Deaton Engineering

Validation. Compliance. Confidence.

Why Validation Matters — and Why Deaton Engineering is Your Ideal Partner

Validation Services Brochure

A robust validation program not only ensures regulatory compliance—it sets your organization apart in a competitive market. Effective validation confirms that systems perform as intended, guarantees that products meet the highest standards of quality and safety, and significantly reduces the risk of FDA 483 observations.

At Deaton Engineering, we specialize in helping clients succeed across the full spectrum of validation challenges—whether you’re launching a new process, upgrading legacy equipment, or preparing for an audit. We leverage a risk-based, Total Quality Approach rooted in current Good Manufacturing Practices (cGMP), which allows us to deliver results even in the most complex environments.

Deaton is committed to engineering-driven solutions. Our validation projects are executed by experienced engineers—not technical writers—who deeply understand your systems and processes. We take the time to assess every interrelated system to develop documentation that stands up to regulatory scrutiny and supports long-term compliance.

Validation is not just a checkbox—it’s a continuous improvement tool. From process equipment and control systems to full facility validations, our team is equipped to prevent compliance issues or help remediate them when they occur. With Deaton, you gain a partner committed to quality, compliance, and operational excellence.

Validation engineering: validation master plan, GMP criticality review, requirements analysis, user requirements, risk assessment, functional specification, vendor qualification, design specification, SOP, IQ, OQ, and PQ.

A Risk-Based Approach to Validation Services

Regulatory Inspection & Audit Readiness

  • Inspection readiness assessments
  • Support for FDA/EMA audits
  • 483/CAPA response support and remediation execution

Validation Master Planning (VMP)

  • Development of compliant, risk-based Validation Master Plans
  • Defines scope, systems impact, scheduling, roles, and responsibilities
  • Regulatory strategy built for successful inspections

Commissioning & Qualification (FUSE CQV)

  • Full lifecycle qualification: DQ, IQ, OQ, PQ
  • Utility qualification: Clean Steam, WFI, HVAC, Compressed Air, etc.
  • Equipment qualification: Autoclaves, Bioreactors, Cleanrooms, etc.
  • Installation and start-up support

Automated Process Control Systems (APCS)

  • Control systems and Building Management Systems (BMS)
  • SCADA, PLCs, and DCS qualification
  • Verification of alarm management, audit trail, user access, and data integrity

Protocol Development & Execution

  • Development of IQ, OQ, PQ, FAT, SAT, and custom protocols
  • Execution of validation activities with clear, audit-ready documentation
  • Deviation management and change control coordination

SOPs & Quality Document Support

  • Creation, revision, and harmonization of SOPs
  • Development of validation templates and standardized documentation
  • Onboarding and training of QA/QC and operational personnel

Risk-Based Assessments & Gap Analysis

  • System impact assessments
  • GMP criticality ranking
  • Remediation strategies for legacy or undocumented systems
  • Data integrity assessments

Computer System Validation (CSV)

  • Validation of GxP-relevant software applications
  • Aligns with GAMP 5 guidelines and 21 CFR Part 11
  • Services Include:
    • User Requirements Specification (URS)
    • Risk assessments and traceability matrices
    • Test planning and execution (IQ/OQ)
    • Audit trail and electronic signature verification
    • Validation reporting and change control support
  • Systems: LIMS, QMS, ERP, MES, Document Management Systems, e-Logbooks, and cloud/SaaS platforms

Working With Deaton Engineering

At Deaton Engineering, we are committed to helping you leverage modern technologies to bring innovative products to market faster, with greater efficiency and a stronger return on investment. Our custom-engineered solutions are designed for seamless installation, intuitive operation, and low-maintenance performance—all with minimal engineering support required. By reducing training needs, operator intervention, downtime, and revalidation efforts, we help lower your total cost of ownership while maximizing system uptime and reliability.

FAQs:

What does CQV stand for, and why is it important?

CQV stands for Commissioning, Qualification, and Validation. It’s a structured, regulatory-driven process that ensures facilities, utilities, systems, and equipment are properly designed, installed, and operating according to their intended use. It’s a critical step for ensuring compliance with FDA, EMA, and global GxP regulations.

What industries does Deaton Engineering support?

We support FDA-regulated industries, including:

  • Pharmaceuticals
  • Biopharmaceuticals
  • Medical Devices
  • Contract Development and Manufacturing Organizations (CDMOs/CMOs)
  • Research laboratories and startups working with regulated products
How is Deaton Engineering different from other validation providers?

We bring a hands-on, engineer-led approach to every CQV and CSV project. Our team delivers:

  • Audit-ready documentation
  • Risk-based strategies aligned with GAMP 5 and ICH Q9
  • Practical field experience and regulatory insight
  • Custom validation plans tailored to your systems—not a one-size-fits-all template
Do you offer Computer System Validation (CSV) services?

