Our validated cleaning programs protect batches and operations. Defined rotations, contact times, and in-room verification keep production on schedule with audit-ready records.
We harmonize sponsor-ready programs across modalities and shared suites. Clear changeovers and traceable documentation reduce idle time and keep campaigns moving.
We support sterile and non-sterile compounding with standards-aligned workflows. Segregated tools, defined rotations, and verification enable safe release and clear records.
We service hot labs and production suites with shield-friendly methods. Targeted cleaning, rapid turnarounds, and clear documentation keep time-sensitive work on track.
We build flexible programs around experiments and instrument schedules. Routine upkeep and one-time resets protect equipment and provide documentation for QA and sponsors.

Our validated cleaning programs ensure consistency, traceability, and compliance in every room, shift, and site, maintaining production on schedule.

We design and validate organism-specific decontamination programs that restore operations safely and withstand regulatory scrutiny.

From contamination incidents to shutdown recovery, our decontamination teams deliver validated results and complete regulatory documentation.

We build specialized service packages aligned to your production schedule — minimizing disruption, stabilizing costs, and ensuring audit-ready results.

We strengthen contamination control programs with aligned systems, clear records, and trained teams, so every inspection runs smoothly.

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Audit & Compliance Support

Audit & Compliance Support

Audits don’t have to mean stress, long nights, or preventable findings. With the right systems and records, inspections can run smoothly and give your team confidence. 

We provide the structure and documentation you need to stay audit-ready. That includes risk-based contamination control strategies, clear operating procedures, and accurate, inspection-ready records. 

The result is fewer audit findings and smoother inspections, without slowing down the floor.

Why Audit & Compliance Support Is Critical

In GMP-regulated facilities, audit pressure is constant and standards continue to evolve. Over time, procedures and records are often created in silos, drafted by different people at different moments. The result is documentation that does not align, and controls that appear solid on paper but fail in practice.

Our audit and compliance support helps you close those gaps. We build systems QA can stand behind, Operations can follow, and regulators can understand. With our support, you walk into every inspection with confidence instead of concern.

Who We Serve

Audit and compliance requirements touch every function. Each team benefits differently from our support:
QA and Regulatory gain fewer gaps, clearer traceability, and confidence that their records will stand up in an audit.
Operations gain practical controls that fit daily work, reducing bottlenecks and end-of-shift disruptions.
Engineering and Facilities gain workable flows, clean change control, and equipment compatibility.
Leadership and Procurement gain lower audit risk and a prioritized remediation roadmap with clear owners and timelines.

What To Expect From Our Process

Audit and compliance readiness is not a single event. It is a process that builds confidence step by step. Our structured approach takes you from discovery to audit day with systems that hold up under pressure.

Discover & Design

We start by walking through your processes, interviewing staff, and reviewing key records. This creates a clear picture of how work is being done and maps your existing controls to risk.

Gap Assessment

We benchmark your practices against regulatory standards and corporate requirements. You receive a prioritized list of issues, giving you a clear plan of where to focus.

Remediation Design

We rewrite or right-size SOPs, redesign records and templates, and develop training that is practical and effective. Where necessary, we add process checks to ensure gaps are fully closed.

Enablement

Before rollout, we prepare your team with training, rehearsals, and friction-point fixes. This ensures the new system works smoothly on the floor and is fully adopted.

Final Audit Prep

We get you ready for audit day with a mock audit, readiness memo, evidence index, and coached SMEs. The goal is a shorter, smoother inspection and a confident team.

Pillars We Build On

Our approach is built on key pillars that create lasting readiness:
Risk Orientation

Controls are aligned to risk, not the other way around.

Documentation Rigor

Templates and logs designed for accuracy, even under time pressure.

Adoption First

If the floor cannot execute, the system will not survive an audit. We design for real-world use.

Continuity

Regular reviews, change-control hooks, and training refreshers maintain long-term compliance.

The Value of Audit & Compliance Support

Vibraclean’s programs bring stability and confidence to a range of regulated environments:

New facilities that need compliance systems built from the ground up.

Sites preparing for upcoming regulatory changes or corporate harmonization across multiple locations.

Facilities recovering from past audit findings or preparing for upcoming agency or third-party inspections.

What You Receive With Our Solutions

Every engagement produces deliverables you can put to work immediately:

A Gap Report and Risk Register 
with prioritized fixes.

Reworked SOPs and Records, 
including templates, examples, and
 guidance notes.

Training Materials with
 competency checks.


A Readiness Packet with an evidence index, mock findings 
with responses, and SME briefs.

A Sustainability Plan with review cycles, metrics, and clear ownership.

Proven Results You Can See

The results of our audit and compliance support are visible in both metrics and daily operations.

Facilities report fewer audit observations tied to cleaning and contamination control. Records are retrieved faster and traced more clearly during inspections. Audit findings close faster and stay closed, preventing repeat issues. 

Most importantly, your teams spend less time scrambling and more time working with confidence, knowing they are prepared for every inspection.

Tailored Solutions

Custom cleaning and disinfection programs designed for your facility’s unique compliance needs.

25+ Years Expertise

Decades of proven experience delivering critical disinfection across regulated industries.

10+ Years Research

Extensive particle and bio-burden control expertise across multiple industries.

Proof in Practice

The impact of our cleanroom cleaning and disinfection solutions is clear. Facilities see fewer cleaning-related issues, smoother inspections, and more productive hours for their internal specialists. Records are retrieved faster, with fewer clarifications needed. Internal specialists gain more productive hours. Costs stabilize without end-of-month labour spikes. Most importantly, your teams stop scrambling and start working with confidence, knowing they are always ready for inspection day.

Tailored Solutions

Custom cleaning and disinfection programs designed for your facility’s unique compliance needs.

25+ Years Expertise

Decades of proven experience delivering critical disinfection across regulated industries.

10+ Years Research

Extensive particle and bio-burden control expertise across multiple industries.

Get Started with Precision Cleanroom
Cleaning & Disinfection.

Getting started is simple. Talk with our experts about the challenges you are facing today or the risks you want to get ahead of tomorrow. We will design a program that delivers stability, compliance, and confidence without disrupting production.