Pharma Focus

Overview LIMS Quickflow - LIMS IT Admin Analyst Webosphere LIMS presents a low-code, web-based software built on the Quick Flow platform. It efficiently manages Raw Materials (RM), In-Process, Intermediates, Finished Product (FP), and Stability samples, initiating from production (Test request), online software solution meticulously crafted for overseeing various standards employed within Quality Control laboratories across Pharmaceutical industries, Contract Research Organizations, Biotech companies, and GLP laboratories. It facilitates the comprehensive monitoring of primary and secondary standards utilized in Quality Control laboratories, spanning from their initial receipt and qualification through to their eventual disposal. Upheld by the highest safety and regulatory standards, it guarantees data integrity.

Our software boasts a user-friendly interface, enabling real-time tracking of sample status. It aligns seamlessly with USFDA 21 CFR Part-11, EU-Annexure-11 guidelines, and other regulatory norms.

Furthermore, our highly adaptable software can be customized to precisely match your Sample management requisites. Enjoy real-time visibility into your sample activities, enhancing your operational efficiency.
Reviewer Viewer Analyst User can create,
manage form, submit
form to reviewer, query builder dashboard etc. IT Admin Configure
user, operation, report,
department, product master, disable data etc. Reviewer User can review/
send back/submit the form, review audit trail, query builder etc. Viewer User can view/print pdf sheet, review form audit trail, query builder, analytical dashboard Challenges Quickflow - LIMS   &nbsp Manual test requests by the production team requires the sample information to be input manually and forwarded to the QC/QA department. This manual workflow entails increase in man-hours and decrease in efficiency.
  &nbsp The tracking of manual requests is not feasible. The test request sheets need to be indented well in advance from QA and this is a time-consuming process.
  &nbsp If accidentally, the chemist forgets to indent the test-request book, there will be delay in sample submission. This might in turn lead to deviation.
  &nbsp There are high chances of data-integrity issues during manual intervention. Analytical reference numbers (AR.No) are generated manually in the QC labs for which sample inward registers need to be maintained for every sample type. This results in a heightened workload.
  &nbsp The sampling-allotment is done manually by the QC/QA Analyst via excel sheets or work-allotment books. It is difficult to track the status of sampling on a real time basis.
  &nbsp The workload of the manager or in-charge also increases as they need to follow up the status of the sample analysis allotment and sampling allotment preventing seamless laboratory integration.
  &nbsp To track the sample status (i.e., pending/under analysis/under review/ approved), Inward registers need to be verified or excel sheets need to be maintained, there is a chance of missing the sample analyses which are of minimal priority in the manual sample allotment and this may impact the SLA.
  &nbsp The entry of test results in the test-report requires more effort and there are high chances of data integrity issues In Manual test report, there are chances of multiple strike-outs, which may lead to non-compliance.
  &nbsp To check any previously analyzed batch-results, analytical data to be archived from the QA, which requires more efforts and countless man hours. The chemist has to make sure that the trending analytical data is fetched from analytical reports and entered in the excel sheets which requires humongous effort.
  &nbsp The production team needs to follow up with the team QC for the release status of the sample, either by phone or by physically visiting the QC lab, which decreases the efficiency of the production chemists.
  &nbsp Mostly COA are prepared by taking the analytical results from the Analytical Test Report (ATR), which leads to recurring and redundant work.
  &nbsp There is no readily available history of prints taken in the manual COA preparation.
  &nbsp Maintaining multiple logbooks for working standards, reference standards, impurity standards, and reference solutions.
  &nbsp Risks of non-compliance and data integrity issues due to manual recording of entries in the standards usage logs.
  &nbsp Manual management and tracking of expiry dates for all standards, leading to decreased efficiency.
  &nbsp Increased likelihood of using expired standards for analysis due to difficulties in manually tracking expiry dates.
  &nbsp Challenges in managing Certificate of Analysis (COA) manually.
  &nbsp In a manual system, disseminating information and updates about standards to relevant stakeholders can be cumbersome. Lack of real-time collaboration can slow down the process of implementing changes.
  &nbsp Manual Standard Management systems often lack proper audit trails, making it difficult to track changes, identify who made them, and when they were made. This can cause problems during audits and can also raise security concerns.
  &nbsp Manual Standard Management systems may not adequately address compliance risks, leaving organizations vulnerable to non-compliance with industry standards and regulations.
  &nbsp Generating reports and analyzing data in a manual system can be slow and laborious. Organizations may miss out on valuable insights due to a lack of real-time data analysis.
  &nbsp Physical documents can be susceptible to loss, damage, or unauthorized access.

