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Square Pharmaceuticals Ltd.
Prepared By,
Md. Abrar Mahir Khan
Technical Services Department
EQMSELN
LIMS TRIMS
Stability
Instrument
& CDS
integration
Inventory
 1st web demonstration held on 12 Jan’15 by Novatek, Canada
 Presentation by Mr. Sudhakar Kasturi , Product Manager - Chromeleon and Informatics , Thermo Fisher Scientific. held on 23 Feb’15
 Presentation by Mr.Maarten van, Account manager informatics, Thermo Fisher Scientific. held on 24 MAY ’15
 Initial presentation given by Mr. Suddha from Labware LIMS on 20 Aug’ 15 at Dhaka Unit
 Arranged WebEx demonstration on 17 Aug’ 15 at Dhaka Unit from Caliber, India
 Conference with SAP India hold on 29 Mar ’16
 LIMS URS received on 23 Feb’16
 EQMS URS received on 09 Mar’16
 TRIMS URS received on 19 Mar’16
 LIMS 1st Phase (EQMS & TRIMS) approval done on 31 Aug’ 16
 Agreement between SQAURE & LABWARE signed on 16 Nov’ 16
Fig : Agreement Signing
Labware
 LabWare was founded in 1989 by Vance Kershner who was originally an Engineer at the Dupont
Chemical Company, Wilmington, DE, U.S.A.
 LabWare LIMS is their flagship and strategic LIMS product. This software has been developed and
refined over 20 years.
 Footprint : Teva, Astrazenca, Apotex, Novartis , J&J etc.
 Bangladesh market will be taken care by Labware India, who is part of LabWare EU and incorporated as
branch operation of LabWare UK from 2006
Core Team
Name Designation Department Work
Station
Responsibility
Mr. Faruk Hossain Sr. Executive Validation
and
Calibration
Dhaka unit Overall Project Manager. Manage scope of the project, budget and quality.
Simplifying and standardizing business processes and getting the business to
benefit from using a standard package
Ms. Sukla Mondal Sr. Executive Quality
Assurance
Dhaka unit Requirement spec, Static Data, Validation OQ/PQ, Documentation
Mr. Uzzal Hossain Executive Quality
Control
(Compliance)
Dhaka unit Requirement spec, Static Data,
New Business Processes Change Manager (SME role),Documentation
Mr. Hanif Sikder Executive Quality
Assurance
Dhaka unit Requirement spec, Static Data,
New Business Processes Change Manager (SME role),Documentation
Mr. Muzahid
Hasan Tusher
System
Engineer,
Executive
Square
InformatiX
Limited
Dhaka unit Responsible for setting up the IT infrastructure. This includes the servers,
networks, databases and Citrix/web servers where necessary. This role is
also responsible for backup and disaster recovery.
Note – Square has to select 1 / 2 person as System Administrator for day to
day management of the system. He/she should be involved in all phases and
work closely with LW consultant. Responsible for all configuration package
installation released by LW time to time. Its recommended that the System
Admin should have knowledge of processes also
Mr. Amirul Islam System
Engineer,
Executive
Square
InformatiX
Limited
Dhaka unit
Mr. Tushar Executive HRD Dhaka unit Requirement spec,Static Data,
SME for TRIMS
Supporting Team
Mr. Rakibul Islam Asst. Manager,
System
Operations
Square InformatiX
Limited
CHQ
Support the respective core group
Mr. Mushfiqul
Islam
System
Administrator,
System Operation
Square InformatiX
Limited
CHQ
Mr. Nurul Islam Sr. Executive HRD CHQ
Mr. Khosruzzaman Executive Quality Assurance Dhaka unit
Mr. Mahadi Hasan Executive Quality Control Dhaka unit
Mr. Abrar Mahir
Khan
Executive TSD CHQ
Advisory Body
Mr. Tarun Chugh Head of QA Quality Assurance Dhaka unit
The Advisory Board retains responsibility for approving the business
case, securing the agreed resources required to undertake the
project, and approving the Project & Quality Plan. Communicating
with Project Manager for project updates and with other senior
managers and creating the environment required for the project to
succeed.
