Solution for NIBSC

Modules Implemented

Study Plan & Specification Managment

Sample Registration

Manual Results Entry

ELN & SDMS based automatic results capture

Instrument interfacing (ELN & SDMS)

Batch creation

Release Menagment

Instrument Calibration and Maintenance

Inventory Managment

Reporting

Email alerts

Dashboard

Integration with several external systems including PAN European government systems

Integration with ADS

Implementation approach

Here you can learn more about our implementation approach.

1 Initiation

1. Kick-Off - Project Plan

2. Requirement Analysis

3. Gap Analysis

4. Project Plan Update

5. Risk Plan review

6. FRS Sign-off

2 Development

1. Product Configuration and/or Customisation

2. Testing

3. Review and Corrections

4. Legacy Data Migration

5. Report Development

6. Test Script Execution

7. Risk Review

3 Implementation / Validation

1. Instalation and IQ

2. Data Migration

3. OQ

4. Implementation Review

5. Master Data Managment

4 Training / Validation

1. Administrator Training

2. Power User Training

3. End User Training

4. Production Qualification (PQ)

5. Prepere for Go-Live

5 Closure / Support

1. Risk Review

2. Go Live

3. Go Live support

4. Enrolment to Support Phase

Business benefits

LIMS is providing full coverage of all LAB business processes resulting in superior speed, quality and integration.

Speed

  • Quicker batch release (manufactures are delighted)
  • Quick to take action due to automated alerts
  • Certification, re-certification takes much less time
  • Customer satisfaction improved (reduced TAT - Turn Around Time)

Quality

  • LIMS is providing full coverage of all LAB business processes
  • Excellent traceability of samples, results and release of certificates
  • Batch components are traceable 1-to-1 & 1-to-many
  • Better compliance to quality standards (GLP, 21 CRF Part 11, Eudralex)
  • High and transparent visibility of status

Integration

  • Automation achieved (Instrument interfacing)
  • Integration with external database
  • Integration with EDQM database

Control testing of biological medicines

NIBSC act the UK's OMCL performing OCABR testing of biological medicines following guidelines of the EDQM. NIBSC test Centrally Authorised Products (CAP) for carrying out independent official batch release testing of biological medicines. Each batch is examined and approved, independently from the manufacturers, and issued with a EU/EEA OCABR certificate before being released onto the market.

Biological standards and reference materials

NIBSC has a landing international role in preparing, evaluating and distributing international biological standards and other biological reference materials, supplying over 90% of these for the WHO.

Applied research

NIBSC carries out an active high-quality research programme directly related to its strategic aims, carried out by internationally respected scientists, attracting significant external funding and generating an impressive publication output.

Work with the World Health Organisation (WHO)

NIBSC is the leading WHO Collaborating Centre and International Laboratory for Biological Standards, Essential Regulatory Laboratory (ERL) for Influenza, WHO Collaborating Centre for Reference & Research on Poliomyelitis and the WHO Global Specialised Polio Network Laboratory.

Expert services and contracting lab

NIBSC provides a number of experts services to help assure the quality of biological medicines and diagnostic tests for complex biological analyses and performing tests for other organisations on request.

Case study

Here you can find short description of the project for the National Institute for Biological Standards and Control in UK.

LIMS & ELN

  • Implementation
  • Commissinoing
  • Validation
  • Training

WEB application

200+ users
10 labs
10 integrated instruments

For other our LIMS references please go to
www.solution4labs.com or www.agaramtech.com

Clients

We managed to develop a variety of solutions for our clients located all over the world.

Our products are distinguished by innovative approach, flexibility and high quality.

Our software is used by various industry laboratories, such as pharmaceutical, biotechnology, food production, biobanks, healthcare, petrochemicals, contract laboratories, forensics, manufacturing, environmental protection and research institutions.

Clients who chose LIMS

We have worked for a variety of companies from many different fields, always delivering top-notch results.

  • Sitec Labs
  • Danone Nutricia
  • Novartis
  • Inspectorate
  • Cipla
  • Piramal

Contact us

Request a demonstration of the system or a meeting.