Compliance Standards

Healthcare

CDC Vaccine Storage

The CDC Vaccine Storage and Handling Toolkit provides comprehensive guidance on maintaining vaccine potency and safety through proper storage practices. Vaccines are temperature-sensitive products that lose potency when exposed to improper temperatures. Healthcare facilities, pharmacies, and immunization programs must implement strict storage and handling protocols to ensure vaccine efficacy and patient safety. ATEK's environmental monitoring platform helps organizations meet CDC requirements by providing continuous temperature monitoring, automated alerts, and complete documentation of vaccine storage conditions.

AABB, the Association for the Advancement of Blood & Biotherapies, establishes accreditation standards for blood banks, transfusion services, and plasma centers throughout the United States and internationally. AABB accreditation requires continuous temperature monitoring, comprehensive alarm systems, and 24/7 response capability to ensure blood product viability and patient safety. These critical requirements protect the integrity of life-saving blood products used in transfusions and medical procedures. ATEK's monitoring platform helps blood banks meet AABB requirements through continuous monitoring, multi-condition alarms, calibrated sensors, and 24/7 alert capabilities.

Pharmaceutical

USP 797

USP General Chapter 797 establishes standards for compounding sterile preparations to help ensure patient safety. ATEK's environmental monitoring solutions help pharmacies maintain the controlled conditions required for sterile compounding.

State Boards of Pharmacy across all U.S. states establish regulations for medication storage, temperature control, and documentation to ensure medication efficacy and patient safety. These regulations apply to retail pharmacies, hospital pharmacies, compounding pharmacies, and specialty pharmacies. Compliance requires maintaining specific temperature ranges for different medication types, documenting daily temperature checks, retaining records for 3 years, and managing temperature excursions appropriately. ATEK's monitoring platform helps pharmacies meet state board requirements across all 50 states through multi-zone temperature monitoring, automated documentation, NIST-traceable sensors, and comprehensive record retention.

The College of American Pathologists (CAP) establishes accreditation standards for clinical laboratories, pathology labs, and reference laboratories across the United States. CAP accreditation requires strict temperature monitoring and documentation for all laboratory equipment storing temperature-sensitive materials. These requirements ensure laboratory results are reliable, tests remain valid, and patient care is protected. ATEK's monitoring platform helps laboratories meet CAP temperature monitoring requirements through automated documentation, calibrated sensors, and comprehensive record retention.

Pharmaceutical

21 CFR Part 11

FDA 21 CFR Part 11 establishes the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and generally equivalent to paper records and handwritten signatures. ATEK's environmental monitoring platform is designed from the ground up to help organizations achieve and maintain compliance with these critical regulations.

Pharmaceutical

USP 1079.4

USP General Chapter <1079.4> provides guidance on temperature mapping to qualify drug product storage areas — from small refrigerators and freezers to large warehouses. This chapter applies to every link in the supply chain from manufacturer through distribution, with the sole exception of the patient. It does not cover shipping or transportation. ATEK's monitoring platform supports the full mapping lifecycle from probe placement through final protocol reporting.

Pharmaceutical

USP 800

USP General Chapter 800 establishes standards for safe handling of hazardous drugs to protect healthcare workers, patients, and the environment. ATEK's environmental monitoring helps facilities maintain the negative pressure containment required for hazardous drug handling.

Joint Commission Standard PC.17.10 establishes requirements for tissue storage and issuance in accredited hospitals, surgical centers, and transplant programs. This critical standard ensures tissue products used in surgical procedures are maintained at optimal conditions to preserve viability and safety. Facilities must implement continuous temperature monitoring, maintain comprehensive records, and respond immediately to storage deviations. ATEK's monitoring platform helps organizations meet all PC.17.10 requirements through automated continuous monitoring, multi-channel alerts, daily documentation, and long-term record management.

Healthcare

Ontario Vaccine Guidelines

The Ontario Vaccine Storage and Handling Guidelines establish provincial requirements for cold chain management as part of the Ontario Public Health Standards framework. These guidelines apply to all Ontario healthcare providers storing and administering publicly funded vaccines. ATEK's monitoring solutions help Ontario providers maintain compliance while protecting valuable vaccine inventory.

Healthcare

NVSAG (Canada)

Canada's National Vaccine Storage and Handling Guidelines establish essential requirements for protecting vaccine integrity and effectiveness throughout the cold chain. Administered by the Public Health Agency of Canada (PHAC), these guidelines are critical for maintaining public trust in immunization programs and preventing disease outbreaks. ATEK's environmental monitoring platform is purpose-built to help healthcare facilities, pharmacies, and immunization clinics achieve continuous compliance with these stringent requirements while maintaining the highest standards of vaccine security and patient safety.

