Segalstad Consulting AS
| Question | Vendor Response |
| Company Name | Segalstad Consulting AS |
| Street Address | |
| Post Office Box | P.O. Box 15 Kjelsas |
| City | N-0411 Oslo |
| State/Region | |
| Country | Norway |
| Mail Code | N-0411 |
| Phone Number | +47 2223 8005 |
| Toll-free Phone Number | N/A |
| FAX Number | +47 2223 8581 |
| Web Site URL | www.limsconsultant.com |
| Contact Name for Inquiries | Siri H. Segalstad |
| E-mail Address for Inquiries | siri@segalstad.com |
| Names of Principals (Separate multiple names with semicolons) | Siri H. Segalstad |
| Languages Supported (e.g. English, Esperanto, German, Russian, Spanish, etc.) |
English: Proficiency oral and writing Norwegian: Proficiency oral and writing German: Understanding knowledge Danish: Reading, understanding, and communication knowledge Swedish: Reading, understanding, and communication knowledge |
| Geographic Areas Supported | Any |
| Total Company Staff Size | 1 person, but with a large network facilitating possible expansion of personnel for job that need more persons. |
| Brief descriptive synopsis of company |
VALIDATION: Specializing in all aspects of validation of IT systems: Writing User Requirements Specifications (URS) and assessing vendor answers, validation plans and reports, DQ / OQ / PQ plans, testing and reports, Standard Operating Procedures (SOPs). Internal and vendor audits. Both for developers of systems (based on ISO 9000-3 / GAMP / IEEE / ASTM) and for end-users of systems. TRAINING: Will give formal and on-the-job training on validation, 21 CFR Part 11, LIMS, tailored to the client’s needs. STANDARDS: Knowledge, applicability, and use of external standards for pharmaceutical industry (GMP / GLP / GCP / 21 CFR Part 11 / GAMP), and other industries (Lab accreditation, ISO, ASTM, IEEE, GALP, etc.) LIMS: Large knowledge of LIMS systems and vendors. |
| Question | Vendor Response |
| Application Packages Supported | Any |
| Chromatography Data Systems | Any |
| Databases | Any |
| Development Languages/Tools | |
| Document Management Systems | Any |
| Enterprise Computing Applications | Any |
| LIMS/LIS | Any |
| Report Generation/Design Tools |
