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The Laboratory Information Management System (LIMS) is now online in SGS’s Life Science Services labs in Singapore and India. The LIMS, BLUEphire - R5, has a dedicated customer approach and is customized to the specific lab’s needs. After a successful pilot stage, SGS has implemented the use of LIMS for all customers on January 2nd in India and January 25th in Singapore. All laboratory staff has been trained on the system to ensure compliance and a smooth transition at every step in the process.

Key points of this system are highlighted below:

Regulatory:

  • FDA 21,CFR Part 11 Compliance
  • Fully Validated
  • Electronic Signature Verification
  • Complete Traceability
  • Audit Trail

Reporting Workflow:

  • Sample registration is documented in the system immediately upon sample receipt
  • Automatic customer notification via email upon sample registration, with reference number and due date for release
  • Methods and quote details are entered into the system
  • Samples are given a unique LIMS assignment number and each is labelled with a barcode for traceability
  • Upon completion of the test, an SGS analyst enters the results in LIMS
  • Out of Specification (OOS)
    • If there are any OOS results, LIMS automatically generates a notification to QA
    • QA will review and update the customer as per SGS OOS procedure
    • Results are reviewed against the raw data and if it is found to be correct, QA will release the results
  • Electronic delivery of the Certificate of Analysis (COA) to the customer along with the invoice
  • The electronic COA is considered the original for any regulatory inspections and no physical signature is needed
  • The customer can request a status update at any time during the work flow described by simply referring to the reference number given

Electronic Documentation:

  • Automatically archived – the electronic COA is kept on file on the SGS Server
  • Maintained data integrity and audit trail is
  • Accepted by local HSA
  • On-Demand Reporting - Customers can print their own COA
  • Ensured traceability – Sample receipt to invoicing or invoicing to sample receipt

ABOUT SGS

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 70,000 employees, SGS operates a network of over 1,350 offices and laboratories around the world.