Pharmaceutical

GUI-0119

Health Canada's GMP Guidelines for Sterile Drug Products establishes comprehensive requirements for the manufacture of sterile pharmaceutical products. These guidelines ensure that sterile drugs are produced in a controlled manner to minimize contamination risks and maintain product quality and safety. The guidelines cover facility design, environmental monitoring, personnel controls, and manufacturing processes specific to sterile product production. ATEK's environmental monitoring platform is designed to support organizations in maintaining compliance with these critical requirements through continuous monitoring, documentation, and reporting of environmental conditions.

Healthcare

CSA Z902

CSA Z902 is the Canadian standard for blood and blood components, establishing requirements for collection, testing, processing, storage, and distribution. ATEK's monitoring solutions help blood banks and transfusion services maintain the strict temperature control required to ensure blood product safety.

Pharmaceutical

OPQ Magistrales Non Stériles

The Ordre des pharmaciens du Québec (OPQ) establishes comprehensive standards for the preparation of non-sterile magistral compounds in community and hospital pharmacies throughout Quebec. These standards ensure that compounded preparations meet rigorous quality and safety requirements, protecting patient safety while preserving the professional judgment of pharmacists. ATEK's environmental monitoring solutions help Quebec pharmacies maintain the documented conditions required for compliant non-sterile compounding operations.

Healthcare

PHAC Vaccine Guidelines

The National Vaccine Storage and Handling Guidelines published by the Public Health Agency of Canada (PHAC) establish the national standard for vaccine cold chain management across all Canadian jurisdictions. ATEK's monitoring solutions help healthcare providers maintain compliance with these federal guidelines while protecting valuable vaccine inventory.

Pharmaceutical

GUI-0069

Health Canada GUI-0069 provides environmental control guidelines for the storage and transportation of pharmaceutical products in Canada. These guidelines establish the requirements for monitoring, controlling, and documenting environmental conditions including temperature and humidity to ensure product quality, safety, and efficacy throughout the supply chain. ATEK's environmental monitoring platform is specifically designed to meet or exceed these guidelines through continuous monitoring, automated compliance documentation, and comprehensive data management.

Pharmaceutical

GUI-0066 Annex 7

Health Canada's GUI-0066 Annex 7 establishes Good Manufacturing Practice (GMP) guidelines specifically for selected non-prescription drugs in Canada that bear a Drug Identification Number (DIN) and appear on the List of Non-Prescription Drugs Not Subject to Certain Testing Requirements. Covering product categories such as toothpastes, mouthwashes, sunscreens, antiperspirants, throat lozenges, anti-dandruff products, acne treatment products, athlete's foot treatment products, diaper rash treatment products, antiseptic skin cleansers, and medicated skin care products, this annex provides modified interpretations of the parent guide GUI-0001. ATEK's environmental monitoring platform provides the technical infrastructure necessary to achieve and maintain compliance with these GMP requirements through continuous monitoring, automated documentation, and comprehensive data management.

Pharmaceutical

GUI-0050 Annex 11

Health Canada's GUI-0050 Annex 11 provides detailed guidance on the application of Good Manufacturing Practices (GMP) to computerized systems used in pharmaceutical, radiopharmaceutical, biological, and veterinary manufacturing. This guidance was adopted from PIC/S PE-009-15 Annex 11: Computerised Systems, ensuring that Canadian manufacturers meet internationally recognized standards for data integrity, security, and system validation. ATEK's environmental monitoring platform is designed to help organizations achieve and maintain compliance with these comprehensive requirements.

Healthcare

BCCDC Immunization

The BCCDC Immunization Program establishes cold chain management requirements for all vaccine storage in British Columbia. ATEK's monitoring solutions help BC healthcare providers maintain compliance with provincial guidelines and protect vaccine inventory.

Healthcare

Quebec PIQ

The Guide des normes et pratiques de gestion des vaccins is Quebec's official reference for vaccine quality standards. Published by the MSSS, it establishes requirements from manufacturer to administration. ATEK helps Quebec healthcare providers maintain compliance with provincial cold chain requirements.

