tQmlab is a suite for LiMS (Laboratory information Management System), QMS, ELN, Stock, Instrumen Integration and DMS etc., for multi location, 24 x 7 access as per USFDA 21 CFR Part 11 regulatory compliance.
3. • Pharmaceutical
• Research and Development
• Clinical Research
• Contract Research Laboratories
• Chemical Industries
• Diary, Food and Beverages
• Forensic
• Oil & Gas
• Hospitals & Diagnostics
4. A Complete Solution for Laboratory Automation
• Adherence to Good Laboratory Practices
• Built-in REGULATORY Report Management.
• USFDA - 21CFR Part 11 - ICH Q7 GLP & cGMP Guidelines.
• Built-in Change Management.
• 100% Secured - Web Technology.
• Seamless integration with ERP and instrument interface.
5. LAB
• Expert Review
• Stability Management
• Specification Management
• Administration
• Multi Lab Capacity
• Work Station Management
• Instrument Management
• Reports & Queries
• Customer portal
• Barcode & RFID Integration
• Sample scheduling
• Pre logon samples
• Sample Booking
• Receive in Lab
• Work Assignment
• Sample Reassignment
• Test and Formulae
authoring Wizards
• Results Entry
• Review and Approval
Workflows
7. Benefits towards a LAB
• Efficiency – No wastage of time, Quick reporting, No errors
• Productivity – No repeated work, Data at finger tips, Quick decisions
• Accuracy – Predefined SOPs, System driven procedures, Alerts & well
maintained instruments
• Security – Unique user id & Passwords, Role based privileges
• Regulatory Compliance – With Authoring Wizards all the regulatory
compliances can be met
• Quality Control – Data capturing, Streamlined Lab activities
8. R&D and Project Management
• Integrated Lab Module with Electronic Lab Notebook
• Integration With Chemdraw
• Method Developments
• Method Validations
Task and Timesheet Management:
• Task Management
• Tracking of workflows
• Reporting
• Productivity
• E-mail Notifications and Alerts
9. Document Management System
• Change of history storing facility, Tracking and versioning of change. The
system will define the roles and responsibilities for approved work flow
and privilege.
• Technology Transfer Documents (TTD)
• Analytical Test Procedure (ATP)
• Standard Test Procedure (STP)
• Specifications
• Validation Protocol
• Validation Report
• Design of Experiment Protocols
• Development Protocols and Reports
• SOP / IOP / EOP (Standard / Instrument / Equipment Operating
Procedure)
10.
11. Stock & Production
• STOCK
• Inward Stock
• Outward Stock
• Stock Position and Search
• Reports
• Alerts
• PO’s & Invoice Management
• PRODUCTION:
• BMR Management
• Production Plans
• Seamless Integration with ERP and integration with Labs
12. Customer Portal
• MIS Reports
• Online Reporting to the Customer Interface
• Tracking of Reports
• E-mail notifications and Alerts
• Data on Fingertips
13.
14. Health Management System
HEALTH MANAGEMENT SYSTEM:
During the appointment / induction of a new employee -
Pre-Inspection Health Report - Status :
Sr No: / Name of the Emp / Emp ID / Emp Department / Report Status : Submitted /
Not Submitted;
Frequency 6 / 12 months / Others
Periodic Health Check-up Report Status :
Year / Frequency / Unit / Sr No: / Name of the Emp / ID / Department / Next Due Date
Report Assessment Status :
OHC (Occupational Health Centre)
Doctor : Approval / Not Approval / Subject to re-inspection;
Doctor's Name / Panel ID No: /Agreement Forced Date /
Expiry Date / Service : Private / Govt
15. Calibration Module
Calibration Scheduling in Departments.
Calibration Reminders for Vendors.
Online Management for the Calibration Records & Calibration certificates.
Integration with Lab Modules and QMS systems.
16. QC & QA - Training Management
• Manage Courses / Modules and Assessments
• Manage Training Schedule Course
• Course Requests and Approvals flow
• Manage Companies Organization flow
• Manage User/ Admin / Management Role
• Management Certificate
• Customizable Test Results, Reports, Attendance etc.,
17. 17
Advantages
ANALYSTS
• Wasting time in doing repeated works
• Passion for science is dominated by Management of work.
• Reporting is the most time taking task
LAB MANAGERS
Regular audits keeps us on toes
Nearly half of our time is spent with auditors, instead of spending for customers and business
More focus is on administration, rather than on business
Managing Multiple Labs at different locations is the toughest job
MANAGEMENT
• Business (Repeated Business and New Business)
• Customer Satisfaction
• FDA Approvals
• Competition
• Audits
• Administration & Labor Costs