Clients

Consulting Experience

Since founding Segalstad Consulting in 1995, I’ve provided consulting services to more than fifty companies in a dozen countries around the world.

A complete overview of Segalstad Consulting’s current and former clients are listed below, although client names are withheld due to confidentiality agreements. However, if you as a prospective client wish to talk to any of these, please contact Segalstad Consulting and request a reference from the list below. In most cases, such requests are granted.

Norwegian Chemical Supplier No. 1 1995 and Norwegian Chemical Supplier No. 2 1996

Total quality management system: Written all parts of the TQM comprising quality manual and SOPs, covering all aspects of quality of products and service, and legal requirements from the Working Environments Act.

 

Royal Pharmaceutical Society of Great Britain 1995, 1996, and 1997

Teaching team for 3-day classes in “Practical Computer Validation”.

 

Swedish Pharmaceutical Company No. 1 1995

LIMS: Written User Requirements Specification (URS) for a new LIMS.


Swedish Pharmaceutical Company No. 2 1995-98

  • Computer Systems Validation Handbook: Reviewed and suggested corrections.
  • LIMS: Supplier audit, co-project leader for implementation, responsible for SOPs and validation.
  • Clinical system 1: Supplier audit, SOPs, validation.
  • Clinical system 2: Retrospective validation. Supplier audit.
  • Chromatography system: Prospective and retrospective validation. Supplier audit.
  • 1 day seminar: Quality assuring the IT systems according to GMP and GLP.
  • Internal audits of several types of IT systems’ validation protocols, validation documentation and reports.

 

Swedish Pharmaceutical Company No. 3 1995-96

  • Chromatography system: System validation and SOPs, 3 Supplier audits.

 

Swedish Medical Device Company No. 1 1996-99

  • 2 x 1 day seminar: Quality assuring the lab computer, and what standards to apply in this industry
  • 2 short seminars: What is LIMS, and Quality Assurance for an IT department
  • LIMS: 2 Supplier audits, implementation, validation, SOPs

 

Swedish Pharmaceutical Company No. 4 1997-98

  • LIMS: Implementation, validation, SOPs

 

Swedish Pharmaceutical Company No. 5 1997-98

  • LIMS: Assessment of Supplier replies to URS, Supplier audit, validation and SOPs
  • 2 day seminar: Validation of LIMS in the pharmaceutical industry

 

Norwegian Pharmaceutical Raw Material Company No. 1 1997-98 and 2000-2001

  • Seminar: Validation of computer systems
  • SAP: Supplier audit
  • LIMS: URS, in-house test plan, Supplier audits

 

Danish Pharmaceutical Company No. 1 1998-2003

  • LIMS Project team member with 50% time for nearly 2 years: URS, in-house test plans, quality/validation plan, Supplier selection, SOPs, system validation, implementation & qualification of static data in system.
    • 3 Seminars: 21 CFR Part 11 & Validation of LIMS, tailored to the company’s internal requirements and the chosen LIMS
    • Toxicology LIMS: URS, assessing Supplier answers to URS, validation plan
    • Drug analysis LIMS: Assessing documentation
    • 21 CFR Part 11 project: Checklists, class, assessment of approx. 30 systems with action suggestions
    • Batch documentation management system: Validation plan

 

Norwegian Governmental Agency No. 1 1998-1999

  • Seminar: Validation of LIMS in the EN 45001 accredited environment
  • LIMS: implementation, validation, Standard operating procedures (SOP)

 

Norwegian Accreditation 1998

  • Seminar: Year 2000 problem in the accredited laboratory

 

Norwegian Pharmaceutical Company No. 1 1999-2001

  • LIMS: Feasibility study
  • MRP: URS, Supplier audit

 

Norwegian Pharmaceutical Company No. 2 2000

  • Seminar: LIMS project and system validation
  • LIMS: Quality/validation plan

 

Swedish Medical Device Company No. 2 2000-2002

  • Seminar: LIMS project and system validation
  • LIMS: URS, assessment of Supplier answers, Supplier audit, leading the validation process
  • Class: LIMS validation, 21 CFR 11 and GMP requirements

 


Norwegian Pharmaceutical Company No. 3 2001-2003
·       Short seminar: 21 CFR Part 11
  • Class for 100 employees: 21 CFR Part 11
  • Workshop: LIMS validation, status and plans
  • 2 day workshop: validation of computer systems used in production and laboratories, special emphasis on instruments
  • Maintenance software: Validation

 