Healthcare

Alberta Vaccine Policy

The Alberta Vaccine Storage and Handling Policy establishes provincial requirements for cold chain management of provincially funded vaccines. Based on national PHAC guidelines, this policy applies to all Alberta Health Services sites, community providers, and pharmacies. ATEK's monitoring solutions help Alberta healthcare providers maintain compliance while protecting valuable vaccine inventory.

Healthcare

Health Canada Blood Regs

The Health Canada Blood Regulations Guidance Document establishes the federal requirements for establishments that collect, process, store, and distribute blood and blood components in Canada. These regulations work in conjunction with CSA Z902 to ensure the safety and quality of Canada's blood supply. ATEK's monitoring solutions help blood establishments maintain compliance while protecting valuable blood products.

Laboratory

CSA Z316.7-12

CSA Z316.7-12 is a Canadian standard that establishes requirements for the collection of specimens for clinical laboratory testing. The standard ensures specimen integrity from collection through analysis by defining procedures, documentation requirements, and quality control measures. ATEK's laboratory information management system provides the technological infrastructure needed to implement and maintain compliance with CSA Z316.7-12 requirements throughout the specimen lifecycle.

Laboratory

QC Transport Guide

The Quebec Guide to Transport and Storage of Medical Biology Samples establishes standards for maintaining sample integrity and quality during transport throughout the province. Issued by the Ministère de la Santé et des Services sociaux (MSSS), this guide is essential for clinical laboratories, hospital networks, and diagnostic centers to ensure reliable test results. ATEK's temperature monitoring platform helps organizations meet Quebec's transport requirements through continuous monitoring, documentation automation, and real-time alerts that prevent costly sample degradation.

Research

CCAC HVAC Guidelines

The CCAC HVAC Guidelines establish Canadian standards for environmental control in laboratory animal facilities. These performance-based guidelines ensure animal welfare through proper temperature, humidity, and air quality management. ATEK's monitoring solutions help research institutions maintain compliance while protecting animal welfare and research integrity.

Research

CCAC Fish Guidelines

The CCAC Guidelines on the Care and Use of Fish establish Canadian standards for humane care of fish in research. These guidelines cover monitoring of critical parameters including dissolved oxygen, temperature, pH, ammonia, nitrites, salinity, and total gas pressure. ATEK solutions help institutions maintain optimal conditions for fish welfare and regulatory compliance.

Pharmaceutical

OPQ Steriles Dangereux

The Ordre des pharmaciens du Québec (OPQ) has established rigorous standards for the preparation of hazardous sterile drugs to protect pharmacy personnel, patients, and the environment. These standards require specialized facilities, engineering controls, and rigorous procedural adherence. ATEK's environmental monitoring platform helps Quebec pharmacies maintain compliance with OPQ requirements through continuous monitoring of critical environmental parameters.

Pharmaceutical

OPQ Stériles Non Dangereux

The Ordre des pharmaciens du Québec (OPQ) establishes comprehensive standards for the preparation of non-hazardous sterile compounds in Quebec. These standards ensure that compounded preparations meet the same quality, safety, and efficacy standards as commercially manufactured products. ATEK's environmental monitoring solutions help Quebec pharmacies maintain the controlled conditions required for compliant sterile compounding.

Laboratory

Quebec Lab Quality Guide

The Guide de gestion de la qualité des laboratoires de biologie médicale establishes the quality management standards that all medical biology laboratories in Quebec must follow. Published by the Ministère de la Santé et des Services sociaux du Québec (MSSS), this guide ensures laboratories maintain high standards for specimen handling, equipment management, and result accuracy to protect patient safety and diagnostic reliability.

General

FD X 07-013

FD X 07-013 is a French guidance document (fascicule de documentation) published by AFNOR that helps organizations choose between calibration and verification for their measurement equipment, and manage the resulting measurement data. It complements the parent standard NF X 07-010 by providing criteria for selecting the appropriate metrological operation based on equipment criticality, and guidance on exploiting, storing, and retaining measurement results. ATEK's calibrated sensors and integrated monitoring solutions directly support FD X 07-013 compliance by providing traceable calibration certificates, measurement uncertainty data, drift monitoring, and comprehensive record keeping.

Laboratory

FD X 15140

FD X 15-140 is a French guidance document (fascicule de documentation) published by AFNOR that defines recommended methods for the characterisation and verification of climatic and thermostatic chambers used in laboratory and research environments. This document provides guidance on measurement methodology, spatial uniformity assessment, stability evaluation, and verification of enclosures controlling temperature alone or temperature and humidity together. ATEK's environmental monitoring platform provides comprehensive tools and capabilities to support alignment with FD X 15-140 recommendations through continuous monitoring, automated analysis, and detailed documentation.

