AVEX service

Decommissioning & Requalification Services

Managing the Complete Lifecycle of GMP Facilities, Equipment, and Validated Systems

Life
Complete asset lifecycle
GMP
Records built for quality review
Life
Startup through sustained ownership
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LifeRequalification

The service, end to end

Requalification — from problem to delivery.

Many organizations invest heavily in commissioning and qualification but underestimate the importance of maintaining validated systems throughout their operational life. Equipment modifications, software upgrades,...

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Why it matters

Retire, modify, requalify, and maintain validated systems without losing compliance control.

Capsule visual representing controlled GMP asset lifecycle management

The problems we remove

Manufacturing assets eventually reach the end of their useful life. Replacing or retiring equipment requires impact assessments, documentation updates, and controlled implementation to...

Capsule visual representing controlled GMP asset lifecycle management

How AVEX runs it

Real delivery steps AVEX engineers own end to end - planning, design review, commissioning, qualification, and turnover - not a generic four-box diagram.

Regulatory alignment

Standards this program is built around.

FDA Current Good Manufacturing Practice (cGMP)21 CFR Parts 210 & 21121 CFR Part 11EU GMP Annex 15ISPE Baseline GuidesGAMP 5ASTM StandardsICH Q9 - Quality Risk ManagementICH Q10 - Pharmaceutical Quality SystemISO 13485 (where applicable)FDA Current Good Manufacturing Practice (cGMP)21 CFR Parts 210 & 21121 CFR Part 11EU GMP Annex 15ISPE Baseline GuidesGAMP 5ASTM StandardsICH Q9 - Quality Risk ManagementICH Q10 - Pharmaceutical Quality SystemISO 13485 (where applicable)

Frequently asked

Answers before you pick up the phone.

What is equipment decommissioning?

Equipment decommissioning is the structured process of safely retiring manufacturing equipment or computerized systems while maintaining regulatory compliance, preserving historical records, and minimizing operational risk.

When is requalification required?

Requalification is typically required after major equipment modifications, facility renovations, software upgrades, equipment relocation, extended shutdowns, significant maintenance activities, or at predefined periodic intervals.

Does AVEX support annual requalification programs?

Yes. We develop and execute annual and periodic requalification programs for manufacturing equipment, controlled temperature units, HVAC systems, clean utilities, laboratories, and environmental monitoring systems.

Can AVEX support facility shutdown projects?

Absolutely. We assist clients with facility decommissioning, equipment retirement, utility isolation, documentation updates, computerized system retirement, and project closeout activities.

How does AVEX manage change control during decommissioning?

Our consultants integrate closely with client quality systems by performing change impact assessments, risk evaluations, validation planning, documentation updates, and final change closure support.

In summary

Extend the Life of Your Validated Assets with Confidence

Maintaining compliance throughout the lifecycle of manufacturing facilities requires more than successful startup-it demands disciplined engineering, structured change management, and continuous validation support....