Yes. We specialize in CSV for:

  • SaaS/cloud-based platforms
  • Quality Management Systems (QMS)
  • Laboratory Information Management Systems (LIMS)
  • MES, ERP, Document Control, and more

Our CSV services align with 21 CFR Part 11, Annex 11, and GAMP 5 standards.

Can Deaton Engineering help us prepare for an FDA or EMA inspection?

Absolutely. We offer:

  • Gap assessments
  • Data integrity audits
  • SOP and documentation reviews
  • Remediation of 483 or audit findings
  • Staff training to ensure inspection readiness
What types of validation protocols do you develop and execute?

We provide complete lifecycle validation protocols, including:

  • Design Qualification (DQ)
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Factory & Site Acceptance Testing (FAT/SAT)

All protocols are fully traceable and compliant with regulatory expectations.

Do you support both greenfield projects and legacy system validations?

Yes. Whether you’re starting a new facility or upgrading legacy systems, we tailor our CQV approach to your needs—minimizing downtime and maximizing compliance.

Can Deaton Engineering provide onsite and remote validation services?

Yes. We offer hybrid service models that combine onsite execution with remote documentation development, reviews, and digital collaboration, ensuring flexibility and efficiency.

What’s included in your Validation Master Plan (VMP)?

Our VMPs include:

  • Scope and system inventory
  • Validation strategy and risk rationale
  • Roles and responsibilities
  • Project schedule and milestone planning
  • Acceptance criteria and change control mechanisms
How do I get started with Deaton Engineering?

Start by contacting us for a consultation. We’ll evaluate your needs and propose a tailored validation plan.

Why is validation engineering crucial for Texas industries?

Start by contacting us for a consultation. We’ll evaluate your needs and propose a tailored validation plan.

  • Regulatory Compliance: Meeting federal and Texas state regulations, especially in industries like pharmaceuticals and medical devices.
  • Product Quality: Ensuring products are safe, effective, and meet quality standards.
  • Risk Mitigation: Identifying and addressing potential issues before they impact production.
What areas can Deaton’s validation team help my company with?

  • GMP, cGMP, GLP, GAMP
  • System validation
  • Equipment validation
  • Process validation
  • 483 warning letters
  • Good manufacturing practices
  • Good laboratory practices
  • FDA compliance
  • Standard operating procedures (SOP)
  • User requirements specifications (URS)
  • Functional requirements specifications (FRS)
  • Software requirements specifications (SRS)
  • Validation gap analysis
  • Validation master plan
  • Installation qualifications (IQ)
  • Operational qualifications (OQ)
  • Performance qualifications (PQ)
  • Risk assessments
  • Hazard analysis
  • Deviation resolutions
  • Traceability matrices
  • Calibration management
  • Factory acceptance tests (FAT)
  • Site acceptance tests (SAT)
  • Network qualification
  • 21 CFR Part 11
  • Process control system gap analysis & validation
What systems and equipment can Deaton help my company validate/qualify?

  • Automated process control systems
  • Batch autoclaves
  • Boilers
  • Bulk material storage and silos
  • Cap assembly machines
  • Chillers and cooling towers
  • Clean in place (CIP) systems
  • Compressed air systems
  • Clean rooms
  • Clean steam generators
  • Coating systems
  • Continuous and batch sterilizers
  • Conveyor systems
  • Cryogenic equipment
  • Cutting systems
  • Dual chamber IV bag fabricators
  • Environmental enclosures
  • Extruders
  • Food grade printing systems
  • Form, fill, seal systems
  • HEPA filtration systems
  • HVAC control systems
  • Industrial inspection systems
  • Industrial robots
  • Measurement systems
  • Metal detection systems
  • Microwave pasteurizers
  • Miniature parts and mechanisms
  • Motor generator sets
  • Packaging & labeling equipment
  • Pick and Place machines
  • PLC and DCS control systems
  • PLCs, HMIs and computer controls
  • Pressure/vacuum vessels
  • Process hot water systems
  • Process piping systems
  • Process reactors
  • Process skids
  • Product handling equipment
  • Purified water and WFI systems
  • Rack mount equipment
  • Refrigerated storage
  • Robotic handling machines
  • Rotating equipment
  • Sanitary equipment
  • Scales and check-weighers
  • Shrink wrappers
  • Solution preparation systems
  • Stability incubators
  • Steam systems
  • Sterilize in place (SIP) systems
  • Thermal oxidizers
  • Total organic carbon (TOC) analyzers
  • Tote bin blenders
  • Vacuum chamber design and analysis
  • Vacuum conveyors
  • Vacuum environments
  • Vessels and tanks
  • Vision systems
  • Wave solder fixtures
  • Weldments and enclosures
How can Texas companies collaborate with Deaton Engineering for validation services?

Companies can contact Deaton Engineering here or visit their Georgetown, Texas headquarters, a suburb of Austin, for consultations. Deaton provides engineering, design, automation, and validation services across Texas, including in Austin, Dallas, Fort Worth, Waco, Houston, and San Antonio.