May 3, 2016

Engineering and Validation

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Managing projects, Engineering Systems, and Testing (Commissioning, Qualification, and Validation) Services are core Innovative Process Solutions’ offerings.

Project Management & Engineering:  Since 1997, Innovative has managed, engineered, commissioned, and validated process and building systems, primarily for FDA-regulated life sciences companies.  And since 1999, Innovative has also managed skid-based and stick-built projects, and provided engineering and commissioning/qualification services for those projects.

Systems we have engineering and delivered include: bioreactors, CIP systems, large scale fermentation facilities, solid dosage systems, presses, powder handling systems, HVAC systems, and many others.

Validation: When permitted by clients, Innovative will take an ASTM E2500-07 approach to engineering and testing.  Our goal is to engineer quality into systems from the start, reduce the cost of testing, and reduce the long term cost of ownership.   We offer Risk Assessment standards and the deployment of Continuous and Periodic Review systems that make customers successful and efficient in meeting the FDA’s new Risk-Based standards.

Here are some examples of some computerized systems that we have commissioned and validated:

SystemDescription
Oracle E-Business SuiteIQ, OQ for several life sciences clients
DeltaVCommissioning, IQ, OQ for several life science clients
Change Notice SystemUAT, IQ, OQ: medical device manufacturer
Werum MESUAT, IQ, OQ: large pharmaceutical company
Honeywell ExperionCommissioning, IQ, OQ: large biotech company
Siemens Apogee BMSCommissioning IQ, OQ: many pharmaceutical companies
Rockwell / Allen-BradleyCommissioning, IQ, OQ: many clients
EurothermCommissioning, IQ, OQ: large biotech company
Modicon, GECommissioning, IQ, OQ: large pharmaceutical
Invensys I/ACommissioning, IQ, OQ: large biotech company
Weigh/DispenseIQ, OQ: large pharmaceutical company
Training/SOP MgtIQ, OQ: mid-sized biotech company

Quality & Validation Standards

TOOLS: Improve efficiency and quality with these tools

Ask us about the tools we use to lower validation and change control costs for computerized systems.

Emerson DeltaV – Control Studio specification, test document generation and change control tools

Honeywell Experion – Control Builder specification, test document generation and change control tools

Life cycle management tools for managing specifications, tests, risk assessment and change control for computerized systems

These quality assurance tools deliver tremendous efficiencies and ensure repeatable quality for client systems – as well as delivering standard reports and compliance visibility.