Compliance frameworks

Built for the specific framework your inspector enforces.

Generic environmental monitoring tools produce charts. Inspectors don’t want charts — they want records that map to specific regulatory sections, intervals, thresholds, and corrective-action chains. The frameworks below are supported natively. Each maps to one or more verticals; each generates inspector-ready documentation in the format and language the regulator uses.

Group A

Pharmacy & Healthcare

Pharmaceutical preparation and clinical care environments — where excursions affect patient safety and accreditation depends on documentation.

USP <797>

Pharmaceutical Compounding — Sterile Preparations

USP · official Nov 1, 2023 · enforced by State Boards of Pharmacy, FDA, Joint Commission

The revised chapter requires continuous documented monitoring of differential pressure, temperature, and humidity in classified compounding areas. Records must be retrievable on inspector demand. Manual logs no longer satisfy. RH must remain < 60% at all times.

temperature continuous
humidity < 60%
Δ pressure cleanroom
particle ISO 5/7/8
Supported Verticals: Compounding
USP <800>

Hazardous Drugs — Handling in Healthcare Settings

USP · enforced by State Boards of Pharmacy, OSHA, NIOSH

Containment-related environmental controls for hazardous drug handling. Negative-pressure containment areas, documented airflow, and integrated personnel sampling. Frequently audited alongside USP <797>.

negative pressure
12 ACH minimum
temp / humidity
containment integrity
Supported Verticals: Compounding
ASHRAE 170

Ventilation of Health Care Facilities

ASHRAE · referenced in CMS / Joint Commission / state DOH

Design standard adopted operationally for healthcare facility ventilation, pressure relationships, and air change rates. Operating rooms (positive pressure), soiled utility (negative pressure), specific air change minimums per space type.

pressure relationships
air change rates
temp / humidity
space-type schemas
Supported Verticals: Outpatient
CDC VFC

Vaccines for Children Program

CDC · administered by State Health Department coordinators

Federal requirements for vaccine cold-chain documentation: certified continuous DDLs (primary + backup), twice-daily logging, calibration certificates, formal excursion reporting, and corrective-action documentation. ~37,000 enrolled providers nationally.

refrig 36–46°F
freezer ≤ 5°F
DDL primary + backup
calibration cert
Supported Verticals: Vaccine
AAMI ST108

Water Quality for Sterilization Equipment

AAMI · enforced by Joint Commission, CMS, state DOH

Our heritage. Water quality requirements for medical device sterilization including conductivity, pH, hardness, endotoxin. The compliance pattern from which our environmental monitoring schemas were extended. Continues in production for hospital and lab customers.

conductivity / TDS
pH / hardness
endotoxin
microbial
Supported via Caseore platform
RD62 / 13959

Dialysate Water Quality

AAMI / ANSI / ISO · enforced by Joint Commission, CMS for dialysis providers

Water quality for hemodialysis applications including bacterial endotoxin, chemical contaminants, and microbiological purity. Already in production for dialysis customers.

bacterial counts
endotoxin
chemical purity
testing intervals
Supported via Caseore platform
Group B

Cannabis

State-by-state regulatory landscape with consistent underlying patterns: documented continuous environmental control across the cultivation and processing cycle.

State Cannabis

State Cannabis Control Board Regulations

CO MED · CA DCC · MA CCC · MI CRA · NY OCM · NJ CRC · IL IDFPR · OR OLCC · WA WSLCB · others

Each legal state operates an independent regulatory framework, but all share the core requirement that cultivators demonstrate environmental control was maintained throughout cultivation cycles. State-specific reporting templates supported as new markets are added.

stage-specific RH/T
CO2 for safety
VPD & airflow
batch-level records
Supported Verticals: Cannabis
ASTM D8

ASTM Cannabis Committee Standards

ASTM International · adopted by reference in some state cannabis regulations

Industry-developed standards for cannabis cultivation, processing, and storage including water activity targets (0.55–0.65 typical), environmental control during drying and curing, and laboratory testing methodology. Increasingly referenced in state regulatory frameworks.

water activity 0.55–0.65
drying RH protocols
curing protocols
storage RH
Supported Verticals: Cannabis
Group C

Food & FDA-Regulated Manufacturing

Continuous documented control of temperature and environmental conditions at points where biological hazards multiply.

FSMA / 117

Food Safety Modernization Act — Preventive Controls

FDA · 21 CFR Part 117 · risk-based preventive controls for food facilities

Continuous environmental monitoring as part of preventive controls for biological hazards. FDA issued 149 warning letters to human food facilities (2017–2023) citing GMP and preventive control violations. Listeria environmental monitoring is humidity-correlated.

CCP temperature
cold ≤ 41°F
hot ≥ 135°F
Listeria EM
Q2 build Verticals: Food
HACCP

Hazard Analysis & Critical Control Points

FDA · USDA · adopted by reference in state retail food codes

Systematic temperature monitoring at Critical Control Points. FDA requires HACCP for seafood, juice, dietary supplements; USDA for meat & poultry. Many state and local codes require HACCP for retail food establishments performing specialized processes.

