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.
What can I do in your organization?
I can help you
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Suggesting changes to your workflow
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Writing your user requirements specification
( URS ) or Request For Proposal (RFP)
for your new computer system
-
Assessing the
answers to the URS / RPF from the vendors
-
Auditing the vendor
or your suppliers for built-in quality of research work or
computer systems
-
Writing Standard Operating Procedures (
SOPs ) for your new or old system
-
Writing validation
protocols and test plans
-
Writing validation reports
-
Auditing the work you have done
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Tailoring training to your organizational
needs (validation, LIMS, project management, 21 CFR Part 11,
vendor audits, risk management, just to name a few)
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Implementing your LIMS
-
Setting up a good organization
for managing your computer systems
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Creating your internal standard for handling
computer systems
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Creating your Total Quality Management System
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21 CFR Part 11
assessments of current and future systems, including plans
for how to get non-compliant systems closer to compliance
-
.... and other things along these lines
Practice
-
Years of working experience of Laboratory
Information Management Systems (LIMS),
chromatography systems and laboratory chemistry
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Invited guest speaker to more than a dozen
countries in three continents
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Many publications
in internationally renowned professional journals
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Long CV
Computerized systems
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21 CFR Part 11 (electronic records and electronic
signatures)
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Computer system implementation and management
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All parts of life cycle validation of computerized
systems
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Experience with several types of:
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Laboratory Information Management Systems
(LIMS)
-
Chromatography systems
-
Instruments
-
MRP / SAP
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Document management systems
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Clinical systems
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Drug analysis systems
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Toxicology systems
Quality management
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In-depth knowledge of Quality Assurance (QA)
systems and standards
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Applied quality assurance of computerized
systems, laboratories and production
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Total Quality Management (TQM)
Languages
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Proficiency in English and Norwegian
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Full communication capability of Swedish
and Danish
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Understanding knowledge of German
My Network
I also have contact with other consultants who
might work with me on larger projects. These also form my network,
and I can contact them if I need to discuss problems. These are
specialists on:
-
21 CFR Part 11
-
MRP systems
-
Instrument qualifications
-
IT system validation
-
Health / environment / security (HES / HMS)
requirements for industry
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ISO 9000 quality assurance systems
-
ISO 17025 lab accreditation
Want to know more?
