QuickFlow LIMS
Laboratory Information
Management System
Quickflow eSheet
Calculation Sheet
Quickflow QMS
Quality Management
System
Quickflow DMS
Document Management
System
Quickflow - Calculation sheet for Laboratory analysis
Adeptly automates laboratory calculations, converting them into intuitive web-based forms with meticulous access control and finely gained permissions, ensuring a secure, efficient environment for precise and compliant data handling.
- Overview
- Challenges
- Features
- Key Benefits
Overview
Quickflow eSheet serve as a pivotal element in the pharmaceutical industry, providing a robust solution for automating and streamlining routine calculations performed in quality control. Aligned with the regulatory standards, Quickflow eSheets, a 21 CFR Part 11 compliant and GAMP category 4 software, is specifically designed to enhance efficiency and compliance in the realm of calculation sheets and forms. This automation not only reduces manual interactions but also establishes a secure framework that allows Quality chemists to execute processes with minimal oversight.
The significance of automating calculations in the pharmaceutical industry is underscored by the evolving role of modern chemists. At the laboratory scale, Quickflow eSheets enable chemists to test a greater number of samples with enhanced accuracy and granularity. This contributes to a more profound understanding of the chemical processes involved, fostering improved research and development outcomes.
By automating calculations, pharmaceutical companies can enhance accuracy, reduce the risk of errors, and adhere to regulatory standards. Quickflow eSheets, with their compliance-driven design, emerge as a valuable tool in the pharmaceutical landscape, supporting a seamless integration of technology and compliance to elevate the efficiency and safety of critical processes.
Industry Challenges
⦿ In Pharmaceutical industries many calculations (Ex: Assay by HPLC, Impurities by HPLC, Residual solvents by GC etc. are performed either manually using a validated calculator or using validated excel sheets.
⦿ Manual calculations required more efforts and man hours, which decreases the efficiency of the analyst and Quality control.
⦿ During manual calculations, there are high chances of data integrity issues.
⦿ For manual calculations reviewer also need to verify the results using a calculator, which is a time-consuming process.
⦿ Using excel sheets calculations can be done quickly, but the results cannot be saved as a soft copy.
⦿ During the excel sheet review if any typo error is observed, again all the fields has to be entered and print to be taken, which is a time consuming process.
⦿ If the excel sheet is closed by mistake before taking the print, again the complete data has to be entered.
⦿ There are chances of multiple excel sheets getting generated in the computer, as excel sheet can be ‘Saved as’, which in turn is a data integrity issue.
⦿ Previous batches data cannot be viewed by using the excel sheets.
⦿ Tracking of changes made to excel sheets is difficult.
Features
⦿ Efficient Data Entry with Pre-populated Fields:
Users can enter data effortlessly with the aid of pre-populated fields, significantly reducing the manual effort and man-hours required for data input.
⦿ Multi-level Review Process:
The system supports multiple review levels, enabling a thorough examination of the entered data. In case of errors, the form can be sent back to the analyst for correction before advancing to subsequent review stages.
⦿ Flexible Saving and Editing:
Entries on the sheet can be saved at any point during data input, providing flexibility to users. This feature allows for incremental progress and easy editing before final submission.
⦿ Data Retrieval and Historical Access:
Users have the capability to fetch previous data at any time, allowing for reference and comparison. This historical access enhances data traceability and facilitates informed decision-making.
⦿ Web-based Accessibility:
Being a web-based application, Quickflow eSheets can be accessed from any location with internet connectivity, providing users the convenience of working remotely and promoting collaborative workflows.
⦿ Comprehensive Audit Trail:
The system offers full audit trail support, enabling real-time tracking of changes made to the data. This feature ensures accountability, transparency, and compliance with regulatory standards.
⦿ Partial Entry and Editing:
Data entered partially can be saved and edited at any stage before submission for review. This flexibility allows users to revisit and refine their entries as needed, contributing to data accuracy.
⦿ Batch-wise Result Retrieval and Export:
Results for all analyzed batches can be retrieved at any time, offering a holistic view of the data. Additionally, the capability to export data to Excel facilitates easy trend analysis and reporting.
Key Benefits
⦿ Prepopulated Data from Master Records:
Quickflow eSheets streamline data entry by pulling prepopulated information from master records, eliminating the need for manual entry. This not only reduces the likelihood of errors but also saves significant time and effort.
⦿ Online Review Capability:
The system facilitates real-time online reviews of forms, allowing analysts, reviewers, and managers to collaboratively assess and validate data entries. This feature promotes efficiency in the review process.
⦿ Regulatory Compliance:
Quickflow eSheets adhere to regulatory standards, ensuring compliance with 21 CFR Part 11 and GxP requirements. This commitment to regulatory guidelines provides a secure and reliable framework for pharmaceutical data management.
⦿ Electronic Signatures:
The system incorporates electronic signature functionality, offering a secure and legally recognized method of authorizing and approving entries. This feature enhances the integrity and traceability of the data.
⦿ Access Control Levels:
Multiple access levels are configured to cater to different roles within the organization, including Analyst, Reviewer, and Manager. This ensures that individuals have appropriate permissions and responsibilities based on their roles.
⦿ Data Retrieval for Previous Batches:
Users have the ability to retrieve data from previous batches at any time. This historical access enables quick reference, comparison, and trend analysis, contributing to informed decision-making.
⦿ Web-based Accessibility:
Being a web-based application, Quickflow eSheets offer the flexibility to be accessed from any location with an internet connection. This accessibility promotes remote work capabilities and facilitates collaborative data management.
⦿ Customizable Workflow Configuration:
The system allows for the configuration of custom workflows, accommodating specific organizational processes and requirements. This flexibility ensures that the software aligns seamlessly with the unique workflow needs of the pharmaceutical company.
