Published Works

Bibliography of Siri H. Segalstad’s published books, chapters, and scientific articles and papers

Segalstad: International IT Regulations and Compliance, Book 344 pages, ISBN 978-0-470-75882-3, Wiley-Blackwell, October 2008.

Segalstad, Kierulf, Langseth-Manrique, and Storstein: Free Digitoxin in Normal and Albumin-Deficient Serum as estimated by Centrifugal Ultrafiltration, Clinical Chemistry 4 (1988) 766-777.

Segalstad and Synnevåg: A practical guide to validating LIMS, Laboratory Information Management 26 (1994) 1-12 (Tutorial).

Segalstad: Quality Assurance of Computer Systems What is needed to comply with ISO 9000, GMP, GLP, and GCP?, Laboratory Automation and Information Management 31 (1995) 11-24.
Segalstad: Quality Assurance of Computer Systems Compliance with GMP, GLP, GCP and ISO Standards, LIMS Letter Vol II – Issue I, Spring 1996.

Segalstad: LIMS 95 – LIMS 1995 – A delegate’s view, Laboratory Automation and Information Management 31 (1995) 151-153.

Segalstad: Vendor audits for Computer Systems: An ISO 9000-3 approach, Laboratory Automation and Information Management 32 (1996) 23-31.

Segalstad: Validation of computer databases for GxP. Chapter in book Good Research Practices, edited by Nigel Dent, Butterworth and Heineman (1996) 475-485.

Segalstad: Book review, Laboratory Automation and Information Management, 1996.

Segalstad: Supplier Auditing and Software, European Pharmaceutical Review Vol. 1 Issue 3, (1996) 37-44.

Segalstad: Quality Assuring the Laboratory Computer – keeping it in compliance. Proceedings from 18th Nordic Conference on Measuring Techniques, November 1996.

Segalstad: Outsourcing work in the pharmaceutical industry – a challenge to quality, European Pharmaceutical Review Vol.1 Issue 4, (1996) 59-63.

Segalstad: Validation Issues Update, LIMS/Letter Spring 1997, 6-7.

Segalstad: Can You Rely on Your Information Technology, Inside Laboratory Management, Vol. 1 No. 4 (May 1997) 16-17.

Segalstad: Kvalitetssikring av laboratorier – Ufullstendig uten validering av IT-systemer. (Quality assurance of laboratories – incomplete without validation of IT systems), Kjemi 8, 1997, 16-18.

Segalstad: Software validation according to EU GMP Annex 11, European Pharmaceutical Review, Vol. 2 Issue 4, (1997) 55-64.

Segalstad, Florén, Nilsson: Choosing and installing the right LIMS, Scientific Computing World, Issue 39 June 1998, 25-26. (Re-written by the journal’s editor without authors’ approvals)

Segalstad: År 2000-problemet: Datakaos slett ikke umulig (Year 2000: Data chaos not inconceivable), Kjemi 6, 1998, 11.

Segalstad: LIMS: M is for Management, Process Information Technology, June 2000 54-56.

Segalstad: The WWW (Who-Why-What) of 21 CFR Part 11 Electronic Records and Electronic Signatures, European Pharmaceutical Review Vol. 5 Issue 2 (2000) 69-74.

Segalstad: The User Requirements Specification – The most Important Tool in the Validation, Scientific Computing and Instrumentation, Fall 2000 (24-25)

Segalstad: Development Qualification: Selecting the right LIMS vendor, European Pharmaceutical Review, Vol. 5 Issue 4 (2000) 58-61 se tekst logo for journals Also published in:
American Pharmaceutical Review, Vol. 3, Issue 4 Winter 2000-2001 (84-87)

Segalstad: Instrument validation, Managing the Modern Laboratory Vol.5 No.3 2001 (57-61)

Segalstad: Elektroniske data og elektronisk signatur, (electronic data and electronic signatures) Kjemi, April 2001 (9-12)

Segalstad: Arvelighet av pelsfarver hos collie (Heredity of fur colors in the collie dog), Norsk Collieblad No.1, 2002 (60-64). Also revised and published in “Compendium for judging the collie”, Norwegian Collie Association, 2002.

Segalstad: How to use and misuse a consultant, Scientific Computing LIMS Issue January 2003 (14-19)

Segalstad: Testing for technical compliance with 21 CFR Part 11, International Validation Technology, August 2004 (342-350)

Segalstad: Laboratory Information Management Systems – LIMS, 5000 words in Marcel Dekker’s Online encyclopedia, Marcel Dekker Publisher, Contracted paper 2004

Segalstad: Risikovurdering og risikohåndtering (Risk assessment and risk management), Kjemi 4, 2004

Segalstad: Hvilken LIMS skal vi velge? (Which LIMS shall we choose?) Kjemi 7, September 2004 (10-14)

Segalstad: Contributor to GAMP Special Interest Group position paper: Use of Building Management Systems and Environmental Monitoring Systems in Regulated Environments, Pharmaceutical Engineering, September / October 2005 (28-78)

Segalstad: Pharmaceutical Standards for Computerized Systems. ISPE Pharmaceutical Engineering March-April 2007 (94-101)

Segalstad: Contributor to GAMP5 chapter on Testing, 2008

Segalstad: Standards for LIMS. Scientific Computing and Instrumentation January 2007 (1-2 and 19-24)

Segalstad: International IT Regulations and Compliance, Book 344 pages, ISBN 978-0-470-75882-3, Wiley-Blackwell, October 2008.

Segalstad: The Many Ways of Implementing LIMS But are some Ways better than Others? American Pharmaceutical Review, February 2009 (28-31)

Segalstad: Which LIMS is the best? Scientific Computing and Instrumentation May 7 June 2009 (6-8)

Segalstad: Do we really understand risks? Scientific Computing and Instrumentation. July 2009

Segalstad: Quality Assurance and Quality Control. Scientific Computing and Instrumentation. July 2009

Segalstad: Use of consultants. Scientific Computing and Instrumentation. July 2009.

Segalstad: IT Supplier Audits for the Regulated Industries, Computer Validation Digest. July 2009

Segalstad: Instrument qualification, Scientific Computing and Instrumentation. July 2009.