Features Quickflow - LIMS   &nbsp The software facilitates test request initiation by the production team for sample analysis.
  &nbsp Each sample is associated with a unique QR code, allowing easy retrieval of sample details through QR code scanning at any time.
  &nbsp The software generates a distinct Analytical Reference Number (AR.No) for each sample.
  &nbsp Comprehensive auditing capabilities ensure a fully audited trial for all actions performed within the software.
  &nbsp QC/QA can efficiently acknowledge samples directly through the software interface.
  &nbsp Sample allotment is seamlessly managed using the software's features.
  &nbsp The software provides multiple access levels based on designated roles and authorizations for enhanced security.
  &nbsp Different registration types (AR.No) can be utilized to distinguish between Raw Material (RM), In-process (IP), Finished Goods (FG), and Stability samples.
  &nbsp Analysts can easily access their assigned samples through personalized dashboards.
  &nbsp The software enables complete sample tracking from receipt to release, ensuring efficient workflow management.
  &nbsp Generation of release notes is automated within the software.
  &nbsp The Certificate of Analysis (COA) preparation is made effortless through software-generated COAs.
  &nbsp Department members can view sample statuses based on their respective designations and authorizations.
  &nbsp Print controls are readily available, streamlining document generation and management.
  &nbsp The software seamlessly supports the trending of analytical data, enabling in-depth analysis and data visualization.
  &nbsp Compliance with 21 CFR Part 11 and GxP standards.
  &nbsp Automatic generation of unique reference numbers for different types of standards.
  &nbsp QR code generation upon standard registration, facilitating easy tracking of standard details.
  &nbsp Time-saving usage entry through QR code scanning by analysts.
  &nbsp Multiple review levels for standard approval process.
  &nbsp Prevention of using expired standards as the system restricts entries for expired standards.
  &nbsp Generation of summarized reports by the system.
  &nbsp System-generated Certificate of Analysis (COA) for working standards.
  &nbsp Automatic updates and alerts through email notifications, issued at least 60 days in advance, for standard expiration and exhaustion.
  &nbsp Fully audited trial capability.
Benefits Quickflow - LIMS   &nbsp The software enables the production team to raise test requests seamlessly through pre-populated fields for In-process, Raw Material (RM), Semi-finished Goods (SFG), and Finished Goods (FG), eliminating the need for physical visits to QC/QA or manual test request books.
  &nbsp Real-time status tracking of test requests is facilitated, ensuring efficient monitoring of sample progress.
  &nbsp QA/QC can acknowledge samples directly within the software, streamlining the acknowledgement process.
  &nbsp The software automatically generates unique Analytical Reference Numbers (AR.No), eliminating the requirement for maintaining Inward registers and significantly improving efficiency.
  &nbsp Sampling-allotment and sample analysis allotment can be efficiently managed within the software, removing the need for manual sample allotment books and enabling real-time status tracking.
  &nbsp With a single click, the status of each sample can be easily tracked, simplifying sample management.
  &nbsp Long-pending samples can be identified promptly, enabling timely actions to be taken.
  &nbsp Digitalized test results can undergo multi-level review, facilitating error identification and rectification at the initial entry stage.
  &nbsp Instantaneous access to previous batch analysis results is provided through the Query-builder function.
  &nbsp Data retrieval from the software enables easy preparation of analytical "trends."
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Overview In the pharmaceutical industry, where adherence to stringent regulatory standards is paramount, Quickflow offers a comprehensive Electronic Logbook (eLogbook) solution that revolutionizes data recording and management. This web-based software serves as a versatile platform, capturing a wide spectrum of production, Quality, Warehouse, Engineering etc., activities, within a Good Manufacturing Practice (GMP) environment.