EU GMP Annex 1 (revised 2022) sets the European standard for the manufacture of sterile medicinal products. The revision introduced the Contamination Control Strategy (CCS) as a central requirement and significantly strengthened environmental monitoring obligations. Annex 1 applies to all manufacturers of sterile products sold in the EU, including those manufacturing outside Europe. ATEK's environmental monitoring platform helps pharmaceutical manufacturers meet the stringent monitoring, documentation, and data integrity requirements of Annex 1 through continuous monitoring, automated alerting, and audit-ready reporting.

Pharmaceutical

ISPE Temperature Mapping

The ISPE Good Practice Guide for Controlled Temperature Chamber Mapping provides comprehensive recommendations for designing, executing, and documenting temperature uniformity studies in pharmaceutical manufacturing and storage environments. These studies are critical for demonstrating that controlled chambers maintain the required temperature ranges throughout the chamber volume. ATEK's environmental monitoring platform is designed to support all aspects of temperature mapping studies, from multi-point data collection through comprehensive analysis and regulatory-compliant documentation.

Healthcare

ISO 13485

ISO 13485 is the international standard for quality management systems in the medical devices industry. It establishes requirements for companies to design, manufacture, and distribute medical devices that consistently meet customer needs and regulatory requirements. ATEK's environmental monitoring platform helps organizations establish and maintain the documented control of environmental conditions essential to ISO 13485 compliance, from manufacturing facilities to storage and distribution networks.

Laboratory

ISO 17025:2017

ISO 17025:2017 establishes general requirements for the competence, impartiality, and consistent operation of laboratories conducting testing and calibration work. It is the primary international standard recognized for laboratory accreditation worldwide. ATEK's environmental monitoring solutions support ISO 17025 compliance by providing precisely calibrated sensors, comprehensive traceability documentation, and management systems that document adherence to all metrological and quality requirements.

General

ISO 9001

ISO 9001 is the globally recognized standard for quality management systems, defining requirements for organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements. ATEK's comprehensive platform provides the tools, documentation capabilities, and monitoring infrastructure needed to establish, implement, and continuously improve a robust quality management system across any industry.

Laboratory

ISO 15189

ISO 15189 specifies requirements for quality and competence in medical laboratories. ATEK's environmental monitoring solutions help laboratories maintain the controlled conditions essential for accurate diagnostic results and patient safety.

Pharmaceutical

GAMP 5

GAMP 5 provides a risk-based framework for validating computerized systems in pharmaceutical and related industries. ATEK's environmental monitoring platform is designed with GAMP 5 principles, providing the validation documentation needed for GxP environments.

General

ISO 27001

ISO 27001 is the internationally recognized standard for establishing, implementing, maintaining, and continuously improving an information security management system (ISMS). ATEK's integrated platform provides the technical controls, documentation capabilities, and monitoring infrastructure needed to build and maintain a robust, audit-ready information security management system.

General

ISO 30141

ISO 30141 defines the Internet of Things Reference Architecture, including concepts, vocabulary, and architectural models for designing and implementing IoT systems. ATEK's environmental monitoring platform is built on architecture principles that align with ISO 30141, enabling organizations to deploy IoT solutions with proper structure, security, and interoperability.

Laboratory

ISO 20387

ISO 20387 specifies requirements for biobanking, including the collection, preservation, and provision of biological material and associated data. ATEK's monitoring solutions help biobanks maintain the critical temperature control required for biological specimen integrity.

Pharmaceutical

ISO 14644-1:2015

ISO 14644-1:2015 is the international standard for the classification of air cleanliness in cleanrooms and associated controlled environments. It establishes classification levels (ISO Class 1-9) based on airborne particle concentration, defines classification procedures using light scattering airborne particle counters, and specifies sampling and statistical methods for verification. ATEK's environmental monitoring platform provides comprehensive support for continuous compliance with ISO 14644-1, integrating particle counting data, environmental parameters, and automated documentation to maintain cleanroom integrity and regulatory compliance.

General

ISO 9000

ISO 9000 defines fundamental concepts, principles, and vocabulary for quality management systems. Rather than prescribing specific requirements, ISO 9000 provides a foundation for understanding quality management across all organizations, regardless of industry. ATEK's comprehensive monitoring platform embodies these quality principles by providing the data integrity, process visibility, and evidence-based insights necessary for effective quality management.