20 years of Excellence

Omni-Assistant
eQMS

Selecting the Omni-Assistant eQMS provides a Next-Gen platform shaped by two decades of ongoing improvements, now enhanced with AI capabilities and advanced analytics.

The Omni-Assistant eQMS features a design specialized for laboratories and the healthcare sector. Backed by a track record of thousands of successful audits, there is no substitute for experience.

Omni-Assistant AI Assistant
Platform

15 fully integrated modules

One software. One solution.

Now enhanced

AI capabilities & advanced analytics

Built for
  • Quality
  • Compliance
  • Risk Management
Omni-Assistant AI audit readiness checklist

BE Audit-Ready
@ all times

Whether you manage a hospital laboratory, medical imaging center, pharmacy, stem cell transplant program, fertility clinic, veterinary diagnostics service, food laboratory, or environmental laboratory, the Omni-Assistant eQMS is your all-in-one solution for quality management. It is highly intuitive, fully integrated, streamlined and optimized to support best business practices with full quality compliance to regulatory bodies.

15 Fully Integrated Modules
120+ Laboratory & Healthcare Standards
650+ Hospitals
450+ Laboratories
99.99% Availability Track Record

120+ Lab and Healthcare standards

Laboratories: Shift from “Preparing for Audits” to Audit-Ready @ all times.

Stop wasting weeks scrambling before inspections. Omni-Assistant eQMS embeds continuous compliance with AI-gap analysis directly into your audit workflows.

Medical and clinical laboratory technician handling test samples
ISO 15189

Medical And Clinical Laboratories.

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Veterinary and animal health laboratory technician using a microscope
ISO 17025

Veterinary & Animal Health Laboratories.

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General testing and calibration laboratory with technicians at workstations
ISO 17025

General Testing And Calibration Laboratories.

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Other Laboratory Standards

Clinical Laboratory Improvement Amendments — mandates quality standards for all testing performed on human specimens for diagnosis, prevention, or treatment in the USA.

Administered by the College of American Pathologists (CAP), this voluntary but widely adopted program is accepted by CMS as meeting or exceeding CLIA standards.

Provides deemed-status laboratory accreditation based on national patient safety goals and CLIA compliance.

Applies to laboratories that manufacture their own in-house tests (Laboratory Developed Tests / LDTs) and non-clinical trial studies requiring cGLP (Current Good Laboratory Practices — 21 CFR Part 58).

American Association of Blood Banks standards for transfusion medicine, cellular therapies, and relationship testing.

Canada Occupational Health and Safety Regulations — establishes workplace hazard and safety standards for laboratory personnel.

Standard for the application of risk management to medical laboratories.

Establishes requirements for the collection and transport of samples for medical examinations.

Specifies requirements for medical laboratory safety.

Decontamination and reprocessing of reusable medical devices.

Ensures compliance with Health Canada’s Blood Regulations.

Specifications for cell handling and storage.

Sets the benchmarks for professional responsibility, competency, and ethics for medical laboratory professionals in Canada.

Other Healthcare standards

01
CAN/HSO 42002

For Diagnostic Imaging Services, for hospitals and private clinics in Canada.

02
ISO 15189+ for Diagnostic Imaging

For hospitals and private clinics in Canada.

03
CSA Z314

Decontamination and reprocessing of reusable medical devices.

04
FACT

Cellular therapies are governed by strict regulatory frameworks and international professional standards to ensure product safety, quality, and efficacy.

05
WMDA

International guidelines established by the World Marrow Donor Association for the collection, processing, and distribution of hematopoietic stem cells.

06
ASHI

Requirements established by the American Society for Histocompatibility and Immunogenetics to evaluate and accredit clinical laboratories performing histocompatibility, immunogenetics, and transplantation testing.

07
PIC/S GMP

Good Manufacturing Practice standard for medicinal products, ensuring pharmaceutical manufacturers produce safe, high-quality human and veterinary drugs through standardized inspections.

08
NAPRA

Canadian standards regulating the pharmacy profession and supporting patient and compounding-personnel safety.

Seamless Crosswalk Capabilities and
Limitless Standards Support

Source ISO 15189
Source ISO 17025
Source CLIA
Source CAP
Crosswalk Output

Consolidated Compliance Status

Individual Standards Multiple Standards Intersections Overlaps
Current Compliance Status
Is your organization required to comply with numerous compliance standards?

The Omni-Assistant eQMS is engineered to accommodate individual or multiple regulatory standards simultaneously. In cases where these standards intersect or overlap, our advanced crosswalk capability delivers a consolidated overview of your current compliance status, helping you reclaim invaluable operational hours.

Don’t see your specific framework listed above?

Given the extensive variety of frameworks we manage, it is impossible to feature them all here; however, we likely support your specific requirements already.

Lab technician reviewing electronic records on a tablet

Health Canada,
FDA 21 CFR Part 11,
PIC/S Annex 11

Do you need strict, legally binding controls for electronic records and signatures?

01
Immutable Audit Trail

Every action is logged.

02
Electronic Signatures

Strict, multi-factor-linked digital signatures that bind user identity to document actions.

03
Dual-Witness Verification

Manifest-linked double approvals required for high-risk changes, such as modifying a testing method.

Ask us about the Part 11 package
Implementation

Fast Track Your eQMS Implementation

No worries, we got you covered. We can bulk import your information and get you up and running in a matter of days.

Ask us about the fast track
Return on Investment

A Rapid Return on Investment (ROI)

With budget-friendly pricing that ensures the Omni-Assistant eQMS is accessible to any organization, a full ROI is realized rapidly, typically within just 3 months.

Contact us Today

Become Audit-Ready at All Times

Speak with the Omni-Assistant team about your compliance standards, implementation requirements and quality-management goals.

Omni-Assistant AI Assistant