Quickflow Electronic Logbook Software ensures compliance with FDA regulations, notably 21 CFR Part 11, and aligns with other critical standards such as EU Annex 11, MHRA, GAMP, GMP, Standard Operating Procedures (SOPs), and ISO. The software is meticulously crafted to meet the stringent requirements set forth by major regulatory authorities, ensuring its efficacy in addressing the unique needs of pharmaceutical organizations.

Key functionalities encompassed by the Electronic Logbook Software span from tracking general production requirements to granulation, dispensing, stability schedules, and beyond. The platform facilitates the seamless transition from manual paper forms to electronic equivalents, enhancing accuracy, timeliness, and the overall efficiency of data entry processes. Approval workflows guarantee that entered details undergo validation, review, and authorization, reinforcing data integrity.

Despite the advent of digital technologies, pharmaceutical organizations still rely on logbooks as integral tools for quality assurance, regulatory compliance, and risk management. Logbooks offer tangible and auditable records, serving as primary evidence during audits, inspections, and legal disputes. QuickFlow's Electronic Logbook Software acknowledges the enduring relevance of logbooks and enriches their functionality by integrating them into a digital framework.

In the realm of equipment logbooks, QuickFlow's solution complies with FDA requirements, specifically addressing 21 CFR 211.182 Equipment cleaning and use log mandates. Equipment Log Management (ELOG) is identified as a crucial component of quality management systems. The E-LOG software, a web-based application, specializes in the meticulous documentation of equipment usage, cleaning, calibration, and related details within a GMP manufacturing environment.

Statistics affirm the significance of logbooks, indicating their widespread usage across the pharmaceutical industry. Their tangible nature provides a holistic perspective and serves as a primary source of evidence during regulatory inspections. Integrating digital technologies with logbooks optimizes accuracy, reliability, accessibility, and security of information, creating a synergy that enhances data management capabilities. Challenges   &nbsp High Risk of Compliance and Data Integrity Issues:
Human errors in manual data entry pose a significant risk to compliance and data integrity, potentially leading to regulatory non-compliance and compromised record accuracy. Resource unavailability or turnover may exacerbate this risk, as new personnel may not be adequately trained or familiar with existing logbook practices.

  &nbsp Real-time Request and Retrieval Challenges:
Real-time access to logbooks from Quality Assurance (QA) is difficult, impeding swift responses to information requests. The lack of instant access hampers decision-making processes and may impact timely interventions in case of quality or compliance concerns.

  &nbsp Management and Maintenance Challenges for Physical Logbooks:
Physical logbooks require meticulous management and maintenance, creating challenges in keeping an organized and up-to-date stock. The manual nature of these processes increases the likelihood of errors and inefficiencies in logbook tracking.

  &nbsp Tedious Yearly Logbook Changeover Process:
The process of changing all logbooks at the end of the year for the next year's usage is tedious and time-consuming. This annual changeover may result in disruptions, and manual efforts are prone to errors during the transition.

  &nbsp Difficulty in Simultaneous Issuing by QA Team:
Coordinating the simultaneous issuing of all logbooks by the QA team presents logistical challenges. This may result in delays and inconsistencies in the availability of logbooks across different departments.

  &nbsp Impractical Manual Recording of Extensive Information:
The manual recording of extensive information in logbooks, including product names, batch numbers, test/IPC numbers, and activity start times, is impractical and increases the risk of errors.
This manual process is time-consuming and may compromise the accuracy and completeness of recorded data.

  &nbsp Space Wastage Caused by Physical Logbooks:
Physical logbooks contribute to space wastage within facilities, requiring storage solutions that may not be efficient or cost-effective.
The physical footprint of logbooks can impact the utilization of workspace and storage areas.

