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Qualification and Validation Services

  • New Facilities and Products (Pharmaceutical, Biopharmaceutical, Medical Device)
  • Experimental Design and Process Development
  • Strategy and Approach Planning
  • Validation Project Management
  • Equipment Qualification
  • Facility and Utility
  • Facility and Utility for Biologic Facilities
  • Process Validation (Manufacturing and Packaging)
  • Sterile Processing
  • Sanitation Validation
  • Sterilization Validation
  • Enterprise and Local Automation


Quality Engineering

  • Design Control and Planning
  • Technology Transfer
  • Facilities and Utilities Planning
  • Vendor Evaluation
  • Equipment and Automation Selection and Factory Acceptance Testing
  • Process Development and Optimization
  • Risk Management and FMEA



Coda Corp USA excels in Validation services.

The following Examples of Excellence highlight Coda’s experience:


Process Validation

The design and execution of Process Validation studies is one of the fundamental core strengths of Coda Corp USA.  Coda’s core staff began primarily focused in the Process Validation arena.

Coda has led, contributed to, or participated in the following types of projects for Pharma, Bio, and Medical Device clients:

  • Product Manufacturing – bulk, intermediate, finished dose (liquid and solid)
  • API Blending/Drying
  • Liquid/Solution Mixing
  • Product Packaging (primary and secondary) – insert/outsert placement, bottles (cleaning, filling, and capping), boxes, blister packs, vials, hypodermics, label placement
  • Component Preparation – component cleaning, sealing
  • Manufacturing Automation
  • Automated Inspection – Vision, laser, digital imaging, height and weight, hardness and thickness, torque
  • Cleaning – in and out of place
  • Sterilization – in and out of place
  • Depyrogenation
  • Fermentation
  • Sterile Filtration
  • Water Purification
  • Waste Inactivation

The services provided to projects of this nature have included, but are not limited to:

  • Approach and program definition
  • CPP and CQA determination
  • Load Configuration development and optimization
  • Strategy and planning
  • Protocol design, preparation, execution, and reporting
  • Statistical Analysis
  • Process improvement


Equipment, Facility, and Utility Qualification

The design and execution of Equipment, Facility, and Utility Qualification studies is a core strength of Coda Corp USA.  Many of Coda’s projects delivered have begun with the evaluation of the facilities, utilities, and equipment associated to those processes.

The types of facility, utility, and equipment Coda has experience qualifying in include, but are not limited to:

  • High speed liquid and solid manufacturing equipment
  • High speed liquid and solid packaging equipment
  • Labelers
  • In Process and In Line Measuring/Monitoring equipment
  • Sterile Supply equipment   – autoclaves, dry heat ovens, heat sealers, washers, sonicators
  • Controlled Thermal Units – walk in coolers, freezers, stability chambers, incubators, thaw baths
  • Laboratory Instrumentation
  • Utility Generation and Distribution
  • HVAC
  • Automated Building Climate Control Systems
  • WFI, PW
  • Process Air and Steam
  • Process Nitrogen, Glycol
  • Clean Steam


Software Validation and Part 11

Coda Corp USA is an industry acknowledged leader in the automation validation arena.   Coda’s COO, who was a founding member of the GAMP Part 11 Special Interest Group (SIG), conducts industry-wide training seminars on the topic, as well as regularly publishing articles in widely circulated industry journals and associations.

Coda also has developed and copyrighted many Part 11 implementation tools currently utilized by industry leading software vendors and their clients (e.g., Pharmaceutical, Biological, Medical Device, and Clinical Research Organizations).

Coda’s experience in managing the following aspects of this type of projects is considerable:

  • Configuration and validation of the technological and procedural controls required in order to comply with Part 11
  • Development and implementation of automation change management systems
  • Automation Compliance training

The applications at the center of Coda’s projects include, but are not limited to:

  • LIMS
  • EDC
  • EDMS
  • Clinical
  • e-submission
  • Automated Inspection
  • Label Control Systems
  • E-batch records
  • BAS systems