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Service Areas

At C&A, our main goal is to provide you with highly professional quality services. Our mission is to assist your team in any area throughout the entire life-cycle of your Facility, Equipment and/or Utility (FEU), whether you are anywhere in the planning, design, build, qualify, operate, maintain or decommission stage of your system. We are well aware that providing robust, quality assistance will result in safe efficacious product. Our approaches are grounded in scientifically sound, quality based strategies that are delivered in a timely and cost-efficient manner.

Quality
Quality Systems Support and Compliance

 

C&A will provide robust Quality System support in all areas of your compliance needs ensuring governmental regulation requirements are effectively met. Our engrained knowledge in quality systems comes from our specific involvement with company’s internal audits, government regulated inspections, a combined consortium of previous work experiences and implementation and roll-out of quality systems for new start-ups.  We can serve as consultants for the spokesperson for your organization to defend your site and company practices during internal audits and regulatory inspections.  Our subject matter experts within our Quality System team have an established network for quality and compliance issues within the industry. 

 

 

 

 

 

 

 

Areas of Focus:

 

  • CAPA Management and Implementation

  • Change Control Ownership and Management

  • Discrepancy Investigation and Root Cause Analysis

  • Gap Analysis and Remediation

 

  • Internal Auditing and Inspection Readiness

  • Reliability Engineering

  • Revalidation and Periodic Review

  • Supplier/Vendor Audits

  • Training Assistance

  • Good Documentation Practices (GDP)

Project Management
Project Management and Delivery

 

When your Project Managers (PM) work in progress (WIP) approaches full capacity, we can provide relief to your internal staff with our team of experienced consultants.  We’ve managed teams working on a diverse scope of complex problems and initiatives.  Our PMs will author GMP Project Plans, generate detailed project schedules and track milestones, manage and report on project budgets, evaluate bids and facilitate meetings.  Each C&A individual possesses effective leadership, communication and organizational skills, and with our specific experience in the BioPharma sector, our PMs possess a strong background of technical knowledge to ensure your project runs smoothly and efficiently.

 

    

 

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Areas of Focus:

 

  • Construction Management for GMP

  • Contract Management

  • Project Management (Traditional or Alternative)

  • Small or Large FEU Modifications

  • Startup and Commissioning Coordination

  • Risk Management 

  • Vendor Procurement and Management

Design and Planning
Design and Planning

 

Our process engineers bring to the table years of practical experience providing design solutions that comply with your site’s Good Engineering Practices (GEP) program. We can provide design and planning assistance for your production groups such as Process Engineering, Manufacturing Operations, Manufacturing Science and Technology (MSAT), Facilities Management and Environmental Health and Safety (EHS).

 

Areas of Focus:

 

  • Design Specification Generation

  • Design Qualification Execution

  • Engineering Design Review

  • Functional Specification Generation

  • Hazard Review

  • Process and Equipment Development

      Testing

 

  • Qualification Project Plans

  • Requirements Traceability

  • Risk Assessments

  • SOP Generation and Revision

  • User Requirement Specification

       Generation

Commission and Planning
Commissioning and Validation Qualification
 

C&A will address all of your validation needs.  Our support runs the gamut of all validation approaches (prospective, retrospective, family/grouping, worst-case, overkill, etc.) and we specialize in a risk-based approach, using risk assessments to provide rationale for the level of documentation and rigor of testing to ensure compliance.  From the design and planning, to build and test, to operate and maintain and ultimately decommissioning, we support the comprehensive qualification lifecycle of your GMP impact facility, equipment, utility (FEU) and GMP process. 

 

Unlike other firms, we don’t use boiler plate templates because we know there is not a turnkey solution for your needs.  Our validation engineers and consultants utilize a “life-cycle scalability” model since qualification activities are dependent on the scale, complexity and intended use of the FEU or GMP process.  While our qualification deliverables may be project specific, each document published and executed by C&A will comply with your validation program’s requirements.

 

Areas of Focus:

 

 

 

  • Q/OQ/PQ

  • Packaging and Shipping Validation

  • Process Characterization

  • Process Validation

  • Risk Assessment and Risk Management

  • Small and Large Modifications to Existing Validated FEUs

  • Acceptance Criteria Development and Justification

  • Automation Validation

  • Cleaning Validation

  • Cold Chain Qualification

  • Decommissioning

  • Facilities/Equipment/Utilities Validation

  • Information Systems Validation

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