quality assurance lims with Segalstad Consulting
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Do you need a class?

Your company may have specific requirements, your own project or your own internal procedures which need to be included in the class to make it more useful for you. Segalstad Consulting AS can tailor a class to your needs and incorporate your requirements. We can plan the class together, and make it just the way you need it. Below are some examples of classes that have been given, but any class can be discussed. We have contacts that may add their specialties if we do not have the knowledge ouselves.

The classes are of course tailored to the target audience. They may be given as presentations, or as workshops where the goal is to get the framework be done.

Examples of classes given in companies or as open classes 

Validation of computer systems in general

  • Including requirements for the external standards that the company uses (GMP / GLP / GCP / 21 CFR 11 / GAMP / ISO 17025, etc.)

  • Including requriements from their internal standards (policies / quality manual / SOPs, etc.)

Validation of the company's chosen system, for example LIMS

  • Including requirements for the external standards that the company uses (GMP / GLP / GCP / 21 CFR 11 / GAMP / ISO 17025, etc.)

  • Including requriements from their internal standards (policies / quality manual / SOPs, etc.)

  • Including their implementation / validation plan etc.

21 CFR Part 11

  • Understanding 21 CFR Part 11 requirements

  • Technical requirements

  • Validation requirements

  • Practical implementation

  • 21 CFR 11 Project

  • Creating checklists for compliance

  • Assessing systems for compliance

LIMS

  • Understanding LIMS

  • LIMS Project and system validation

Classes for suppliers and other programmers

  • Build in quality according to 21 CFR Part 11 and ISO 90003

Supplier audits

  • Requirements in ISO 90003 / GAMP

  • Planning and performing the audit

  • Receiving the audit

Including IT systems in the Quality Management System (QMS)

  • How to create a Quality Management System

  • How to include IT systems in the QMS

  • Procedures for the IT systems

 

Want to know more?

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Segalstad Consulting AS
PO Box 15 Kjelsås, 0411 Oslo, Norway * Tel: +47 2223 8005 * Fax: +47 2223 8581 * Email: Siri@Segalstad.com * 

Web: www.LIMSconsultant.com    www.segalstad.com