Vendor Suitability Analysis
What suitability criteria should be considered during selection of the vendor?
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Q(1): Is the Vendor experienced in the understanding and interpretation of the applicable
regulations in Design Qualification, Installation Qualification, Operational Qualification,
Performance Qualification, 21 CFR Part 11, Process Validation, and Method Validation?
A(1): Opulus employees have over 30 years of background and actual experience in the
development and design of products & services for the FDA & EU regulated industries, including
pharmaceutical, biotech & medical device companies, and research institutes.
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Q(2): Is the development of products follow life cycle process and based on meaningful SOP(s)?
A(2): Opulus development is based on life cycle process & relevant SOPs, that include
Product Concept, Requirements Analysis, Requirements Specification, Preliminary Design, Detailed
Design, Implementation, Integration, Verification & Validation.
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Q(3): Is the Vendor experienced in the creation & development of competency training &
SOP(s) for the products & services?
A(3): Opulus has developed competency training & SOP(s) for all of their products and
services. In addition, Opulus offers on-line Web-training and complete solutions for competency
training management, administration, scheduling, competency metrics, and competency evaluation
(see, http://cactus.opulus.com plus
Training Warehouse &
SOP Warehouse).
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Q(4): Is the Vendor competent & experienced in the support of system set up and completion
of DQ-IQ-OQ-PQ?
A(4): Opulus provides competent support for the set up and completion of DQ-IQ-OQ-PQ.
In fact Opulus provides expertise & competency training for other Vendors for DQ-IQ-OQ-PQ.
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Q(5): Is the Vendor competent & experienced for the compliance verification of 21 CFR Part 11?
A(5): Opulus provides competent support for the compliance verification of
21 CFR Part 11 requirements. Opulus has consulted others in the assessment, gap analysis, and
resolution relative to 21 CFR Part 11 compliance. In addition to on-site support, Opulus offers
on-line Web verification system called CIPER (Computer Integrated Part Eleven Resolution) at
significant cost savings.
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Q(6): Is the Vendor competent & experienced in the calibration, maintenance and full
system validation processes?
A(6): Opulus provides competent support for the calibration, maintenance, and
validation of the system. Opulus can integrate these requirements with SOP(s) and competency
training.
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