We deliver CONFIDENCE every day

About Us

Gill’s has provided validation and documentation services for the Pharmaceutical Industry in Eastern North Carolina since 1995. We are proud to be part of a process that helps deliver a consistent, safe product to those supporting the health care needs of the U.S. and the world.

SERVICES

  • Engineering Turnover Packages (ETOP)

  • Commissioning

  • Factory Acceptance Test (FAT)

  • Site Acceptance Test (SAT)

  • Automated Process Control System Documentation

  • Equipment Validation Documentation

  • Validation Plans

  • Gap Analysis for Legacy Systems

  • Risk Assessments

  • Failure Modes Effects Analysis (FMEA) • Installation Qualifications (IQ)

  • Operational Qualifications (OQ)

  • Performance Qualifications (PQ)

  • User Requirements Specifications • Detailed Design Specifications

  • Trace Matrices

  • Summary Reports

  • Standard Operating Procedures

automation and control system validation

Gill’s started as a controls integration company. After a few years it became evident that the validation and compliance of automated systems was of great importance to the regulating agencies and to our clients. Our validation specialists understand control systems and the technology used to manufacture product. We are experienced in generating requirement and design specifications for all types of automated systems. 

We are able to review HMI applications and PLC programs to generate life cycle documents and to develop specific test scripts.  

  • Allen-Bradley PLCs and HMIs

  • Siemens PLCs and HMIs

  • Systech Vision Systems

  • Cognex Vision Systems

  • Wonderware HMI/SCADA and Data Historian

  • Intellution HMI/SCADA

EQUIPMENT VALIDATION

Gill’s has experience with many different types of equipment. Based on our experience we are able to assist with developing validation strategies for a variety of manufacturing equipment and systems. Gill’s can assist with factory acceptance and site acceptance testing.

We can also assist with developmental testing to establish equipment parameters and operating limits.
As part of the validation planning, methods can be determined for best case testing of established parameters and number of test cases needed to gain a high degree of confidence in the equipment performance. 

FILLING AND DOSING SYSTEMS

  • Liquid Filling (Aseptic, Terminally Sterilized and Isolator)

  • Solid or Powder Dose
    (Compression, Encapsulation and Banding)

  • Coating and Imprinting

  • Drying and Spraying (Dry Powder or Fluid Bed Granulation)

STERILIZATION

  • Product and Commodity Sterilization systems

  • Steam Sterilizer (Aseptic and Terminal)

  • Dry Heat Sterilizers

  • Hydrogen Peroxide

  • Isolator Sterilization

  • Gamma Irradiation C60

  • Clean in Place (CIP)

  • Steam or Sterilize in Place (SIP)

LABELING AND VISION SYSTEMS

  • Labelers (Pressure Sensitive and Thermal)

  • Vision Systems Using Recognition Technology

  • Primary Label Commodity Codes and L&E

  • Labeling and Inspection for HIBC and Barcodes

  • Laser Printing and Data Integrity

PACKAGING

  • Inventory Recognition Systems Including RFID

  • Heat Tunnels and Blister Pack Studies

  • Cartoners, Trayers, Checkweighers, Inkjets, Case Formers and Tapers