Sanyo Validation - Manual (Page 2)

As a leader in commercial, refrigeration,
energy and environmental products,
sANyO offers a robust source of proven
technologies and technical services
deployed throughout a range of
biomedical and medical research
products.
Pioneering developments in consumer
and industrial products are applied to
all sANyO products through the devel-
opment model of Vertical Component
Integration™. Because many of our
key component parts are designed and
built by sANyO, we offer only the most
precise and in-depth validation resources
specific to sANyO laboratory products.
Detailed Validation Support Package
sanyo also offers detailed protocols in-
cluding all required specifications manu-
als and support documents. This package
will assist your validation team in the
qualification process, greatly reducing
the time required to complete the entire
validation.
sanyo validation systems are calibrated
and maintained to the highest quality
standards, while providing and retaining
detailed records for all tested equipment.
As the manufacturer we are the most
knowledgeable on our equipment. We
offer validation services for sanyo equip-
ment and a total solution in fulfilling
other regulatory requirement.
v a l i d a t i o n
VALIDATION
sanyo provides a thermal validation
solution specifically designed to conform
with new fDA data protection guidelines
(21 Cfr Part 11) and meet international
and European cGMP requirements for
inspection of pharmaceutical, biotechnol-
ogy and medical device (EN285, EN554)
manufacturing. sanyo simplifies the entire
validation process by reducing setup time
and minimizing sensor handling, automat-
ing sensor calibration, systematically
organizing study data and generating
required regulatory reports.
sanyo implements a wired process
validation system designed around the
measurement and reporting requirements
of the most intensely regulated industries.
Our system meets the standards for cGMP
regulated industries for thermal validation
and has broad regulatory compliance.
We offer a complete package of thermal
management including simulations and
measurement:
• Measurement of temperature profiles
• Data analysis
• System design
Turn Key Solutions available for:
• Ultra low freezers
• Cryogenic freezers
• Pharmaceutical refrigerators
• Incubators
• Autoclaves
sanyo can assist throughout the entire
process from helping you to choose your
equipment through the extended war-
ranty and service contract options to keep
your equipment running. We help you
match the appropriate equipment to your
requirements (Dq) as well as arranging
inside delivery and setup (commissioning)
of the equipment.
In addition, sanyo can perform the onsite
qualification of your equipment (Iq/Oq/
Pq); Iq documents the proper installation
of the equipment, Pq documents proper
operation of the equipment as specified
by sanyo or other manufacturers, and Pq
documents proper performance of the
equipment as you will use it.
We offer in depth factory acceptance
testing covering alarms as well as tem-
perature/CO2 stability and recovery. This
service can also be customized to your
sOPs.
VALIDATION SOLUTIONS THERMAL VALIDATION
User Requirement
Manufacturer specs
DQ(choose equipment)
Commissioning
O
Q
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ifi es
M
an
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P
Q
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IQ
V
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ifi es
P
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et
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IQ / OQ / PQ
FACTORY ACCEPTANCE