CQV & Validation Services
Ensuring systems consistently operate within defined parameters. Our validation services ensure all systems, equipment, and processes consistently operate within defined parameters to produce reliable and compliant results.
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Led byDon Carter, Principal, Validation
The first call is discovery, no confidential details needed. We sign a CDA before any detailed review.
Ensuring Systems Consistently Operate Within Defined Parameters
Whether you’re launching a new facility, expanding operations, or remediating existing systems, we meet you where you are. Our team works alongside yours to design practical, resource-conscious validation strategies that support inspection readiness and drive lasting operational results.
Don CarterPrincipal, ValidationDon leads facility commissioning, equipment qualification and process validation for FDA-regulated manufacturers and 503B outsourcing facilities. He brings over 15 years spanning formulation, validation engineering and quality operations, including leadership roles in sterile manufacturing.
- Equipment commissioning and qualification
- Sterilization and thermal validation
- 503B process and facility validation
Kristopher Le, PharmDCEO & FounderComprehensive CQV Service Offerings
Facility & Equipment CQV, IQ/OQ/PQ Execution
End-to-end commissioning, qualification, and validation services for facilities, utilities, equipment, and support systems, including IQ/OQ/PQ protocol development and execution. We use a systematic, risk-based approach to confirm systems meet specifications, function properly, and are ready for GMP use.
Computer System & Software Validation (CSV)
Comprehensive validation of computerized systems and software applications used in GMP operations, ensuring data integrity, system reliability, and compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. We validate systems across their entire lifecycle from specification through retirement.
Validation Master Planning & Lifecycle Management
Strategic planning and ongoing management of validation activities across your entire operation. We develop comprehensive Validation Master Plans (VMPs) that define validation strategies, prioritize activities, allocate resources, and establish ongoing lifecycle management programs to maintain validated status.
Thermal Mapping & Specialized Validation
Temperature mapping and qualification of controlled storage areas, CTUs, and critical environments, along with steam cycle qualification and sterilization validation. We ensure thermal consistency, equipment performance, and compliance with GMP and regulatory expectations.
Cleaning Validation
Establish documented evidence that cleaning procedures effectively remove product residues, cleaning agents, and contaminants to acceptable levels, preventing cross-contamination between batches and products. Our cleaning validation programs ensure patient safety and regulatory compliance.
Our Validation Process
Assessment & Planning
Evaluate system requirements, define validation scope, perform risk assessment, and develop comprehensive validation strategies.
Protocol Development
Create detailed validation protocols with clear objectives, acceptance criteria, test procedures, and documentation requirements.
Execution & Testing
Execute validation protocols systematically, perform all testing activities, document results, and investigate any deviations.
Review & Approval
Prepare summary reports, conduct quality review of all documentation, and obtain final approvals from stakeholders.
Lifecycle Maintenance
Establish ongoing monitoring, implement change control, schedule periodic reviews, and maintain validated status over time.
Continuous Improvement
Analyze validation data, identify optimization opportunities, update procedures, and refine validation strategies based on experience.
Why Work with Amicus?
Experienced team with proven expertise across facility, equipment, and process validation programs
Efficient outcomes helping you launch, qualify, and operate with confidence and compliance
Adaptive support tailored to your stage, scale, and operational maturity
Hands-on execution going beyond protocols to implement sustainable solutions
Amicus in the Field
Trusted Partners in CQV
Real partnerships delivering sustainable solutions across pharmaceutical and biotech development.
The validation support from Amicus was excellent. Their team brought real-world CQV experience that helped us commission our new facility on schedule while staying aligned with our validation master plan and regulatory expectations.
VP Technical OperationsCDMO
Amicus provided hands-on support as we scaled our manufacturing operations. Their consultants worked closely with our team to improve documentation, refine procedures, and ensure our systems aligned with cGMP expectations.
Head of ManufacturingBiotech Company
Our mock FDA audit with Amicus was incredibly helpful. They clearly explained where we had gaps, prioritized the issues, and offered practical ideas for fixing them. It gave our team much more confidence going into future inspections.
Director of Quality503B Outsourcing Facility
Frequently Asked Questions
A systematic approach spanning user requirements, design, procurement support, commissioning, qualification, and validation of facilities, utilities, equipment, processes, and systems. Services include commissioning documentation, IQ/OQ/PQ protocol development and execution, computerized system validation, cleaning validation, thermal mapping, and validation master planning.
Both. We develop protocols with clear objectives and acceptance criteria, execute the testing, document results, investigate deviations and prepare the summary reports for approval. We can also review and advise if your team is doing the execution.
Yes. Our computer system validation covers data integrity and system reliability in line with 21 CFR Part 11, EU Annex 11 and GAMP 5, across the full lifecycle from specification through retirement.
During planning, before equipment arrives. A validation master plan written early sets scope, priorities and resources, which keeps commissioning and qualification on schedule and avoids rework later.
Yes. Don Carter leads process and facility validation for 503B outsourcing facilities, including sterilization and thermal validation.
Through lifecycle management: ongoing monitoring, change control and scheduled periodic reviews. We can set up that program and support it over time so your systems stay in a validated state.
Related Services
503B Outsourcing Facility Compliance
GMP and inspection support for registered outsourcing facilities.
Clinical Development Quality
Phase-appropriate sponsor quality oversight from IND through commercialization.
Ready To Partner for Lasting Quality Solutions?
Let’s discuss how Amicus can support your organization’s compliance, validation, and quality objectives. Whether you’re launching a new facility, remediating FDA findings, or building quality systems, we’re here to help.