Multi-regulation compliance from a single platform

ISO 14644, EN 16798, ICPE, GMP Annex 1, ARS — pre-configured templates, automated monitoring, audit-ready reports. Zero non-conformities across deployed sites.

Regulatory compliance

A hospital, a factory, an industrial site — dozens of standards to meet simultaneously

Every zone on your site is subject to different regulations, each with its own parameters, thresholds, sampling frequencies and reporting formats. Quality teams juggle between spreadsheets, log books and separate filing systems. TERA 360 centralizes all your regulatory obligations into a single platform, with pre-configured templates maintained and updated by our specialists.

ISO 14644

Cleanrooms & operating rooms

GMP Annex 1

Sterile pharmaceutical manufacturing

EN 16798

Commercial buildings & offices

ICPE / IED

Industrial sites & emissions

ARS

Aquatic centers & swimming pools

The challenge

Overlapping regulations, unsustainable compliance

A typical hospital manages ISO 14644 for operating rooms, EN 16798 for occupied spaces, ICPE requirements for technical installations, and potentially ARS mandates for pool facilities. A pharmaceutical site adds EU GMP Annex 1 and 21 CFR Part 11. Each regulation has its own parameters, thresholds, sampling frequencies, reporting formats and audit expectations.

Manual tracking is unsustainable

Quality and compliance teams maintain separate spreadsheets, log books, and filing systems for each regulation. Data is collected manually, transcribed, calculated, and compiled into reports. The process is slow, error-prone, and consumes skilled personnel who should be analyzing data, not collecting it.

Audit risk is ever-present

Regulators expect complete, timestamped, tamper-proof records. Data gaps, missing signatures, late reports, and inconsistent formats create audit findings. Each finding triggers corrective actions, follow-up audits, and management attention. In regulated industries, non-conformities can halt production or operations.

Regulations evolve constantly

EU GMP Annex 1 was revised in 2023. ISO 14644-3 updated its monitoring guidance. EN 16798 replaced EN 15251. ICPE requirements are amended by prefectoral decree. Keeping compliance templates current requires regulatory expertise that most facility teams lack.

How TERA 360 works

Pre-built regulatory intelligence, automated execution

TERA 360 embeds regulatory knowledge into the platform — parameters, thresholds, sampling requirements, and report formats are pre-configured for each applicable regulation.

Regulatory templates

Select the regulations applicable to each zone or environment. TERA 360 automatically configures the required parameters, sampling frequencies, alert thresholds (action limits and specification limits), and report formats. Templates are maintained and updated by TERA's regulatory specialists as standards evolve.

Continuous monitoring

All regulated parameters are monitored continuously at the frequencies specified by each applicable standard. Data is stored with timestamps, sensor calibration references, and data integrity controls. No gaps. No manual intervention. No transcription errors.

Automated reporting

Compliance reports generated automatically per regulation, per zone, per period. Each report follows the format expected by the relevant authority or auditor. Excursion events documented with root cause, corrective action and effectiveness verification. The complete audit trail is always available.

Regulations covered

Built-in templates for major standards

ISO 14644

Cleanroom and controlled environment classification. Continuous particle monitoring per ISO 14644-3. Automated classification calculations for ISO 14644-1 classes 1-9. Sampling point plans, at-rest and in-operation states.

Cleanrooms Operating Rooms

EU GMP Annex 1

Manufacture of sterile medicinal products. Continuous environmental monitoring requirements including particles, DeltaP, temperature, humidity. Grade A-D zone monitoring. Excursion management and CAPA workflows.

Pharmaceutical

21 CFR Part 11

Electronic records and electronic signatures. Audit trails, role-based access, electronic signatures, data integrity validation, tamper detection. Required for pharmaceutical and FDA-regulated facilities.

Data Integrity

EN 16798

Indoor environmental input parameters for design and assessment. IAQ categories (I-IV), thermal comfort criteria, ventilation requirements. Compliance tracking for commercial buildings, offices, educational facilities.

Commercial Buildings

ARS / Health Code

Agence Regionale de Sante requirements for swimming pool air quality. Trichloramine monitoring, water quality parameters, ventilation adequacy. Continuous compliance tracking with regulatory reporting.

Aquatic Facilities

ICPE / IED

Installations Classees pour la Protection de l'Environnement and Industrial Emissions Directive. Emission monitoring, environmental impact tracking, regulatory threshold management. Automated GEREP/BDREP reporting support.

Industrial Sites

Dashboards & alerts

Compliance visibility for QA and management

TERA 360 multi-regulation compliance dashboard

All your reporting, audit-ready

Multi-regulation dashboard — All applicable regulations on a single screen. Per-zone compliance status, current excursions, upcoming report deadlines, and trend indicators. Color-coded by regulation — ISO 14644 green does not mean EN 16798 is also green.
Excursion management center — Centralized view of all excursions across all regulations. Each event linked to the specific regulatory threshold breached, with automatic classification (action limit vs. specification limit). Investigation workflows with root cause categories, corrective action tracking, and effectiveness verification.
Audit preparation toolkit — One-click generation of audit packages per regulation. Includes compliance summary, excursion history, corrective action log, calibration records, and system validation documentation.
Regulatory calendar — Upcoming reporting deadlines, calibration due dates, re-qualification schedules, and regulatory review milestones. Automated reminders and integration with team calendars.

Benefits

From compliance burden to operational advantage

Non-conformities across all deployed sites. Continuous monitoring eliminates data gaps. Automated reporting eliminates human error. Audit preparation is measured in hours, not weeks.

100 %

Audit readiness. Every piece of compliance data is available, timestamped, and integrity-protected at all times. An unannounced audit triggers a report generation, not a scramble.

-85 %

Reduction in manual work. Automated data collection, classification calculations, report generation and excursion documentation eliminate the bulk of manual compliance work.

QA personnel freed for what matters

QA personnel are redirected to root cause analysis, process improvement and regulatory strategy — high-value tasks instead of data collection and transcription.

Multi-regulation coverage

One platform, one data pipeline, one team. Sensors deployed for ISO 14644 also serve GMP Annex 1 requirements. Energy data collected for EN 16798 feeds into ISO 50001 reporting. No duplication, no inconsistencies between systems.

Audit packages are complete and organized by regulation

Auditors receive a complete, organized package — not a box of printouts.

Key metrics

Measured results from deployed sites

Non-conformities

100%

Audit readiness

85%

Less manual work

Regulations covered

Ready to simplify your compliance?

We'll map your regulatory landscape, configure the applicable templates, and build your audit-ready monitoring architecture.

Discuss your project