Commissioning and Qualification services where the cost to client companies is the lowest and the positive impact on project schedule is the highest.
Since 1997, commissioning and qualification services for biotech, pharmaceutical and medical device manufacturers has been a core offering to our clients. All of our engineers have extensive experience with commissioning and qualifying automation, batch automation, and enterprise software systems. When in accordance with client philosophy, we work to ensure that FAT, SAT, UAT and commissioning tests can be leveraged so that project risks are mitigated as early in the project life cycle as possible – when the cost to client companies is lowest and the positive impact on schedule is highest.
Moving the bolus of work to the earliest stages of projects, when costs are lowest, is what the risk-based validation approach, endorsed by the FDA, is all about. However, we follow our clients’ philosophies on each job and those philosophies vary widely.
Our team has spent extensive time thinking through risk assessment and change control processes and philosophies that make sense for clients. Let us help you with your next quality assurance project.
Systems that we have commissioned and qualified:
|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||Comissioning IQ, OQ: many pharmaceutical companies|
|Rockwell / Allen-Bradely||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
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 enterprise 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.