  &nbsp Challenges in Protecting and Archiving Logbooks:
Protecting and archiving physical logbooks throughout their life cycle is challenging, especially with the risk of wear, tear, or damage.
Proper archiving practices are crucial for compliance and future reference, but they are often compromised in manual systems.

  &nbsp Difficulty in Retrieving Past Information:
Retrieving past information becomes challenging when logbooks are handed over to QA for archival. The lack of real-time access hinders the ability to quickly retrieve historical data, impacting decision-making and audit responsiveness.

  &nbsp Delay in Showing Information to Auditors:
Delays in accessing logbook details may occur, leading to delays in presenting information to auditors during inspections. This delay may contribute to compliance concerns and impact the efficiency of audit processes.

  &nbsp Risk of Missing or Misplacing Logbooks:
The risk of missing or misplacing logbooks poses a significant threat, leading to time wastage in locating them. Mismanagement of physical logbooks may result in disruptions to daily operations and potential data loss.
Features

  &nbsp Elimination of Data Integrity and Compliance Issues:
The adoption of Quickflow eLogbook ensures the elimination of data integrity and compliance issues associated with manual entries. Automated processes reduce the risk of errors and ensure adherence to regulatory standards.

  &nbsp Creation of a Paperless Environment:
Moving to eLogs facilitates a transition to a paperless environment, reducing dependency on physical logbooks and enhancing overall operational efficiency.

  &nbsp No Need to Request QA for New Logbooks:
The software eliminates the need to request new logbooks from QA, streamlining the process and ensuring continuous availability for recording essential data.

  &nbsp Automation of Data Across All Departments:
Quickflow eLogbook automate data processes across various departments, ensuring consistency, accuracy, and real-time availability of information.

  &nbsp Seamless Processing of Requests, Issuances, Entries, etc.:
The software streamlines the entire logbook management process, including requests, issuances, and data entries, resulting in a more efficient workflow.

  &nbsp Data Export to Excel and PDF:
Quickflow eLogbook enable the easy export of data to Excel and PDF formats, providing flexibility in data analysis, reporting, and sharing.

  &nbsp Comprehensive Definition of GxP Procedures:
The software offers a comprehensive definition of all Good Practices (GxP) procedures, ensuring adherence to quality standards and regulatory requirements.

  &nbsp Centralized Management of All Logbooks:
All logbooks are centrally managed within a single software platform, improving accessibility, organization, and oversight.

  &nbsp Tracking and Monitoring through Audit Trails:
Audit trails enable the tracking and monitoring of all activities, providing a transparent and traceable record for compliance purposes.

  &nbsp Real-Time Issue Tracking with Query Builder Filter Option:
Real-time issue tracking, coupled with a Query Builder filter option, allows for swift identification and resolution of concerns, enhancing overall operational responsiveness.

  &nbsp Elimination of Human Errors in Entries:
Automated processes significantly reduce the risk of human errors in data entries, ensuring accuracy and reliability.

  &nbsp 24/7 Log Management Availability:
The software provides 24/7 availability for log management, enhancing accessibility and responsiveness to operational needs.

  &nbsp Customizable Log Forms Aligned with Approved SOPs:
Log forms are customizable, aligning with approved Standard Operating Procedures (SOPs), ensuring flexibility and adherence to established protocols.

  &nbsp Flexible Workflow Definition at Log Type and User Levels:
The software allows for flexible workflow definition at log type and user levels, enabling verification and review through controlled workflows.

  &nbsp Elimination of Risks Associated with Misplacing or Losing Physical Log Books:
The shift to Quickflow eLogbook eliminates the inherent risks associated with misplacing or losing physical log books, ensuring the security and integrity of recorded data.

  &nbsp Assurance of Data Integrity and Compliance:
The software provides assurance of data integrity and compliance through automated processes, comprehensive tracking, and adherence to regulatory standards.

  &nbsp Establishment of Business Rules to Ensure Standardization:
Business rules are established to enforce pre-requisites and ensure standardization, enhancing consistency and adherence to defined processes.

