Sanyo Validation User Manual

Validation Services

COMPLETE VALIDATION & QUALIFICATION SERVICES

(TURN KEY SOLUTIONS)

v a l i d a t i o n

SEAMLESS INTEGRATION OF VALIDATION
& TECHINICAL SUPPORT

ULTRA LOW FREEZERS
CRYOGENIC FREEZERS
PHARMACEUTICAL REFRIGERATORS
INCUBATORS
AUTOCLAVES

Validation &
Qualification
Solutions for
laboratory equipment

SANYO is a vertical component

manufacturer that can provide turn-key
solutions for validation and qualification in
accordance with all current GMPs, GLPs, GCPs,
21 CFR Part 11, PAT, ISO and specific customer
requirements and applications. Because many
of our key component parts are designed and
built by SANYO, we offer the most precise and
in-depth validation resources specific to
SANYO laboratory products. Whatever

■ IQ / OQ /PQ

■ Factory acceptance testing

■ Qualification of critical utilities

■ NIST traceable calibration

■ Customized validation protocols

■ Onsite protocol execution

■ Commissioning of equipment

■ Sanyo warranty service coverage

your validation needs are, SANYO provides
comprehensive expertise in laboratory
equipment to meet your exact compliance
needs. SANYO validation systems employ
advanced technology coupled with the latest
trends to insure compliance with accurate and
time efficient completion.

innovation
performance
reliability
support

v a l i d a t i o n

User Requirement

Manufacturer specs

DQ(choose equipment)

Commissioning

OQ Verifies Manufacturer

specs

PQ Ensures User

requirements are met

IQ Verifies Proper Setup

VALIDATION

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 devel­opment 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 in­cluding all required specifications manu­als 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.

VALIDATION SOLUTIONS

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 war­ranty 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.

IQ / OQ / PQ

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.

THERMAL 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, biotechnol­ogy and medical device (EN285, EN554)
manufacturing. Sanyo simplifies the entire
validation process by reducing setup time
and minimizing sensor handling, automat­ing 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

As the manufacturer we are the most
knowledgeable on our equipment. We
offer validation services for Sanyo equip­ment and a total solution in fulfilling
other regulatory requirement.

FACTORY ACCEPTANCE

We offer in depth factory acceptance
testing covering alarms as well as tem­perature/CO2 stability and recovery. This
service can also be customized to your
SOPs.