Software Solutions 

Approved to Provide Validatable Software Solutions to the Pharmaceutical Industry

Our systems deliver the necessary documentation required to support validation of automated systems.

The quality system is modeled after the internationally recognized GAMP Guide for Validation of Automated Systems. 

POA has been audited by several outside sources including Pfizer, Bend Research, Certified Facilities, and Validation Resources. 

Quote from software auditor, "You have succeeded in transforming the software capability maturity level of your company....the scope and depth of your quality system, coupled with the wise use of tools and the skill, professionalism and innovative flair of you all was most impressive." Howard G. Smith Software Quality Auditor    (GSAL Limited), England.
 

Deliverable documents

  • Project Plan
    Outlines the project scope, responsibilities, schedule, costs, and deliverables.
  • Functional Specification
    Describes each control functions operation, alarms, interlocks, user interface, data entry limits, etc.
  • Software Design Description
    Outlines the construction of the software by defining data tables, sub routines, communications configurations.
  • Factory Acceptance Tests 
    Used to bench test PLC to HMI data transfer, data entry limits, status indications, and numeric displays. This reduces startup time lines.
  • Site Acceptance Tests
    Used to verify the systems operation as installed at the customers facility. This document is often used as part of the OQ.
  • Program Backups
  • Disaster Recovery Plans
    Step by step instructions on reloading the programs after hardware failure or memory corruption.
  • Electrical Diagrams
    P+IDs, and component literature.


Projects:
    
McKesson RX Pak, Memphis TN
Validation of packaging line room environmental controls. POA has povided the Project tand Quality Plan, URS, Risk Assessment, Site Acceptance Test, and Validation Protocols (IQ, OQ, PQ) documents. POA is also involved in the execution of the test documents.

Validation Resources, Bend Oregon
POA designed, installed, and validated a temperature monitoring system for Validation Resources test stations and laboratory environments. The system provides a hard copy report of test temperatures and alarm messages for inclusion in the customers test protocols.

McKesson Specialty Logistics, Memphis TN
POA designed, installed, and validated a temperature control system for a drive in refrigerator used to store specialty theraputics for their customers distribution needs. POA provided a PLC based, UL Listed control panel to monitor and control the temperature and refrigeration equipment. 

Bend Research Pharmaceutical Process Development, Bend Oregon
Provided a control system for powder drying process.  The system utilizes  a PLC and Touchscreen to implement the batch and control functions.  POA provided the UL Listed control panel, installation, PLC and HMI programming, calibrations, startup, testing, and training. The deliverable documentation included O+M, Functional Specification, Software Design Document, and Site Acceptanc Test.   

Bend Research Inc. Bend Oregon
Retrofit to newly acquired used equipment from Glatt. POA provided installation, calibration, and a Wonderware user interface for the equipment.  

Bend Research Inc. Bend Oregon
Tablet Drilling System including positioning system, digital inspection cameras, and production. Develop portable skid for processing pharmaceutical tablets. Integrated user interface, motion control, digital camera quality control system, packaged laser, and data acquisition with Allen Bradley SLC500 control system.  The system determines which side of the tablet to process based on color detection sensors, presents tablet to the laser, proves presence of tablet, controls number of shots and power level.


61533 AMERICAN LOOP #1 - BEND, OR 97702 - PHONE: (541)330-1687 FAX: (541)388-8273 CCB#132555
Web System Provided by Smart Solutions. Visit us on the web at www.smartz.com.