What Clients

Are Saying

“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 resulting in less stress overall. The inspection was a success. We received our commercial license, and AuditUtopia™ was a big part of achieving that milestone.”

EJ Brandreth

Vice President of Quality & Regulatory
Inovio Pharmaceuticals Inc.

Inovio Pharmaceuticals Inc

“I have had nothing but great experience with ACE™ since we first implemented our first workflow in January of 2016. There were many people who were not comfortable with it, but have adjusted and cannot believe we were without it. PSC Biotech™ has been an essential part of our growth. They are always willing to help and have taken the time to explain on how to code workflows, or special requests.”

Cynthia Samera

Validation Engineer Supervisor
Kleen Test Products

Working at Kleen Test Products in Port Washington, WI: 70 Reviews ...

“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 stream-line 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.”

Jeff Yuen

Former Commander
Food and Drug Administration

“ACE™ is a very user friendly software which allows you the flexibility to carry out multiple processes on a single platform which is otherwise done through systems like Trackwise, SAP, LIMS, etc. making it very easy and convenient to use.”

Faizan Syed

Senior Process Engineer,
AstraZeneca

13 AstraZeneca - Contract Pharma

“We love AuditUtopia™ and with 2 major inspections looming, we will be utilizing it big time in 2019.”

Marta Fields

Senior Director, R&D Quality
Seattle Genetics

“ACE Essentials™ QMS has been a great system to work with. We’ve found that the system strikes a good balance between ease of use and comprehensive QA coverage. We’ve also had plenty of help from ACE™ whenever we required it. For a company and staff that’s still getting their heads around everything required in quality systems, ACE Essentials™ has been a valuable tool.”

Josh Rabinowitz

Co-Founder & CEO
Articulate Labs

Our Portfolio | Health Wildcatters 

“ACE™ is very unique software which can be used to write/initiate records/deviations and at the same time this software can be used for Material Management & QC Sample Management. It’s like having many functions in one software. My overall experience was very good. This software is compliant with all industry regulations and can be easily optimized. There are many occasions I got some issues, they are fixed quickly to suit the process.”

Verified Reviewer on Capterra

“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!”

Steve Lawson

Senior Quality Assurance Engineer
Biomedical Manufacturer

“Web-based, so you can access documents from anywhere on any platform. Simple UI that is intuitive and easy to navigate. Highly modular and customizable to your specific business needs. I would strongly recommend this software to any company with GMP operations.”

Verified Reviewer on Capterra

“Easy to setup dashboard to monitor close out of documents. Allowed for easy management of all quality related documents. Was able to adapt to other functions such as receipt of materials and capture data.”

Chris Sebranek

Director Quality
LSNE

LSNE Completes Acquisition of Sterile Injectables Manufacturing ...

“The software is intuitive and forgiving. One stop shop for your compliance needs – authoring of sops, training compliance, capas ,etc. Using ACE™ solved the problem of buying, integrating and maintaining multiple systems for necessary compliance. One password, one system.”

Verified Reviewer on Capterra

“ACE™ is absolutely the most configurable EMS platform you will find. It is the type of system that becomes your most trusted system of use and record; and which is a force multiplier for efficiency, speed of information, knowledge preservation, document management, SOP development, and countless other activities particular to your industry.”

Verified Reviewer on Capterra

“I love the ability of AuditUtopia® to manage more parts of the audit process all at once. The real time request management system is a great tool!”

Dan McGrath

Microbiologist
Medtronic

Medtronic issues safety notice after Mazor X detachments

“ACE™ made it easy to take everything digital and stop using old paper validation systems. ACE™ is very intuitive and easy to use while still offering all the functionality you need.”

Verified Reviewer on Capterra

“Allows for very efficient way of managing audits. Audit summary is actually completed at end of audit without the need to draft an audit report.”

Chris Sebranek

Director Quality
LSNE

LSNE Completes Acquisition of Sterile Injectables Manufacturing ...

“AuditUtopia® is a highly configurable platform that provides the user the means to maintain continuous audit readiness (from materials, systems, equipment, training, certification, personnel, self testing, quality control, etc.). Time and again, with auditors from the FDA and other compliance agencies, the audits (whether planned or surprise audits) went off wihtout a hitch. AuditUtopia®’s GUI from an auditor’s perspective is simply the best you will find. The ability to capture all required information (SOPs, Policy Document, Training Records, Equipment Maintenance Logs, Safety Inspections, Certifications) in a graphic medium, provides visual evidence that makes the auditor’s job easist. Gone are the days of ruffling through paper training records, invoices, manufacturing logs. All required information is at the auditor’s fingertips. AuditUtopia® is now the Gold Standard among platforms of its kind.”

Verified Reviewer on Capterra

“Functionality – AuditUtopia® is as advertised. The core functions of AU could be handled by juggling several apps, but AU brings everything together in one place (audit trail, audit notes, document requests). If you are regularly under audit (such that everything might blend together), this will keep everything nice and organized and reviewable later.”

Verified Reviewer on Capterra

“Fast and easy setup – we were up and running for our first mock audit within a few hours. Intuitive interface for users – the core functionality (scribing / backroom visibility / document request tracking) have been the features we have focused on.”

Verified Reviewer on Capterra