Ausnutria is a high
grade food manufacturer of infant food. The company produces milk powder from
cow and goat milk for the Asian and American market. For the analyses of
samples the services of an external party are used. Data exchange between the
Ausnutria SAP QM system and the LIMS of the external analytical service
provider is done by a custom build interface. Yxion was hired for the
validation of this interface.
I was deployed at
Ausnutria for the creation of a validation package for the interface. For this
I used the GAMP5 guidelines of ISPE. I approached the project in four phases.
First, I did assessments to establish the validation scalability. Then, I wrote
the validation plan and the test plan. Subsequently the documents belonging to
the left side of the V-model – URS, FRS and DS were created. Finally, the
qualification test protocols IQ and a combined OQ and PQ have been written.
Testing was done by
the Ausnutria employees whereby I assumed the role of test coach during the
testing phase. After the testing was completed, I wrote the validation summary
report and the traceability matrix.
Ausnutria is an
organisation that requires a lot of coaching where validation of computerized
systems is concerned. This is a role I take much pleasure in.
As more systems needed to be validated, I also took
upon me the task of writing the validation project plans. These served as an
offer from Yxion to Ausnutria for the second phase of this validation project.
In April 2020 Ausnutria was still evaluating the way forward in the validation
trajectory.
Sanquin Plasma
Products produces blood plasma products for pharmaceutical application in
hospitals. Currently, they are implementing a new LIMS. This is done in phases,
the first phase being the implementation with the incoming goods department.
I was hired as LIMS
consultant to support the implementation team. My main activities consist of
writing the functional and process test scripts for the SAP-LIMS interface and
the customisations that are being implemented.
Other activity are the implementation and validation
of R232 instrument interfaces and the setup of user roles in the system.
Philips Healthcare
has several document management systems that need validation. I participated in
the team in Eindhoven that was validating the document information management
system called DIM.
I acted as CSV engineer writing and executing
process tests. We worked together with teams in India and the United States. I
wrote some 20 test scripts and supported the execution of the tests in the test
teams.
Galapagos is a pharmaceutical biotech company
that focusses on the development of drugs through target discovery. The
medicinal chemistry departments in Mechelen (Belgium) and Romainville (Paris,
France) required an ELN for the registration of their drug discovery Process.
As a Business Analyst I gathered the user
requirements of the ELN in workshops with stakeholders for the chemistry and
Quality departments. For the package selection, we approached 8 suppliers from
which finally 2 were selected for a live demonstration workshop. This resulted
in the selection of the Biovia Workbook from Dassault Systems.
After the package selection I acted as
business project manager for the implementation of the product. In this
capacity I worked together with the supplier project manager who directed the
supplier processes.
In
addition, I acted as business analyst for the implementation of changes in the
LIMS system that was a proprietary build LIMS. In this capacity I was the
linking pin between the business and the Information Systems department that
was located in Mechelen.
Corbion produces a wide variety of lactic acid
products and applications in which lactic acid is used. The company has a large
R&D department in which new products and lactic acid applications are being
developed. The R&D process needs modernisation and Atos was called in to
support the process of package selection.
I
had the role of business and information analyst in this project. I
investigated the workflows in the different departments and held workshops with
SME’s to gather user requirements (URS). These user requirements were used to
select the most fitting systems to support the daily business in the R&D
departments. I documented my findings in Word and Visio.
Atos provided an authentication service to
Philips Healthcare. As a regulated company, Philips Healthcare required the
authentication service to be validated.
I was deployed on the validation project for
the creation of a package of documents. I executed a quality system impact
analysis and a 21 CFR part 11 assessment. This revealed the level of validation
necessary.
A
user requirements (URS) document was created and the corresponding performance
qualification was drawn up. In addition a configuration document was created
and from this the installation and operation qualification was written.
created with
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