Open Classes Norway 2001
  • 21 CFR Part 11: Interpretation of the regulations, and practical implementation
  • Validation of IT system: Which activities are included, and how to handle them

 

Open Classes Finland 2001
  • 21 CFR Part 11: Interpretation of the regulations, and practical implementation
  • Validation of IT system: Which activities are included, and how to handle them

 

Swiss Pharmaceutical Company No. 1 2001-2002

  • Chromatography system: Supplier audit
  • LIMS system: Supplier audit, OQ protocol / plans
  • MRP system: Supplier audit

 

Norwegian Medical Device Company No. 1 2001

  • Medical device: OQ/PQ plan, testing and report

 

Norwegian Pharmaceutical Company No. 5 2001
  • MRP system: Supplier audit
  • Internal audit of IT systems and their handling according to GMP, 21 CFR Part 11 and internal quality system

 

Norwegian Pharmaceutical Company No. 6 2001 – 2006
  • QA system top level: SOPs for IT systems, plus review and rewriting later on risk-based approach
  • Acting as QA manager for IT systems for 1 month 2003
  • Document Management system: SOPs and 21CFR11 status and test plans
  • SAP rollout: Review of validation (IQ, OQ, PQ) documentation
  • Acting as Senior QA officer 50% for 6 months 2005: Responsible for creating IT SOPs
  • ECTD: Supplier audit and QA responsible
  • ECTD: Supplier re-audit
  • Acting as QA officer 40% for 2 months 2006
  • 2 Supplier audits

 

Norwegian Computer Systems Supplier No. 1 2001
  • Seminar: Build in quality according to 21 CFR Part 11 and ISO 9000-3

 

Norwegian Pharmaceutical Company No. 7 2001

  • Internal audit of IT systems used for API production

 

British Laboratory Instruments Supplier No. 1 2002

  • 3 Seminars: 21 CFR Part 11, and Validation of computer systems

 

Norwegian Medical Device Company No. 2 2002-2003

  • LIMS: URS, SOPs, validation

 

Norwegian Governmental Accredited Laboratory No. 2 2002 – 2005

  • LIMS: URS, validation

 

Norwegian Medical Device Company No. 3 2002 – 2003

  • 21 CFR Part 11: Interpretation, checklist, system check
  • 21 CFR Part 11 inclusion of requirements in URS

 


Norwegian Pharmaceutical Producer and Supplier No. 1 2002-2004

Distribution system: Validation

 

GAMP Nordic 2002- now (in process)

  • Board member of GAMP Nordic, and Organizing committee and speaker at various meetings since 2002
  • Participating in Position Paper on Validation of Building Management Systems (2005)
  • Participating in project for updating GAMP 5 documents (2007)
  • Leader Special Interest Group for Supplier assessments and cooperation (2009)

 

US LIMS Supplier No. 1 2003

  • Key note speaker at Seminar: Corrective Action – Preventive Action
  • Report on functionality in LIMS versus SAP-QM

 

Norwegian Computer Systems Supplier No. 2 2003
  • Seminar: Build in quality according to 21 CFR Part 11 and ISO 9000-3
  • Assessment of their system for technical compliance with 21 CFR Part 11.

 

German Pharmaceutical Company No. 1 2003

  • LIMS: Supplier audit and project audit

 

Norwegian Computer Systems Supplier No. 3 2003 – 2006

  • Total Quality Management system

 

Norwegian Pharmaceutical Producer and Supplier No. 2 2003 – 2006

  • Specification of LIMS functionality in existing MRP system
  • Validation of MRP system

 

EU Leonardo da Vinci Project – Gent University, Belgium 2003 – 2006

  • Creating a curriculum for a Masters degree in IT validation. In charge of 4 graduate courses.

 

Icelandic Pharmaceutical Company No. 1 2003 – 2004

  • LIMS: Validation, SOPs

 

Norwegian / Belgian Chemical Company No. 1 2005

  • LIMS / PIMS: Assessment of documents, recommendations of global vs. local systems

 

Norwegian Pharmaceutical Supplier No. 3 2006

  • Supplier audit

 

Norwegian Oil Company No. 1 2006

  • LIMS / PIMS: User Requirements Specification for R&D

 

Belgian Pharmaceutical Company No.1 2006

  • LIMS: Independent reviewer of documents, presentation at project meeting

 

Danish Pharmaceutical Company No. 2 2006

  • Supplier audit

 

Ecoman, United Arab Emirates, May 2007

  • 5 day LIMS Class

 

Hospital, Norway 2007-2012 (in process)