  &nbsp Scheduling System Alerts and Reminders for Upcoming Task Deadlines:
The system enables the scheduling of alerts and reminders for upcoming task deadlines, facilitating proactive task management and adherence to timelines.

  &nbsp Real-Time Collaboration with Highly Skilled Teams:
Quickflow eLogbook facilitate real-time collaboration among highly skilled teams, fostering efficient communication and coordinated efforts in logbook management. Benefits   &nbsp eLogbooks reduce the chances of human errors in data entry and recording, as data is directly captured electronically. This ensures higher data accuracy, minimizing the risk of mistakes that could impact product quality or regulatory compliance.

  &nbsp With eLogbooks, data can be entered and accessed in real-time. This enables faster decision-making, as stakeholders have immediate access to critical information, allowing them to address any issues promptly and effectively.

  &nbsp Electronic logbooks centralize data storage, making it easier to manage, organize, and retrieve information. This helps reduce the risk of data loss, and it ensures that historical records are readily available for audits and inspections

  &nbsp eLogbooks offer advanced search functionalities, allowing users to find specific data quickly. This saves time and effort compared to manually searching through physical logbooks

  &nbsp Electronic logbooks promote seamless collaboration among teams and departments. Information can be shared instantaneously, facilitating better communication and ensuring that all relevant stakeholders are informed

  &nbsp As pharmaceutical companies grow, the volume of data and documentation also increases. eLogbooks can easily scale to accommodate the expanding needs of the organization
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Overview UAM Quickflow UAM (User Access Management) IT Admin Analyst Quickflow UAM (User Access Management) is a cutting-edge system with Robotic Process Automation (RPA) technology, overseeing and administering user access privileges within the workforce.

It efficiently monitors management authorizations, streamlining regulatory compliance and providing a seamless audit trail. Rest assured, Quickflow UAM meticulously manages user access rights, minimizing security risks and unauthorized access. Its robustness ensures uninterrupted functionality, making it a reliable and scalable solution for businesses of all sizes.
Reviewer Viewer Analyst User can create,
manage form, submit
form to reviewer, query builder dashboard etc. IT Admin Configure
user, operation, report,
department, product master, disable data etc. Reviewer User can review/
send back/submit the form, review audit trail, query builder etc. Viewer User can view/print pdf sheet, review form audit trail, query builder, analytical dashboard Challenges Quickflow UAM (User Access Management)   &nbsp Manual user access requests involve hardcopy paperwork, multiple signatures, and administrator authorizations, leading to time-consuming and error-prone processes.
  &nbsp Password and Vault management present challenges due to the difficulty in remembering passwords for various systems and resources.
  &nbsp On-time reporting and secure audit trails are crucial for identifying security vulnerabilities and providing reliable data for audits.
  &nbsp Tracking -a large number of end-user access requests, including new accounts, cancellations, and permission adjustments, is complex.
  &nbsp Managing several software licenses, especially per-user licensing with expirations upon employee departure, proves difficult to handle efficiently.
  &nbsp Inadvertently terminating user accounts can jeopardize system security and result in additional license charges.

Features Quickflow UAM (User Access Management) Enhance your quality control operations with a comprehensive set of robust features:
  &nbsp Electronic Access Request:
Initiate access requests effortlessly through a web-based application, accessible anytime and anywhere with a single click.
  &nbsp Eliminate manual: Eliminate manual form filling, saving valuable time and effort.
Gain immediate visibility into access privileges, enabling quick determination of who has access to specific information.
  &nbsp Software License Management:
Easily manage and oversee software licenses.
Monitor software license utilization in real-time, providing insights for effective license allocation.
  &nbsp Password/Vault Management:
Safely store all enterprise application passwords in encrypted form, ensuring maximum security.
Set up automated password expiration mail notifications based on Standard Operating Procedures (SOP).
  &nbsp Easy Account Creation & Termination:
Leverage Robotics Process Automation (RPA) to streamline the creation and modification of user details across all systems, based on designated roles and responsibilities.
Achieve complete and immediate removal of all user access from various resources upon termination, efficiently executed with RPA.
  &nbsp User Life Cycle Management:
Automate the onboarding and offboarding processes for users.
Configure an approval workflow to ensure proper tracking and fulfillment of user access requests.
Utilize RPA to automatically populate Active Directory with data from systems like SAP/HR System, facilitating swift integration for new employees.
  &nbsp Secure Audit Trails:
Automatically generate secure audit trails for all user requests.
Maintain a comprehensive record of access activities, facilitating thorough auditing and compliance tracking.


