Inspection Management

Solutions for Your Regulatory Inspection and Audit Needs

Looking for a less stressful, more successful backroom audit management process? Having an inspection management platform that can streamline your organization’s activities all within a single solution will not only reduce stress during your regulatory inspections but can help ensure that you pass your inspections by helping you put your best foot forward.

auditutopia

In highly regulated industries, you can count on the fact that your company will be inspected a time or two. AuditUtopia® captures, tracks, communicates, and sorts audit activities as a real-time Inspection Audit Management System used to host inspections and audits that is trusted by life science companies worldwide. With AuditUtopia®, you can streamline your inspection process, improve response time for requests and lead end of the day meetings. Many organizations choose AuditUtopia® as the center of their inspection team to seamlessly streamline group efforts to improve response time for inspection requests. 

ACE Inspection® software as a service allows companies like yours to completely control and manage your Inspections without worry all while being handled remotely. ACE Inspection® software as a service is a highly configurable, workflow-based software that can adapt to any business process, allowing for document sharing, management, and reporting of all compliance, quality, and operational activities. With ACE Inspection® software as a service, you will minimize the hassles of Inspections and be able to focus on what matters most, your company’s work.

 

Best Suited for Small to Mid Size Companies

  • Remote and Onsite Inspection Supported
  • Scribe Note Tracking
  • Request Fulfillment
  • Dashboards and Reports
  • Limited Configurations
  • Minimal Integrations
  • No File Sharing

Best Suited for Mid to Large Size Companies

  • Remote and Onsite Inspection Supported
  • Scribe Note Tracking
  • Request Fulfillment
  • Dashboards and Reports
  • Full Configurations
  • Full Integrations
  • Built-in File Sharing

 

What Our Clients are Saying

“Successful FDA inspections are dependent on having a combination of seasoned individuals responsible for hosting, note-taking, and running requests back and forth from the conference room. AuditUtopia® has been tested during my simulated FDA mock inspections and it serves to overall streamline the inspection process. As a former FDA investigator, I fully endorse AuditUtopia® and recommend it to any company working in a regulated industry. It will impress any FDA investigator that comes to your facility for an inspection. Successfully managing FDA inspections is the bottom line.”

“A regulatory audit is a unique event for all involved. To manage a successful audit, the organization needs a thoughtful plan, well-defined roles with skilled and experienced personnel, and an effective mechanism for communication. In my experience, the most effective integrated software tool available for the latter is AuditUtopia®. It is a software application designed and dedicated to optimize the avenues of communication that a company should have in place to answer the auditor’s questions, and provide the required objective evidence – in a timely manner. The software itself does not answer the auditor’s questions, it enables the right resources within the company to answer them. After having installed and actively used AuditUtopia® for multiple intense regulatory audits, I would not want to be without it!”

“I just want to express my appreciation for your impressive AuditUtopia® program. During a recent PAI inspection from the FDA we were challenged with 211 requests for documents. I do not know how we would have managed without the AuditUtopia® software. Our Quality staff was able to execute FDA requests rapidly and flawlessly, communicate in real-time between the various groups, and all of this resulted in less stress overall. The inspection was a success. We received our commercial license, and AuditUtopia® was a big part of achieving that milestone.”

“The overall flow of the audit is smoother, and we have received compliments from our clients about how much our audit process has improved.”

-KaylaHarris,QualityAssurance ProjectManager (HowThermoFisherScientific StreamlinedInspection ManagementWithAuditUtopia®)

“The training process was thorough. Our trainer was very knowledgeable and gave us a recording of the training so we could train future employees and off-site employees on the utility of the program.”

-Cameron Jones, Head of VVS Quality Compliance & Regulatory (How Thermo Fisher Scientific Streamlined Inspection Management With AuditUtopia®)

 

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Client Success Stories

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Prepare For Inspections

The client wanted to streamline inspection activities and prepare for regulatory inspections. AuditUtopia® was able to achieve their goals.

quality management software

Manage All Regulatory Inspections

This client is now successfully utilizing our software, AuditUtopia® to manage all of their regulatory inspections and third party audits, as intended.

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Transitioning to a Full Electronic System

This client had previously been using multiple systems to manage inspections, so they were excited to transition to a full electronic system.

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