Services

Segalstad Consulting can help you:

• Suggest changes to your work flow.
• Write your User Requirements Specification (URS) or Request For Proposal (RFP) for your new computer system.
• Assess vendor answers to the URS / RPF.
• Audit your vendor and/or suppliers for built-in quality of research or computer systems.
• Write Standard Operating Procedures (SOPs) for your new or old system.
• Write validation protocols and test plans.
• Write validation reports.
• Audit the work you have done, such as your validation documents, your SOPs, your User Requirements Specification (URS).
• Tailor training to your organizational needs (validation, LIMS, project management, 21 CFR Part 11, supplier audits, risk management, and much more.)
• Implement your Laboratory Information Management System (LIMS).
• Set up a good organization for managing your computer systems.
• Create your internal standard for handling computer systems.
• Create your Total Quality Management System.
• 21 CFR Part 11 assessments of current and future systems, including plans for how to get non-compliant systems closer to compliance.
…. and much more.

Segalstad Consulting offers expertise with several types of:
• Laboratory Information Management Systems (LIMS)
• Chromatography systems (CDS)
• Instruments
• MRP / SAP
• Document management systems
• Clinical systems (GCP)
• Other GMP and GLP systems
• Production systems
• Logistics systems
• Drug analysis systems
• Toxicology systems
• In-depth knowledge of Quality Assurance (QA) systems and standards like ISO 17025, ISO 9000 serier, GAMP, GLP, GCP, GAMP, GALP, etc.
• Applied quality assurance of computerized systems, laboratories and production

 

My Network
I also have working relationships with other consultants who sometimes involve in larger projects.

Why do you need a consultant?
Having an external consultant actually pays: You use an expert who does not have to learn while you are paying; whose expertise is already available when you need it now; and who has time to concentrate on getting the specific job done. You have no more employer responsibilities when the work is finished. I will work with you so you learn along the way and may be able to do it yourself the next time.