AES Service
VALIDATION AND COMPLIANCE SERVICES
From IQ/OQ/PQ and Computer System Validation (CSV) to calibration, validation documentation, and ongoing compliance support, AES helps pharmaceutical, biotechnology, medical device, and other regulated manufacturers reduce compliance risk and maintain audit-ready systems throughout the equipment lifecycle.
Helping Regulated Industries Navigate Validation with Confidence
AES provides end-to-end validation support, helping organizations reduce compliance risk, prepare for inspections, and maintain regulatory confidence throughout the validation lifecycle. Acting as an extension of your quality team, we manage projects from planning through final documentation so your internal resources can stay focused on production, research, and innovation.
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IQ
Installation QualificationVerify equipment and supporting systems are installed according to approved specifications, manufacturer requirements, and facility design documentation. |
OQ
Operational QualificationConfirm equipment and software consistently operate within established operating limits while documenting objective evidence that acceptance criteria are met. |
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PQ
Performance QualificationDemonstrate that equipment performs reliably under actual operating conditions using documented testing representative of intended use. |
CSV
Computer System ValidationValidate computerized systems used in regulated environments to ensure compliance with FDA 21 Part 11, GAMP 5, and applicable GxP requirements. Services include software lifecycle documentation, risk assessments, testing protocols, traceability, data integrity testing, electronic records validation, audit trail verification, and user access controls. |
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DOCS
Validation DocumentationDevelop complete, audit-ready documentation including: ✓Validation plans
✓Risk assessments
✓User Requirements Specifications (URS)
✓Functional Specifications (FS)
✓IQ/OQ/PQ protocols
✓Traceability matrices
✓Validation Summary reports
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CAPA
CAPA & Deviation SupportSupport investigations, deviation documentation, corrective actions, root cause analysis, and requalification following significant changes. |
When Do you need Validation?
Validation is not only required when purchasing new equipment.
Organizations commonly engage AES when they need to:
- Commission new equipment
- Validate computerized systems before production
- Prepare for FDA inspections
- Respond to FDA Form 483 observations
- Revalidate equipment following software updates or equipment modifications
- Support change control activities
- Develop compliant validation documentation
- Expand validation capacity without adding internal resources
- Perform routine requalification
Equipment & Systems We Validate
Every regulated facility is different, but one principle remains the same: if equipment affects product quality, patient safety, process consistency, or regulatory compliance, it likely requires documented validation.
- Environmental & Storage: Stability chambers, cold rooms, medical/lab refrigerators and freezers, walk-in environmental rooms
- Facility Systems: HVAC systems, cleanrooms, compressed air systems, water systems
- Process & Production: Autoclaves and sterilizers, filling machines, mixers and granulators, tablet compression and coating equipment, and cleanrooms.
- Lab & Monitoring: Laboratory instruments, environmental monitoring systems, temperature/humidity monitoring and data logging systems
- Enterprise Software Systems: Laboratory Information Management Systems (LIMS), Chromatographic Data Systems (CDS)
Built for Pharma & Biotech Quality Teams
Validation documentation that speaks your language.
Whether your quality system references GAMP 5, FDA 21 CFR Part 11, EU Annex 11, GMP, GLP, or broader GxP requirements, AES develops qualification and Computer System Validation documentation using the same structured lifecycle, traceability, and objective evidence expected by regulators and quality organizations.
GxP Terminology
- GMP: Good Manufacturing Practice
- GLP: Good Laboratory Practice
- GCP: Good Clinical Practice
- GDP: Good Documentation Practice
Three Pharma- Specific Proof Points
GAMP 5
An SDLC-based approach, not ad hoc testing. Every validation package follows a software/system development lifecycle structure — the same framework FDA reviewers expect to see, not a one-off checklist assembled after the fact.
Part 11 + EU Annex 11
Built once, aligned to both frameworks. US and EU electronic-records requirements overlap heavily; packages are built to satisfy both from the start, useful for sites with global regulatory exposure.
Data Integrity
Audit trails, e-signatures, and access control are the center, not an afterthought. Every protocol is built around the ALCOA+ principles regulators test for: attributable, legible, contemporaneous, original, and accurate records, kept complete, consistent, enduring, and available.
Traceability, mapped end to end
- Validation Plan & URS → Validation Summary Report
- Functional / Design Spec → Performance Qualification (PQ)
- Configuration Spec → Operational Qualification (OQ)
- Installation Requirements → Installation Qualification (IQ)
Lifecycle support
We support validation and compliance activities throughout the lifecycle of your regulated equipment and systems from specification and qualification through ongoing calibration, requalification, and change management.