Benefits Quickflow UAM (User Access Management)   &nbsp Increased Productivity & Efficiency
Swiftly and effectively respond to users' requirements, delivering superior service.
Improve overall efficiency, leading to a more productive work environment.
  &nbsp Cost-Cutting
Achieve cost-effectiveness for businesses by meeting legal and regulatory standards.
Automate time-consuming administrative tasks, enhancing staff productivity.
  &nbsp Data Protection
Ensure the security of information stored in electronic form.
Implement measures to safeguard sensitive data from unauthorized access.
  &nbsp 24*7 Availability
Enjoy uninterrupted accessibility around the clock.
Access information from any system at any time, ensuring seamless availability.



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Overview ELN Quickflow ELN(Electronic Lab Notebook) IT Admin Analyst Introducing Webosphere Electronic Lab Notebook (ELN) software – the ultimate solution for efficient, error-free research. This digital version of a traditional lab notebook streamlines recording and organizing experimental data, protocols, and observations. It replaces paper-based notebooks, enhancing data accessibility, searchability, and collaboration.

With a user-friendly interface, it can easily monitor experiment progress, ensure accurate documentation, and automate report generation for sharing. Tailor the highly configurable software to your specific R&D needs, gaining real-time process insights to swiftly address any challenges. Elevate your research with Webosphere ELN software.
Reviewer Viewer Analyst User can create,
manage form, submit
form to reviewer, query builder dashboard etc. IT Admin Configure
user, operation, report,
department, product master, disable data etc. Reviewer User can review/
send back/submit the form, review audit trail, query builder etc. Viewer User can view/print pdf sheet, review form audit trail, query builder, analytical dashboard Challenges Quickflow ELN(Electronic Lab Notebook)   &nbsp Eliminate errors resulting from illegible handwriting and human mistakes.
  &nbsp Ensure comprehensive documentation of executed processes.
  &nbsp Streamline tracking and management of experimental data.
  &nbsp Reduce costs associated with manual paper-based operations.
  &nbsp Minimize the risk of misplaced or lost experimental data.
  &nbsp Provide real-time visibility into ongoing experiments and research.
  &nbsp Facilitate easy compilation and analysis of existing data.
  &nbsp Ensure seamless compliance with regulatory agencies.
  &nbsp Expedite review and approval processes through automation.
  &nbsp Enable efficient record retrieval for audits and regulatory submissions.
Features Quickflow ELN(Electronic Lab Notebook)   &nbsp Dynamic Experimentation: Users can create formulation experiments dynamically using drag-and-drop functionality, enabling flexible workflows in R&D labs.
  &nbsp Comprehensive Documentation: The ELN ensures compliance with Good Laboratory Practices (GLP) and regulations by documenting laboratory procedures, reducing errors and enhancing data integrity.
  &nbsp Comparative Analysis: Scientists and analysts can compare past experiments within the same or similar projects, promoting collaboration and knowledge sharing among team members.
  &nbsp Efficient Information Management: The ELN automatically updates and provides access to logs and records, saving time on information retrieval and manual updates.
  &nbsp Graphical Reporting: Users can compile and generate graphical reports of selected data, facilitating data analysis and interpretation.
  &nbsp Role-Based Application: The ELN maintains data integrity and access control by assigning specific roles to authorized individuals, ensuring confidentiality and compliance.
  &nbsp Security and Authentication: Active Directory integration and biometrics ensure secure access to the system, and electronic signatures and audit trails enhance data security.
  &nbsp Automated Notifications and Alerts: The ELN sends automated email notifications and escalation alerts for experiment approvals and activities, promoting timely communication and efficient workflow management.
Benefits Quickflow ELN(Electronic Lab Notebook)   &nbsp Increased Efficiency: Minimize repetitive experiments and enhance overall efficiency in research and development activities.
  &nbsp Real-time Visibility: Monitor R&D processes in real-time, ensuring consistent and high-quality outcomes.
  &nbsp Automated Reporting: Automate report generation to save time and minimize errors in data entry.
  &nbsp Regulatory Compliance: Ensure compliance with regulatory requirements through accurate and up-to-date documentation.
  &nbsp Improved Communication: Foster seamless communication among team members, promoting collaboration and understanding.
  &nbsp Cost Savings: Save on production costs by reducing errors and optimizing processes with ELN software.
  &nbsp Scalability: Easily adapt the software to accommodate the changing needs of your business as it grows.
  &nbsp Customizable Templates: Tailor the ELN software to your specific R&D needs with customizable templates.
  &nbsp Reduced Paperwork: Eliminate manual record-keeping, reducing paperwork and the risk of errors associated with it.
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Overview APQR Quickflow APQR(Annual Product Quality Reviews) IT Admin Analyst Webosphere APQR is a powerful software solution designed for creating Annual Product Quality Reviews. It's built on an easy-to-use Low code platform and can be accessed through a web interface. Its main purpose is to help prepare detailed reviews while meeting strict regulatory standards.

