The Challenge
A leading international pharmaceutical company chose Avid Solutions for an
upgrade project in one of its manufacturing facilities in the U.S. In
line with an overall corporate initiative to come into compliance with 21 CFR
part 11 FDA regulations, the plant required a significant update to its
Intellution system. The company engaged Avid Solutions to take on the
project from design through implementation including validation documentation
and execution.
The Approach
The plant’s Fix 32 version of Intellution did not include the tools needed for
Part 11 compliance. In upgrading the system to version iFix3.5, Avid Solutions
configured Part 11 electronic signature requirements into the system.
The project involved 8 SCADA server configurations, of which 3 are redundant
pairs; 5 iFix clients; 2 redundant terminal servers with 14 iFix thin clients,
and 1 iHistorian server with InfoAgent with multiple web pages for viewing
historical data. Alarm/event records are stored in an Oracle database for Part
11 compliance. Avid Solutions developed the complete lifecycle documentation
package including multiple FS and DS documents used to design the upgraded
system and the IQ and OQ documents to test the system. Avid also developed the
trace matrix and executed the IQ and OQ protocols.
Prior to the Intellution upgrade, Avid designed, configured, tested and installed the iHistorian system, a key quality control tool for the company. The iHistorian establishes a detailed audit trail, and permits sophisticated trending and analysis of multiple process variables. Additionally, Avid completed a Work-in-Process (WIP) inventory tracking system using multiple barcode scanners to track all parts and pieces of the filling line process. The WIP system employed web-based forms and reports and interfaced with an Oracle database for parts look-up and historical tracking.
The Results
The client company’s facility now meets the FDA’s requirements for electronic
signatures and electronic records. Additionally, the system reliability was
increased because of the redundant SCADA servers and redundant iFix Terminal
Servers.
Actavis
APP Pharmaceuticals
Biogen Idec
Eisai
GlaxoSmithKline
Hospira
Medimmune
Novo Nordisk
Pfizer
Sandoz
Talecris
United Therapeutics
Fluid Bed Dryers
Solution Delivery
Electronic Batch Records
Film Coating
CIP / SIP
Blenders and Fitz Mills
Freeze Dryers
HVAC
Lyophilizers
Product Milling
Building Automation
Test Documents
Validation Execution
Packaging & Inspection
USP / WFI
