QuickFlow LIMS
Laboratory Information
Management System
Quickflow eSheet
Calculation Sheet
Quickflow QMS
Quality Management
System
Quickflow DMS
Document Management
System
Quickflow - Reference and Working Standards Mangement
Meticulously oversees laboratory standards, ensuring regulatory compliance and enhancing accuracy, traceability, and reliability in pharmaceutical testing and analysis.
- Overview
- Challenges
- Features
- Key Benefits
Overview
Quickflow Standard Management is an 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.
This software is fully aligned with the rigorous stipulations outlined in the USFDA 21 CFR Part-11 guidelines and other pertinent regulatory benchmarks.
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.
Industry Challenges
⦿ Maintaining multiple logbooks for working standards, reference standards, impurity standards, and reference solutions.
⦿ Risks of non-compliance and data integrity issues due to manual recording of entries in the standards usage logs.
⦿ Manual management and tracking of expiry dates for all standards, leading to decreased efficiency.
⦿ Increased likelihood of using expired standards for analysis due to difficulties in manually tracking expiry dates.
⦿ Challenges in managing Certificate of Analysis (COA) manually.
⦿ 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.
⦿ 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.
⦿ Manual Standard Management systems may not adequately address compliance risks, leaving organizations vulnerable to non-compliance with industry standards and regulations.
⦿ 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.
⦿ Physical documents can be susceptible to loss, damage, or unauthorized access.
Features
⦿ Compliance with 21 CFR Part 11 and GxP Standards:
➮The system ensures compliance with 21 CFR Part 11, which sets the criteria for electronic records and signatures, and GxP standards, ensuring the quality and integrity of data in the life sciences industry.
➮Robust security measures, including user authentication, access controls, and audit trails, are implemented to meet regulatory requirements.
⦿ Automatic Generation of Unique Reference Numbers:
➮The system generates unique reference numbers for different types of standards, ensuring a systematic and traceable identification method.
➮Each reference number is algorithmically generated and linked to specific attributes of the standard, facilitating easy retrieval and organization.
⦿ QR Code Generation upon Standard Registration:
➮Upon standard registration, a unique QR code is automatically generated and associated with the standard.
➮The QR code contains essential information about the standard, allowing for quick and accurate tracking of standard details through mobile devices or scanners.
⦿ Time-Saving Usage Entry through QR Code Scanning:
➮Analysts can efficiently enter usage data by simply scanning the QR code using handheld devices, reducing data entry errors and saving valuable time.
➮The system captures real-time usage information, providing instant updates on the standard's status and availability.
⦿ Multiple Review Levels for Standard Approval Process:
➮The system supports a multi-tiered approval process, allowing standards to undergo thorough reviews by different stakeholders.
➮Each review level is defined with specific criteria, ensuring a comprehensive evaluation before final approval.
⦿ Prevention of Using Expired Standards:
➮The system restricts entries for standards that have expired, preventing the use of outdated or invalid standards in testing or production.
➮Notifications and warnings are issued to users attempting to access or utilize standards with expired certifications.
⦿ Generation of Summarized Reports:
➮The system provides customizable and detailed reports summarizing standard-related activities, usage patterns, and approval statuses.
➮Reports can be generated on-demand or scheduled for regular distribution to relevant stakeholders.
⦿ System-Generated Certificate of Analysis (COA):
➮Upon completion of testing or analysis, the system automatically generates a comprehensive COA for working standards.
➮The COA includes detailed information on the standard's composition, testing results, and compliance with specifications.
⦿ Automatic Updates and Alerts through Email Notifications:
➮Email notifications are sent at least 60 days in advance of standard expiration or exhaustion, ensuring timely awareness and action.
➮The system keeps users informed about any changes in standards, ensuring ongoing compliance and preventing disruptions.
⦿ Fully Audited Trial Capability:
➮The system maintains a detailed audit trail, capturing every action and change made within the system.
➮Audit logs are regularly reviewed to ensure data integrity, traceability, and compliance with regulatory requirements.
Key Benefits
⦿ Elimination of Manual Logbooks:
➮The system captures and centralizes all standard data, eliminating the need for manual logbooks.
➮A comprehensive digital record is maintained from the procurement stage to the standard's expiry, ensuring data accuracy and accessibility.
⦿ Ensured Data Integrity:
➮All entries, modifications, and updates are made within the system, ensuring data integrity and reducing the risk of errors associated with manual record-keeping.
➮Audit trails provide a transparent history of all actions, enhancing accountability and compliance.
⦿ Time-Saving Expiry Date Tracking:
➮Analysts can effortlessly track expiry dates with a single click, providing quick and efficient access to critical information.
➮Real-time expiry date tracking minimizes the risk of using expired standards and facilitates proactive planning for replacements.
⦿ Prohibition of Using Expired Standards:
➮The system enforces strict measures to prohibit the use of expired standards, preventing deviations in testing or production processes.
➮Automated alerts and system restrictions prompt timely actions, saving valuable time and resources.
⦿ Preparation, Approval, and Online Viewing of Certificate of Analysis (COA):
➮The system streamlines the entire COA process, from preparation to approval, within a centralized platform.
➮Authorized personnel can conveniently view COAs online, ensuring quick access to critical information and reducing paperwork.
⦿ Effective Management of Standards Based on Vial Numbers and Quantities:
➮The system allows for detailed tracking and management of standards based on specific identifiers, such as vial numbers and quantities.
➮Inventory levels and usage patterns can be easily monitored, optimizing stock levels and preventing shortages or overstocking.
⦿ System-Generated Alerts Prior to Standard Expiry or Exhaustion:
➮Automated alerts are generated well in advance of standard expiry or exhaustion, allowing for timely actions and preventing disruptions in operations.
Notifications are sent to relevant stakeholders, ensuring a proactive approach to standard management.
⦿ Efficiency and Productivity Gains:
➮The standard management system's automation of workflows and reduction of manual tasks result in significant time savings for employees.
➮Increased efficiency allows personnel to focus on more critical tasks, enhancing overall productivity.
⦿ Standardized Processes for Consistency:
➮Standardized processes within the system ensure that everyone in the organization follows consistent guidelines and practices.
➮This consistency leads to higher quality products and services, reducing the likelihood of errors and improving overall compliance.
⦿ Cost Savings through Streamlining Processes:
➮By streamlining processes, reducing errors, and enhancing compliance, the standard management system contributes to long-term cost savings.
➮Efficient resource utilization and minimized risks result in a more cost-effective operation over time