  • Building Management System: Validation in new R&D Building
  • LIMS: User Requirements Specification, Validation plan, Implementation, IQ-OQ-PQ plan, testing and reports, Validation report in Department of Cellular Therapy

 

US/EU LIMS Supplier No. 2 2008

  • REACH Directive Report: Implications for LIMS

 

Norwegian Metal Industry No. 1 2008 – 2009

  • LIMS: User Requirements Specification and assessment of answers from the suppliers, Validation plan, Implementation

 

Swedish Oil Company No 1 2008 – 2009

  • LIMS: User Requirements Specification and assessment of supplier answers

 

Norwegian/Swiss Pharmaceutical Company No. 1 2009

  • Supplier audit: GCP supplier

 

Norwegian/Danish Logistics Company No. 1 2009-2012 – ongoing

  • Supplier audits: 2 GDP supplier audits
  • Warehouse Management System (WMS): Validation plan / report, User Requirements Specification, OQ/PQ plan / testing and report, 10 SOPs
  • WMS: New version revalidation

 

Norwegian Pharmaceutical Company No. 8 2009

  • Supplier audits: 3 GCP supplier audits

 

Hogeschool Gent, Belgium, Academic year 2010-2012 (Ongoing)

  • Teaching class for Master’s degree “Quality Management Systems” (Curriculum created for the Leonardo da Vinci project, see above). 2010-2011
  • Teaching class for Master’s degree “Quality Management Systems – Validation” (Curriculum created for the Leonardo da Vinci project, see above). 2012

 

Ecoman, United Arab Emirates, October 2010

  • 5 day ISO 17025 Class (Laboratory Accreditation standard)

 

Latvian pharmaceutical company, 2011-2012

  • 1-day class on What is LIMS?
  • LIMS: User Requirements Specification

 

Veterinary University, Norway, 2011-2012

  • 2 day class: How to handle LIMS within the ISO 17025 accreditation standard
  • Internal audit if implemented LIMS

 

Danish Pharmaceutical company No 3 2011

  • LIMS Validation: Internal audit of validation documents

 

Ecoman, Malaysia, 2012

  • 5 day LIMS Class

 

US Pharma Supplier No. 1 2013

  • 21 CFR Part 11: SOP reviews

 

Open Class Norway, 2013 and 2014:

  • How to Handle IT Systems in a Paperless Laboratory

 

Norwegian Pharmaceutical company No.9 , 2013

  • Training for their employees 2013: Validation of IT systems according to GAMP5

 

Norwegian Pharmaceutical Company No. 4 2001 and 2014 (current)
·           Documentation system: Supplier audit in 2001
·           Documentation system: 21 CFR 11 Assessment of the documentation system, and Supplier audit in 2014

 

Norwegian Research Organization No. 1, 2014 (current)

  • LIMS: URS, assessment of suppliers, validation

 

Finnish LIMS Supplier No. 1 2001-2002, 2005, and 2014 (current)

  • Seminar for their user group 2001: Validation of LIMS, requirements according to various standards
  • Review of their LIMS system and service: Assessment according to 21 CFR Part 11, GMP and ISO 17025
  • 2 Seminars for their user groups 2002: Electronic signatures and electronic records
  • 1 seminar for their user group 2005: Validation of IT systems

Norwegian Pharmaceutical Company No. 8 2009 (ongoing)
• Supplier audit: GCP supplier.

