Lifescience

Lighthouse's LMS Pharma System

LIGHTHOUSE provides monitoring equipment for recording, alerting and reporting critical cleanroom and laboratory processes according to FDA / GMP regulations. Our systems meet, after going through all steps of the GAMP V model, the current FDA 21 CFR Part 11 guidelines.

The LMS Pharma System is a compact measuring system with full network support. The LMS Pharma software package is developed and maintained according to GAMP5 regulations (audit trail) and complies with FDA 21 CFR Part 11 guidelines. The FDA has set Code 21 of Federal Register Part 11: Electronic records, Electronic Signatures at behalf of electronic documents.

Topics as control, security and audit trails are covered in this document. Lighthouse offers systems designed to meet the requirements of 21 CFR Part 11.

Important LMS Pharma specifications:

  • Sensor inputs:
    The FMS is capable of reading various analog and digital sensors such as temperature, relative humidity, pressure, air velocity, particle counts, conductivity, TOC, CO2, N2, etc.
     
  • Ease of use:
    Presentation of the readings is provided by a simple graphical interface: the Node View. This client application provides various users, including operators, managers, quality control with the possibility to manage and report the measured values. After a training every user is able to found his or her way in LMS.
     
  • Stability:
    The LMS system is designed for the continuity of data supply. The system is equipped with a monitoring engine, which is active 24/7. By using a “fail-over”(buddy) system full redundancy is achieved. Lighthouse guarantees that with a Server Buddy system the up is 99.9%
     
  • SQL Database:
    The protected database can be equipped with Microsoft SQL, MySQL, Broland Interbase, PostgreSQL and ODBC. Mirroring, OPC and Modbus is supported.
     
  • Audit Trails:
    Several reports can be provided such as alarms and confirmations, events, log out/in data and data entry users

     
  • Alerting:
    Very extensive early warning capabilities via email, SMS or TCP / IP.

     
  • Reporting:
    Manual and automated reporting functions with PDF export functions.

     
  • Validation:
    The Lighthouse by LMS systems can be delivered turn-key. Validation documentation according to current FDA / GMP regulations.