Automation and Contol Panel Design in Michigan
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Equipment Validation with FDA Regulated Environments Equipment Validation with FDA Regulated Environments

 

Equipment Validation
We have pharmaceutical validation experience with the following type of manufacturing lines and associated equipment:

Filling Lines:
Unscramblers, Sterile/Non-Sterile Fillers, Vial/Bottle Washers, LATs (Loading Accumulation Tables), UATs (Unloading Accumulation Tables), Freeze Dryers, Cappers and Neckbanders.

Packaging Lines:
Labelers, Cartoners, Casepackers, Palletizers, Conveyors and Product Transport Equipment.

Documentation
We have experience within FDA regulated environments and act in accordance with cGMPs (Current Good Manufacturing Practices).

We remain current and in compliance with the following federal regulations:
• cGMPs (21CFR Part 210 and 211)
• Electronic Records and Signatures (21 CFR Part 11)
• Quality System Regulations (21 CFR Part 820)

We can create documentation with ensuing protocol execution.
• User Requirements
• Functional Specifications
• Design Documents
• Flow Charts
• Sequencing Spreadsheets
• FATs (Factory Acceptance Tests)
• IQ (Installation Qualification)
• OQ (Operational Qualification)
• PQ (Performance Qualification)
• Disaster Recovery Procedures
• Operating Procedures (SOPs, PMs)

 
 

Precision Control
Integrators, Inc.

10440 S Ave E • Scotts, MI 49088
Office: (269) 626-0306
Fax: (269) 626-0288
Click Here to Email Us
PCI COMPANY PROFILE
“Precision Control Integrators Inc. can provide the productivity control solutions to meet your automation needs.  We have the expertise to successfully integrate your electrical and mechanical processes into a highly efficient system.”

Precision Control Integrators provides full installation, training and support to help you with all aspects of your automation needs. Contact us today for PCI Solutions. more


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