Norwegian/Danish Logistics Company No. 1 2009 (ongoing)
• Supplier audit: GDP supplier
• WMS system: Validation plan, User Requirements Specification, OQ/PQ plan and report, SOPs.
Norwegian/Swiss Pharmaceutical Company No. 1 2009
• Supplier audit: GCP supplier.
Swedish Oil Company No 1 2008 – 2009 (ongoing)
• LIMS: User Requirements Specification and assessment of supplier answers.
Norwegian Metal Industry No. 1 2008 – 2009 (ongoing)
• LIMS: User Requirements Specification and assessment of answers from the suppliers, Validation plan, Implementation.
US/EU LIMS Supplier No. 2 2008
• REACH Directive Report: Implications for LIMS.
Hospital, Norway 2007 – 2009 (ongoing)
• Building Management System: Validation in new R&D Building.
• LIMS: User Requirements Specification, Validation plan, Implementation, IQ-OQ-PQ plan, testing and reports, Validation report in Department of Cellular Therapy.
Hogeschool Gent, Belgium, Academic year 2008 – 2009
• Teaching classes for Master’s degree One class on Quality Management Systems and one class on IT Systems Validation (Curriculum created for the Leonardo da Vinci project, see above). Teaching will start provided sufficient students.
Ecoman, United Arab Emirates, May 2007
• 5-day LIMS Class.
Danish Pharmaceutical Company No. 2 2006
• Supplier audit.
Belgian Pharmaceutical Company No.1 2006
• LIMS: Independent reviewer of documents, presentation at project meeting.
Norwegian Oil Company No. 1 2006
• LIMS / PIMS: User Requirements Specification for R&D.
Norwegian Pharmaceutical Supplier No. 3 2006
• Supplier audit.
Norwegian / Belgian Chemical Company No. 1 2005
• LIMS / PIMS: Assessment of documents, recommendations of global vs. local systems.
Icelandic Pharmaceutical Company No. 1 2003 – 2004
• LIMS: Validation, SOPs.
EU Leonardo da Vinci Project – Gent University, Belgium 2003 – 2006
• Creating a curriculum for a Masters degree in IT validation. In charge of four graduate courses.
Norwegian Pharmaceutical Producer and Supplier No. 2 2003 – 2006
• Specification of LIMS functionality in existing MRP system
• Validation of MRP system.
Norwegian Computer Systems Supplier No. 3 2003 – 2006
• Total Quality Management system.
German Pharmaceutical Company No. 1 2003
• LIMS: Supplier audit and project audit.
Norwegian Computer Systems Supplier No. 2 2003
• Seminar: Build in quality according to 21 CFR Part 11 and ISO 9000-3.
• Assessment of their system for technical compliance with 21 CFR Part 11.
US LIMS Supplier No. 1 2003
• Key note speaker at Seminar: Corrective Action – Preventive Action.
• Report on functionality in LIMS versus SAP-QM.
GAMP Nordic 2002 today (ongoing)
• Board member of GAMP Nordic, and Organizing committee and speaker at various meetings since 2002.
• Participating in Position Paper on Validation of Building Management Systems (2005).
• Participating in project for updating GAMP 5 documents (2007).
• Leader Special Interest Group for Supplier assessments and cooperation (2009).
Norwegian Pharmaceutical Producer and Supplier No. 1 2002 – 2004
Distribution system: Validation.
Norwegian Medical Device Company No. 3 2002 – 2003
• 21 CFR Part 11: Interpretation, checklist, system check.
• 21 CFR Part 11 inclusion of requirements in URS.
Norwegian Governmental Accredited Laboratory No. 2 2002 – 2005
• LIMS: URS, validation.
Norwegian Medical Device Company No. 2 2002 – 2003
• LIMS: URS, SOPs, validation.
British Laboratory Instruments Supplier No. 1 2002
• Three Seminars: 21 CFR Part 11, and Validation of computer systems.
Norwegian Pharmaceutical Company No. 7 2001
• Internal audit of IT systems used for API production.
Norwegian Computer Systems Supplier No. 1 2001
• Seminar: Build in quality according to 21 CFR Part 11 and ISO 9000-3.
Norwegian Pharmaceutical Company No. 6 2001 – 2006
• QA system top level: SOPs for IT systems, plus review and rewriting later on risk-based approach.
• Acting as QA manager for IT systems for 1 month 2003.
• Document Management system: SOPs and 21CFR11 status and test plans.
• SAP rollout: Review of validation (IQ, OQ, PQ) documentation.
• Acting as Senior QA officer 50% for 6 months 2005: Responsible for creating IT SOPs.
• ECTD: Supplier audit and QA responsible.
• ECTD: Supplier re-audit.
• Acting as QA officer 40% for 2 months 2006.
• Two Supplier audits.
Norwegian Pharmaceutical Company No. 5 2001
• MRP system: Supplier audit.
• Internal audit of IT systems and their handling according to GMP, 21 CFR Part 11 and internal quality system.
Norwegian Medical Device Company No. 1 2001
• Medical device: OQ/PQ plan, testing and report.
Norwegian Pharmaceutical Company No. 4 2001
• Documentation system: Supplier audit.
Swiss Pharmaceutical Company No. 1 2001 – 2002
