Industries Served Centers of Excellence Case Studies

Industries Served

Coda Corp USA supports pharmaceutical, biotech, and medical device industries.

Coda Corp USA primarily services Quality and Operations Business Units, developing, implementing, and validating quality systems and processes, provides general compliance services, and offers sustainable solutions to modern manufacturing challenges.

Centers Of Excellence

Coda Corp USA provides its services to some of the largest and fastest growing industry leaders including multi-national, national, and start-up firms, and contract service providers (manufacturers, packagers, and research/clinical).
Coda Corp USA’s Centers of Excellence include the following:

Six Sigma and Lean Project Management*:

Project Management is an integral part of every Coda Corp USA project. Coda Project Managers are trained in Six Sigma and Lean techniques, and are widely utilized throughout the industry to optimize innovation and deliver consumer centric quality and sustainable results.

Project Management services include:

  • Strategic planning
  • Process evaluation and assessment and variation identification
  • Identification of opportunities for continual improvement
  • Metric identification and tracking, progress reporting
  • Program tool design and development
  • Issue and conflict resolution and team building
  • Leadership communication and mentoring
  • Jr. staff professional and technical development

Coda’s experience managing projects is as diverse as our project history including, but not limited to:

  • Capital Improvement/Expansion Projects – construction and qualification of new facilities, process scale up/technology transfer, validation of product processing lines, configuration, validation and implementation of global automation, PAI readiness management and preparation
  • Quality System Development and Implementation – Corporate Change Management, Problem Investigation, CAPA Management, Material Control and Lot Release, Document Control, Storage and Retention, and Training
  • Documentation Design and Generation – Operating procedures, protocols, Master Batch Records, Master Equipment Files, Label Control and Reconciliation forms, Material and Batch Reconciliation forms, Controlled Substance usage forms, requirement and specification tracking and management tools
  • Regulatory Compliance – Definition of responses to findings, Management of Implementation of Commitments, Implementation of Process Modifications

Quality Systems*

The development and implementation of comprehensive Quality Systems is a core service provided by Coda Corp USA. Clients have initially contracted Coda to provide these services, and have then expanded Coda’s scope of work to include redesign of existing systems.

Many of Coda contracts included the development or redesign of at least one Quality System prior to project completion.

Quality System development and implementation requires:

  • Championing change in order to reach alignment of expectations of partner business units
  • Process mapping
  • Deliverable identification
  • Timeline definition and management
  • Generation of deliverables
  • Implementation of system attributes and training

Coda’s experience developing and implementing Quality Systems and associated training programs has included:

  • Change Management
  • Training
  • Deviation, NCM, OOS Investigation and Resolution
  • Corrective and Preventative Action Definition and Management
  • Validation Planning and Management
  • Design and Process Control Development and Measurement
  • Controlled Documentation Generation, Distribution, Maintenance, and Retention
  • Raw Data Generation, Collection, and Handling
  • Audits – Internal and Supplier
  • Product Release, Product Recall, Product Rework
  • Customer Complaints, Adverse Events, Field Reporting
  • Component and Material Control

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 fundamental 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
  • MES/MRP
  • EDC
  • EDMS
  • PLC, SCADA
  • Clinical
  • e-submission
  • Automated Inspection
  • Label Control Systems
  • E-batch records
  • BAS systems

Professional Development*

Coda is committed to the value of ongoing education and development. Therefore, Coda endeavors to keep current the knowledge base of its own staff, and offers many services that will enable clients to do the same for their staff. Coda also conducts regular, public training seminars on behalf of many industry groups and associations.

Coda provides full service programs in the following areas:

  • Traditional Training Classes
  • Mentoring for senior resources
  • Professional Development for junior resources

At the request of any client, Coda will prepare and deliver custom training classes, delivered by professionally trained trainers. Coda will adapt format and approach, as well as style to the needs of the particular request.

Coda also offers a full complement of standard training materials for those clients that are seeking to develop training libraries of their own, for regular/routine usage.