efficiency.
⦿ Enhanced Data Security:
By storing data on a server, Genius Lab Software contributes to enhanced data security, protecting critical information from risks associated with standalone instrument limitations.
⦿ Facilitated Printouts:
The software's connectivity features enable the generation of printouts even for older instruments, ensuring compliance with documentation requirements and facilitating record-keeping.
⦿ Seamless Integration:
Genius Lab Software seamlessly integrates with a variety of instruments, creating a unified and connected laboratory environment for improved data management.
⦿ User-Friendly Interface:
The software is designed with a user-friendly interface, making it accessible and adaptable for laboratory staff, regardless of their technical expertise.
⦿ Audit Trail Capabilities:
One of the standout features is the inclusion of audit trail capabilities, ensuring that every action and modification to data is documented, maintaining data integrity and traceability.
⦿ Regulatory Compliance Assurance:
Genius Lab Software's features collectively contribute to regulatory compliance by addressing data storage, backup, and connectivity requirements, ensuring that laboratories adhere to industry standards and guidelines.