The software complies with various regulatory requirements, especially those outlined in USFDA 21 CFR Part-11 and guidelines from MHRA. Additionally, the software prioritizes maintaining the accuracy and reliability of data.
Reviewer Viewer Analyst User can create,
manage form, submit
form to reviewer, query builder dashboard etc. IT Admin Configure
user, operation, report,
department, product master, disable data etc. Reviewer User can review/
send back/submit the form, review audit trail, query builder etc. Viewer User can view/print pdf sheet, review form audit trail, query builder, analytical dashboard Challenges Quickflow APQR(Annual Product Quality Reviews)   &nbsp Manual data collection process is time-consuming.
  &nbsp Complex management of numerous Excel sheets.
  &nbsp Higher risk of misplacing or damaging documents in manual processes.
  &nbsp Lack of traceability in the manual system.
  &nbsp Tedious and intricate status retrieval in manual procedures.
  &nbsp Absence of electronic signatures.
  &nbsp Ineffective collaboration between functional departments during data collection.
  &nbsp Potential data integrity issues in manual processes.
  &nbsp Manual process lacks the ability to send alerts and notifications.









Features Quickflow APQR(Annual Product Quality Reviews)   &nbsp Simplified data entry through pre-populated fields, reducing user effort and man-hours.
  &nbsp Automated generation of APQR documents based on product manufacturing, using predefined templates and date selections.
  &nbsp Statistical analysis and trends provided for key analytical results, including Assay, Water Content, PH, Specific Impurities, and Total Impurities.
  &nbsp Automatic calculation of Mean, Median, and Standard Deviations within the Electronic APQR Software.
  &nbsp Auto-generation of Process Capability metrics such as Cp, CPK, CPU, CPL, UCL, LCL, and Standard Deviations.
  &nbsp Identification of product-specific issues and trends.
  &nbsp Convenient online review and approval processes.
  &nbsp Integration potential with Enterprise software like SAP, ERP, facilitated by Robotic Process Automation (RPA).
  &nbsp Compliance with 21 CFR Part 11 regulations.
  &nbsp Dynamic report generation capabilities.
  &nbsp Email notifications and alerts for activities, including Delays. Benefits Quickflow APQR(Annual Product Quality Reviews)   &nbsp Simplified data entry through pre-populated fields, reducing user effort and man-hours.
  &nbsp Information related to marketing authorization and details of market variations like changes in the label.
  &nbsp The Annual Product Review (APR) software collects batch information such as product code, shelf life, date of production, and date of expiration, as well as pack size. Information on process yields such as granulation, compression, coating, and packaging are also captured.
  &nbsp Other information like raw material, packaging materials, batch failure or batch Rejections, deviations, are captured.
  &nbsp It provides information on process control and analytical test results
  &nbsp Out of specification and out of trend results
  &nbsp Process change requests and other types of change requests like Analytical change requests
  &nbsp Categorized month-wise and condition-wise details relating to the product stability
  &nbsp Provision to capture both child and parent products in the generated APQR document.
  &nbsp Product returns, Market complaints, product recalls
  &nbsp In Process Parameters for Granulation, Compression, Coating, and Packing Processes