• Chromatography system: Supplier audit.
• LIMS system: Supplier audit, OQ protocol / plans.
• MRP system: Supplier audit.
Open Classes Finland 2001
• 21 CFR Part 11: Interpretation of the regulations, and practical implementation.
• Validation of IT system: Which activities are included, and how to handle them.
Open Classes Norway 2001
• 21 CFR Part 11: Interpretation of the regulations, and practical implementation.
• Validation of IT system: Which activities are included, and how to handle them.
Finnish LIMS Supplier No. 1 2001 – 2002 and 2005
• Seminar for their user group 2001: Validation of LIMS, requirements according to various standards.
• Review of their LIMS system and service: Assessment according to 21 CFR Part 11, GMP and ISO 17025.
• 2 Seminars for their user groups 2002: Electronic signatures and electronic records
• 1 seminar for their user group 2005: Validation of IT systems.
Norwegian Pharmaceutical Company No. 3 2001 – 2003
• Short seminar: 21 CFR Part 11.
• Class for 100 employees: 21 CFR Part 11.
• Workshop: LIMS validation, status and plans.
• 2 day workshop: validation of computer systems used in production and laboratories, special emphasis on instruments.
• Maintenance software: Validation.
Swedish Medical Device Company No. 2 2000 – 2002
• Seminar: LIMS project and system validation.
• LIMS: URS, assessment of Supplier answers, Supplier audit, leading the validation process.
• Class: LIMS validation, 21 CFR 11 and GMP requirements.
Swedish Pharmaceutical Company No. 2 1995 – 98
• Computer Systems Validation Handbook: Reviewed and suggested corrections.
• LIMS: Supplier audit, co-project leader for implementation, responsible for SOPs and validation.
• Clinical system 1: Supplier audit, SOPs, validation.
• Clinical system 2: Retrospective validation. Supplier audit.
• Chromatography system: Prospective and retrospective validation. Supplier audit.
• One-day seminar: Quality assuring the IT systems according to GMP and GLP.
• Internal audits of several types of IT systems’ validation protocols, validation documentation and reports.
Norwegian Pharmaceutical Company No. 2 2000
• Seminar: LIMS project and system validation.
• LIMS: Quality/validation plan.
Norwegian Pharmaceutical Company No. 1 1999 – 2001
• LIMS: Feasibility study.
• MRP: URS, Supplier audit.
Norwegian Accreditation 1998
• Seminar: Year 2000 problem in the accredited laboratory.
Norwegian Governmental Agency No. 1 1998 – 1999
• Seminar: Validation of LIMS in the EN 45001 accredited environment.
• LIMS: implementation, validation, Standard operating procedures (SOP).
Danish Pharmaceutical Company No. 1 1998 – 2003
• LIMS Project team member with 50% time for nearly 2 years: URS, in-house test plans, quality/validation plan, Supplier selection, SOPs, system validation, implementation & qualification of static data in system.
• 3 Seminars: 21 CFR Part 11 & Validation of LIMS, tailored to the company’s internal requirements and the chosen LIMS.
• Toxicology LIMS: URS, assessing Supplier answers to URS, validation plan.
• Drug analysis LIMS: Assessing documentation.
• 21 CFR Part 11 project: Checklists, class, assessment of approx. 30 systems with action suggestions.
• Batch documentation management system: Validation plan.
Norwegian Pharmaceutical Raw Material Company No. 1 1997 – 98 and 2000 – 2001
• Seminar: Validation of computer systems.
• SAP: Supplier audit.
• LIMS: URS, in-house test plan, Supplier audits.
Swedish Pharmaceutical Company No. 5 1997 – 98
• LIMS: Assessment of Supplier replies to URS, Supplier audit, validation and SOPs.
• Two-day seminar: Validation of LIMS in the pharmaceutical industry.
Swedish Pharmaceutical Company No. 4 1997 – 98
• LIMS: Implementation, validation, SOPs.
Swedish Medical Device Company No. 1 1996 – 99
• 2 x one-day seminar: Quality assuring the lab computer, and what standards to apply in this industry.
• Two short seminars: What is LIMS, and Quality Assurance for an IT department.
• LIMS: 2 Supplier audits, implementation, validation, SOPs.
Swedish Pharmaceutical Company No. 3 1995 – 96
• Chromatography system: System validation and SOPs, 3 Supplier audits.
Swedish Pharmaceutical Company No. 1 1995
• LIMS: Written User Requirements Specification (URS) for a new LIMS.
Royal Pharmaceutical Society of Great Britain 1995, 1996, and 1997
• Teaching team for 3-day classes in “Practical Computer Validation.”
Norwegian Chemical Supplier No. 1 1995 and Norwegian Chemical Supplier No. 2 1996
• Total quality management system: Written all parts of the TQM comprising quality manual and SOPs, covering all aspects of quality of products and service, and legal requirements from the Working Environments Act.