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Purchase
Design & SelectionURS review and equipment spec confirmed against process requirements. |
Install
Installation QualificationUtilities, placement, calibration status, and documentation verified. |
Commission
OQ / PQOperating limits and real-use performance confirmed, including temperature/humidity mapping. |
Ongoing
Routine CalibrationScheduled calibration keeps instrumentation within ISO 17025 traceable tolerances. |
Annual
RequalificationReassessment against safety, regulatory, and performance standards on a risk-based schedule. |
As needed
CAPA & Deviation SupportRoot cause analysis and corrective action when a result falls outside acceptance criteria. |
Decommission
Decommissioning & RetirementFinal performance verification, data archiving, and retirement documentation to close out the compliance record. |
One partner from installation through requalification
Most providers cover one part of the validation process.
AES provides equipment qualification, Computer System Validation, calibration, environmental mapping, technical documentation, and engineering support under one roof. This reduces vendor coordination and provides a single partner throughout the equipment lifecycle.
How AES Supports You
- Lab calibration services, IQ/OQ/PQ, GXP temperature and humidity mapping, and CAPA/root-cause support under one roof — no coordinating between separate vendors for separate pieces of the validation package.
- Validation specialists fulfill three roles on every project — Project Manager, Technical Writer, and Validation Engineer — so nothing falls into a gap along the way.
- National project capacity, with the responsiveness and direct customer touch of a local partner.
- Built on existing relationships across pharma, aerospace, and regulated manufacturing customers.
Three roles AES brings to the team
- Project Manager: Owns the project end to end — drives meetings, escalates issues, and keeps resolutions on schedule.
- Technical Writer: Builds the validation document package using your existing templates, or AES-customizable ones.
- Validation Engineer: Partners with Quality to perform root cause analysis, deviation investigation, and CAPA implementation.
What Is Included in Validations Package?
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Validations Plans & URS/FS
Defines scope and approach and what the equipment is expected to do, and the right team along.
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Risk Assessment
Identifies quality and compliance risk before testing begins.
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IQ / OQ / PQ Protocols
Test procedures and pre-defined acceptance criteria for each stage.
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Traceability Matrix & Final Report
Links requirements to test results, deviations and final approval.
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Standard Operating Procedures (SOP)
SOP for the qualified equipment / validated system including but not limited to Operation, Calibration Verification and Preventive Maintenance, and System/Software Administration.
Frequently Asked Questions
Have Question? We are here to help
What is IQ, OQ, and PQ?
IQ/OQ/PQ are the three primary stages of equipment qualification. Together, they verify that equipment is installed correctly, operates within defined limits, and consistently performs for its intended use. AES develops and executes IQ/OQ/PQ protocols while providing complete documentation to support regulatory compliance.
What is equipment qualification?
Equipment qualification is the documented process of verifying that regulated equipment consistently performs according to its intended purpose. Qualification typically includes IQ/OQ/PQ, along with supporting documentation, risk assessments, and traceability.
What is Computer System Validation (CSV)?
CSV is the documented process of verifying that computerized systems consistently perform as intended while complying with GAMP 5, FDA 21 CFR Part 11, and applicable GxP regulations. CSV helps ensure data integrity, electronic record compliance, and reliable system performance throughout the software lifecycle.
How is Computer System Validation different from IQ/OQ/PQ?
IQ/OQ/PQ focuses on qualifying physical equipment, while Computer System Validation verifies that software and computerized systems function as intended and comply with regulatory requirements. Many regulated systems require both equipment qualification and CSV to demonstrate complete compliance.
Why outsource validation services?
Outsourcing validation allows organizations to expand validation capacity without diverting scientists, engineers, and quality personnel from their core responsibilities. AES provides experienced validation engineers, technical writers, and project managers to help complete projects efficiently while maintaining regulatory compliance.
What industries does AES support?
AES provides validation and compliance services for pharmaceutical manufacturers, biotechnology companies, medical device manufacturers, food and beverage producers, research laboratories, contract manufacturing organizations (CMOs/CDMOs), and other regulated industries.
Can AES develop validation protocols?
Yes. AES develops validation protocols tailored to your equipment, computerized systems, and quality requirements. Depending on the scope of your project, our team can create IQ/OQ/PQ and CSV protocols, along with supporting documentation such as Validation Plans, Risk Assessments URS, Traceability Matrices, Standard Operating Procedures (SOPs), and Final Validation Reports.
Whether you use your organization's existing templates or need AES to develop a complete documentation package, our validation specialists create audit-ready protocols that align with GAMP 5, FDA 21 CFR Part 11, GMP, and other applicable GxP requirements.