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PI Project & Omni

Maintenance
Chapter

Norman Su, SFSU


Technical Publications
August 2017

1 Cepheid
© © Cepheid
Package Insert Project Background

• Package Inserts (PI) are used to describe


proper use of the product as well as
provide supporting data for every test.
• Guanidinium Thiocyanate (GTC) is in
about 75% of all assays.
• Competitors say GTC is harmful for the
environment.
• Cepheid conducts lab study to prove the
amount of GTC remaining is negligible.
• All Safety Data Sheets (SDS) need to be
updated for change.
• All related PI need to be updated
according to their relevant SDS.
2 © Cepheid
Package Insert Project Milestones and Actions

• Participated in meetings between


other departments regarding
changes.
• Inserted/Updated the Chemical
Hazard section according the
latest Safety Data Sheet (SDS).
• Updated old formatting and
language while making changes
to Chemical Hazard Sections.
• Updated and translated
screenshots using GeneXpert
and Photoshop.
• Submitted updated files for
translation.
3 © Cepheid
Package Insert Project Results

• Edited and updated 19 package


inserts
• Depending on the package insert,
they can be on different stages.
• Most package inserts are waiting
on updated safety data sheets
(SDS), others on .gxx files.
• 4/19 (21%) of all package inserts
are finished (complete SDS and
SS).

4 © Cepheid
Omni Maintenance Manual Project Background

• Technical Publications needs to provide


complete documentation for Omni
• First draft of the maintenance section
was written earlier this summer.
• As the Omni and its software changed,
the maintenance section was constantly
becoming outdated.
• I was responsible for making sure the
procedure matched what the customer
saw.
• As the Omni and its software continues
to change, this revision would not be
the last.
5 © Cepheid
Omni Maintenance Chapter Milestones and
Actions

• Went through outdated


instructions step-by-step with
Omni and mobile device to see
what was outdated.
• Rewrote instructions and updated
screenshots when necessary.
• Updated outdated icons within
the manual to reflect current
software

6 © Cepheid
Project Impacts

• Updating package inserts allows customers to have the


latest information within their product.
• Competitors cannot use GTC against Cepheid while
seeking for new customers.
• In case of FDA audits, all our information will be up to
date.

• Having the latest revision of the Omni manual will help if


we need to know how the software worked previously.
• Going through the manual step by step showcases areas
that need to be improved upon

7 © Cepheid
Summer in Review

The Great If I had more time…


• Got to have a hand in original • Wasn’t able to get into more
writing complex publication tools like
those used in DITA authoring.
• Experience with programs that I
wouldn’t use otherwise • Wasn’t able to see a lot of my
work being pushed through to
• Ability to attend meetings with the end.
other departments for a well
rounded understanding of the • More lunch and learns, or just
company intern sessions that explained
the roles within the company

8 © Cepheid
Takeaways

• Work done this summer was


very relatable for what I’m
learning/working on in school.
• Allowed me to learn multiple
parts of the publication
process.
• Learned to pay attention to the
little things. To take it slow and
get it right the first time.
• I am now more curious to see
how technical publications is
used in different industries.

9 © Cepheid
Thank You.
Visit us at www.cepheid.com

10 © Cepheid

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