CCP identification
critical limits
monitoring frequency
corrective action
Q2 build Verticals: Food
MoCRA

Modernization of Cosmetics Regulation Act

FDA · phased implementation 2025–2026 · increased post-MoCRA recordkeeping

Significant expansion in compliance burden for cosmetics manufacturers. FDA inspection authority is increasingly active. Manufacturing environment temperature, humidity, product stability, and adverse event documentation all in scope.

manufacturing T/RH
stability
adverse events
facility records
Q2 build Verticals: Cosmetics
Group D

Laboratory & Cleanroom

Particulate, pressure, temperature and humidity classifications for controlled environments.

ISO 14644

Cleanrooms — Classification of Air Cleanliness

ISO · referenced in FDA cGMP, USP <797>, semiconductor and life sciences

Particle count classifications (ISO 5 / 7 / 8) for cleanrooms across pharmaceutical manufacturing, USP <797> compounding, IVF labs, and semiconductor fab. Pressure relationships and air change rates per classification level.

particle counts
classification
pressure cascade
air changes
Supported Verticals: Labs · Compounding
CLIA / CAP

Clinical Laboratory Improvement & Pathologist Accreditation

CLIA · CAP · enforced via federal certification & voluntary accreditation

Environmental control documentation for clinical laboratories — sample storage temperatures, equipment calibration, controlled environment monitoring. CAP-accredited labs already use compliance management software for proficiency testing and equipment calibration.

sample storage T
equipment cal
document control
competency records
Supported Verticals: Labs
21 CFR 1271

Human Cells, Tissues & Cellular Products (HCT/P)

FDA · IVF labs, tissue banks, cell & gene therapy facilities

Environmental and storage requirements for human cellular products. LN2 tank monitoring, incubator environmental control (T, RH, CO2, O2), VOC sensitivity, and cleanroom-classified workflow.

LN2 level / temp
incubator T/RH/CO2
VOC
chain of custody
Q2 build Verticals: IVF
Group E

Long-term care, Animal & Other

Adjacent regulatory frameworks supported via the same audit-trail engine.

CMS QSO-17-30

Long-Term Care Legionella & Environmental

CMS · enforced via Conditions of Participation surveys

Water management programs for healthcare facilities including long-term care, with linked environmental monitoring expectations. Already in production for LTC customers; environmental monitoring is the natural adjacent module.

water mgmt program
resident T 71–81°F
infection ctrl docs
isolation rooms
Supported Verticals: LTC
AAHA

American Animal Hospital Association Accreditation

AAHA · voluntary accreditation but valued in veterinary practice

Includes facility environmental documentation for surgical and treatment areas. Operationally similar to outpatient surgical compliance; veterinary surgical practices share the small-footprint, owner-operator profile.

surgical T/RH
facility records
pharmacy / med storage
infection ctrl
Q2 build Verticals: Veterinary
USDA / AAALAC

Animal Welfare & Research Facility Accreditation

USDA Animal Welfare Act · AAALAC voluntary accreditation

Stringent environmental documentation for animal research facilities — university vivariums, contract research organizations, and other animal-research operations. Maps cleanly to existing audit-trail patterns.

animal T/RH ranges
light cycles
ventilation
documented review
Q2 build Verticals: Veterinary
ASHRAE TC 9.9

Thermal Guidelines for Data Processing Environments

ASHRAE · operationally referenced in colocation SLAs & SOC 2 environmental controls

Inlet air 65–80°F recommended (59–104°F allowable by class), 40–60% RH recommended. Multiple monitoring points per rack and sensor accuracy ±3% RH can support compliance verification for colocation, edge computing, and regional MSP environments.

inlet T per class
RH 40–60%
rack-level mon
SLA reports
Evaluating Additional framework
AAM / ASHRAE 24

Cultural Institutions & Archives

American Alliance of Museums accreditation · ASHRAE Handbook Chapter 24

Continuous T & RH logging for collection storage and gallery spaces, microclimate documentation for sensitive materials, UV and pest management. Sensor and monitoring workflows can support preservation records for conservation teams.

T & RH continuous
microclimate
UV monitoring
loan-condition docs
Evaluating Additional framework
Why this matters

Schemas, not generic dashboards.

A USP <797> differential-pressure log is structurally different from an FSMA cold-holding record, which is different from a cannabis cultivation environmental log. Inspectors expect their framework’s language, intervals, and excursion definitions. Generic charts force you to translate; native schemas don’t.

i

Framework-specific intervals

USP <797> environmental sampling is monthly minimum for Cat. 2 CSPs. CDC VFC requires twice-daily logging. Cannabis state cycles are batch-tracked. Each schema enforces the cadence its framework expects.

ii

Excursion definitions per framework

What counts as an excursion differs by regulation. RH > 60% for > 1 hour vs. RH transient excursions for compounding; specific deviation thresholds for VFC. Native schemas encode these definitions.

iii

Inspector-ready report templates

The format the inspector looks for varies. State Board of Pharmacy reviewers, CDC VFC site visits, cannabis state inspections, FDA FSMA audits — each framework gets its native report template, generated on demand.

iv

Multi-framework consolidation

A hospital system runs USP <797>, RD62 dialysate, ASHRAE 170, AAMI ST108. A multi-state cannabis operator runs different state regulations across jurisdictions. One audit surface, multiple frameworks, no per-framework vendor sprawl.

Discuss your framework

Don’t see your regulation?

If your industry operates under a documented compliance framework not listed above, the underlying audit-trail engine likely supports the pattern. The work is in the framework-specific reporting templates and excursion schemas.

Discuss with us → Industries page