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Overview Genius
Lab Quickflow Genius Lab IT Admin Analyst 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.

Genius Lab is tailored to gather data from non-PC-connected instruments such as Balances, Dissolution machines, pH meters, etc. This data is acquired via the RS232 port and securely stored on a server.

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.
Reviewer Viewer Analyst User can create,
manage form, submit
form to reviewer, query builder dashboard etc. IT Admin Configure
user, operation, report,
department, product master, disable data etc. Reviewer User can review/
send back/submit the form, review audit trail, query builder etc. Viewer User can view/print pdf sheet, review form audit trail, query builder, analytical dashboard Challenges Quickflow Genius Lab   &nbsp Standalone instruments in Pharmaceutical industries (e.g., pH meter, analytical balances, polarimeter) lack PC connectivity, resulting in data that cannot be saved as a soft copy.
  &nbsp This situation raises concerns about non-compliance with regulatory requirements, as there is no backup for the generated data.
  &nbsp Backup from these standalone instruments is not feasible, further complicating compliance efforts.
  &nbsp Regulatory guidelines may require these instruments to have backup capabilities, but some older instruments may not even be connected to printers, making them non-compliant for use in GMP laboratories.
  &nbsp Acquiring new instruments is costly, adding to the financial burden for the industry.
  &nbsp The absence of an audit trail facility is another limitation of these standalone instruments, potentially affecting data integrity and traceability. Features Quickflow Genius Lab   &nbsp 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.
  &nbsp 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)
  &nbsp The software allows multiple standalone instruments to connect to a single PC.
  &nbsp Compliance with 21 CFR Part 11 and GxP requirements is met by the system.
  &nbsp Compatibility with instruments having RS 232 ports is ensured.
  &nbsp Old instruments with RS 232 ports can be connected, resulting in cost savings.
  &nbsp Data generated is backed up regularly.
  &nbsp Electronic signatures are supported for authentication purposes.
  &nbsp Different access levels (Analyst, Reviewer, Manager) are available for users.
  &nbsp Previous batches' data can be accessed and reviewed at any time.
  &nbsp Being web-based, the application can be accessed from anywhere with an internet connection. Benefits Quickflow Genius Lab   &nbsp Genius lab software enables the connection of multiple standalone instruments to a single PC.
  &nbsp The software allows the generated data to be saved on the server for convenient access whenever needed.
  &nbsp Easy data backup functionality is provided by the Genius lab software.
  &nbsp Even older instruments with RS 232 port can be connected to the software, facilitating data storage on the server and enabling printouts.
  &nbsp As a result, there is no need to invest in new instruments, reducing the financial burden.
  &nbsp The software provides audit trail capabilities, ensuring data integrity and traceability are maintained. setREVStartSize({c: 'rev_slider_26_9',rl:[1240,1024,778,480],el:[950,768,960,720],gw:[1240,1124,778,480],gh:[950,768,960,720],type:'carousel',justify:'',layout:'fullwidth',mh:"0"});if (window.RS_MODULES!==undefined && window.RS_MODULES.modules!==undefined && window.RS_MODULES.modules["revslider269"]!==undefined) {window.RS_MODULES.modules["revslider269"].once = false;window.revapi26 = undefined;if (window.RS_MODULES.checkMinimal!==undefined) window.RS_MODULES.checkMinimal()}