LIMS Consultants


Siri Segalstad
Segalstad Consulting AS
P.O. Box 15 Kjelsaas
N-0411 Oslo
NORWAY
Phone: +47 2223 8005
Fax: +47 2223 8581
Email: siri@segalstad.com
Web: http://www.limsconsultant.com


Segalstad Consulting specializes in all aspects of validation of computer systems, with emphasis on LIMS. Siri has extensive knowledge of quality standards like Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP), 21 CFR Part 11, and relevant standards like Lab Accreditation (ISO 17025), and other standards from ASTM, IEEE, ISO. Siri has passes her TickIT auditor exam for ISO 9000-3, which utilizes the ISO 9000-3 guideline for developing and manufacturing computer programs. She is also an approved auditor for Norwegian Accreditation.

Siri has experience with LIMS and validation since 1987, and started her own consultancy in 1995. She works mainly in the highly regulated pharmaceutical / medical device industry, but is also involved in other industry and in accredited laboratories and testing labs.

Please see the web page www.limsconsultant.com for more information.

Services offered:

Overall Validation:
Validation Master Plans, including definitions of the various qualifications, and report; Policies, quality manual and top level procedures including 21 CFR Part 11 requirements for computerized system; Audit of what has already been done

Development Qualification - DQ:
Writing User Requirements Specifications; Assessing vendor answers; Vendor audits

Installation Qualification ­p; IQ:
IQ plans and reports for installation of hardware and software

Operation Qualification ­p; OQ:
OQ plan including all the test plans needed for the system in question, testing and report

Performance / Process Qualification ­p; PQ:
PQ plan, testing and report

Standard Operating Procedures (SOPs), including change control and all other necessary procedures for the system

Training tailored to the organizations needs:
CR Part 11; Validation; Qualifications of computer systems and instruments; Vendor audits

21 CFR Part 11 (electronic records and electronic signatures)
Policy; Guidelines; SOPs; Interpretation; Training; Checklists; Assessment of systems, including suggestions for how to get into compliance, and reports

LIMS Consultants | LIMS Products & Services | LIMSource Contents | Home