Automated Systems Inc. has been providing the life sciences industry with controls and validation support for over 25 years. From this long history of service to the industry, ASI has selected the following projects to demonstrate our proven track record of success with process / equipment validation.  

Qualification of a Grass Roots OTC Manufacturing Facility

ASI began this project by working with our client to author the project validation master plan for a 500,000 sqft grass roots facility in Jonesboro, Arkansas.  The validation master plan and subsequent activities included validation of the following systems within the plant:

  • Process Equipment
  • Critical Utilities
  • Environmental Control Systems
  • Automated Systems
  • Manufacturing and Cleaning Processes
  • Software Systems
  • Laboratory Test Methods and Instrumentation

 The equipment and systems validated were for use in dispensing, weighing, compounding, filling, and packaging of OTC products which consisted of emulsions, creams, and liquids.

Commissioning and Qualification of a New Bulk Blood Fractionation Facility

ASI was contracted to commission and qualify production and support equipment used in the manufacture of bulk products. The facility included cGMP compliant manufacturing areas, personnel gowning rooms, mechanical spaces, and staging areas required to support the manufacturing processes. Equipment included:

  • Slurry Tanks
  • Filter Presses
  • Ultrafiltration/Diafiltration Tanks and Skids
  • CIP Skids
  • Buffer, Prep and Final Formulation Tanks
  • An Equipment Washer

 ASI was responsible for delivery of commissioning, IQ, and OQ protocols.

Analytical Instrument Data Integrity Remediation

ASI won a bid to provide project management and validation services as part of an on-going effort to perform Part 11 remediation for selected stand-alone analytical laboratory equipment. ASI’s role was to ensure data integrity through the configuration and validation of pre-defined interim controls to Operating Systems, application software and system SOPs to prevent deletion of data. In addition, ASI identified, investigated, resolved and closed all applicable incidents encountered during the course of the validation.

 Specific deliverables included:

  •  Validation project plan including project timeline, tasks, resources, deliverables and budget
  • Change Request for each system
  • Interim controls for each instrument, specific to the client’s requirements
  • A trace matrix for each system
  • Instrument user, administration and change control SOPs
  • Protocols (IQ/OQ/PQ) with test scripts designed to test each system against all requirements
  • Validation summary report for each instrument to summarize all validation activities and the overall results of the validation effort