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:
|Oracle E-Business Suite||IQ, OQ for several life sciences clients|
|DeltaV||Commissioning, IQ, OQ for several life science clients|
|Change Notice System||UAT, IQ, OQ: medical device manufacturer|
|Werum MES||UAT, IQ, OQ: large pharmaceutical company|
|Honeywell Experion||Commissioning, IQ, OQ: large biotech company|
|Siemens Apogee BMS||Commissioning IQ, OQ: many pharmaceutical companies|
|Rockwell / Allen-Bradley||Commissioning, IQ, OQ: many clients|
|Eurotherm||Commissioning, IQ, OQ: large biotech company|
|Modicon, GE||Commissioning, IQ, OQ: large pharmaceutical|
|Invensys I/A||Commissioning, IQ, OQ: large biotech company|
|Weigh/Dispense||IQ, OQ: large pharmaceutical company|
|Training/SOP Mgt||IQ, OQ: mid-sized biotech company|
Quality & Validation Standards
- ASTM E2500 -07 Standard Guide for Specification, Design, and Verification of…
- GAMP5 – Risk-based Approach to Compliant GxP Computerized Systems
- 21 CFR 11 – Electronic Records; Electronic Signatures
- ICH Q9 – Quality Risk Managment
- ICH Q10 – Pharmaceutical Quality System
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.