Mr. Shareefkhan AGM Quality Control Dhaka unit
Mr. Bimal Chandra
Saha
AGM TSD CHQ
Ms. Salina Akhtar AGM A&F CHQ
Mr. Ahmed U
Bhuyian
GM Square InformatiX
Limited
CHQ
Mr. Nawabur
Rahman
Director, Technical
Operations
Production Dhaka unit
Mr. Rajiv Rana Sr. Manager HRD Dhaka unit
 Less Quality Events Over Time
 Reporting Efficiency & Effectiveness
 Project on-time completion
 Automatic notification, distribution and records assignment has resulted in a
reduced time-to-closure for complaints
 Improve the complaint handling and investigation process
 Tailored training management
 To be paperless…
Thank you…

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Presentation

  • 1. Square Pharmaceuticals Ltd. Prepared By, Md. Abrar Mahir Khan Technical Services Department
  • 3.  1st web demonstration held on 12 Jan’15 by Novatek, Canada  Presentation by Mr. Sudhakar Kasturi , Product Manager - Chromeleon and Informatics , Thermo Fisher Scientific. held on 23 Feb’15  Presentation by Mr.Maarten van, Account manager informatics, Thermo Fisher Scientific. held on 24 MAY ’15  Initial presentation given by Mr. Suddha from Labware LIMS on 20 Aug’ 15 at Dhaka Unit  Arranged WebEx demonstration on 17 Aug’ 15 at Dhaka Unit from Caliber, India  Conference with SAP India hold on 29 Mar ’16  LIMS URS received on 23 Feb’16  EQMS URS received on 09 Mar’16  TRIMS URS received on 19 Mar’16  LIMS 1st Phase (EQMS & TRIMS) approval done on 31 Aug’ 16  Agreement between SQAURE & LABWARE signed on 16 Nov’ 16 Fig : Agreement Signing
  • 4. Labware  LabWare was founded in 1989 by Vance Kershner who was originally an Engineer at the Dupont Chemical Company, Wilmington, DE, U.S.A.  LabWare LIMS is their flagship and strategic LIMS product. This software has been developed and refined over 20 years.  Footprint : Teva, Astrazenca, Apotex, Novartis , J&J etc.  Bangladesh market will be taken care by Labware India, who is part of LabWare EU and incorporated as branch operation of LabWare UK from 2006
  • 5. Core Team Name Designation Department Work Station Responsibility Mr. Faruk Hossain Sr. Executive Validation and Calibration Dhaka unit Overall Project Manager. Manage scope of the project, budget and quality. Simplifying and standardizing business processes and getting the business to benefit from using a standard package Ms. Sukla Mondal Sr. Executive Quality Assurance Dhaka unit Requirement spec, Static Data, Validation OQ/PQ, Documentation Mr. Uzzal Hossain Executive Quality Control (Compliance) Dhaka unit Requirement spec, Static Data, New Business Processes Change Manager (SME role),Documentation Mr. Hanif Sikder Executive Quality Assurance Dhaka unit Requirement spec, Static Data, New Business Processes Change Manager (SME role),Documentation Mr. Muzahid Hasan Tusher System Engineer, Executive Square InformatiX Limited Dhaka unit Responsible for setting up the IT infrastructure. This includes the servers, networks, databases and Citrix/web servers where necessary. This role is also responsible for backup and disaster recovery. Note – Square has to select 1 / 2 person as System Administrator for day to day management of the system. He/she should be involved in all phases and work closely with LW consultant. Responsible for all configuration package installation released by LW time to time. Its recommended that the System Admin should have knowledge of processes also Mr. Amirul Islam System Engineer, Executive Square InformatiX Limited Dhaka unit Mr. Tushar Executive HRD Dhaka unit Requirement spec,Static Data, SME for TRIMS
  • 6. Supporting Team Mr. Rakibul Islam Asst. Manager, System Operations Square InformatiX Limited CHQ Support the respective core group Mr. Mushfiqul Islam System Administrator, System Operation Square InformatiX Limited CHQ Mr. Nurul Islam Sr. Executive HRD CHQ Mr. Khosruzzaman Executive Quality Assurance Dhaka unit Mr. Mahadi Hasan Executive Quality Control Dhaka unit Mr. Abrar Mahir Khan Executive TSD CHQ Advisory Body Mr. Tarun Chugh Head of QA Quality Assurance Dhaka unit The Advisory Board retains responsibility for approving the business case, securing the agreed resources required to undertake the project, and approving the Project & Quality Plan. Communicating with Project Manager for project updates and with other senior managers and creating the environment required for the project to succeed. Mr. Shareefkhan AGM Quality Control Dhaka unit Mr. Bimal Chandra Saha AGM TSD CHQ Ms. Salina Akhtar AGM A&F CHQ Mr. Ahmed U Bhuyian GM Square InformatiX Limited CHQ Mr. Nawabur Rahman Director, Technical Operations Production Dhaka unit Mr. Rajiv Rana Sr. Manager HRD Dhaka unit
  • 7.  Less Quality Events Over Time  Reporting Efficiency & Effectiveness  Project on-time completion  Automatic notification, distribution and records assignment has resulted in a reduced time-to-closure for complaints  Improve the complaint handling and investigation process  Tailored training management  To be paperless…