In conversations with clients, we’re often told that their Building Automation System (BAS) and technical services teams meet the needs of pharmacies and laboratories in terms of monitoring.
Is this really the case?
What Are Clinical Needs?
There are 3 main reasons why a specialized automatic monitoring system like ATEK’s is necessary:
- Loss reduction through an advanced alarm system
- Maintaining regulatory compliance
- Daily operational efficiency
Alarms: Is the BAS Sufficient?
Building automation systems are designed to manage overall infrastructure: HVAC, lighting, access. Their alarm systems are generally connected to the security station, where security agents must manually contact managers.
Common problems:
- Notification delays during security rounds
- No automatic escalation protocol
- Inability to confirm alert receipt
- No multi-channel notifications (SMS, email, call)
A specialized system like ATEK offers custom notification protocols with automatic escalation, receipt confirmation, and remote access to inhibit alarms.
Compliance: Where the BAS Fails
Audit Trail
Building systems can generate files in Excel or CSV format, but it’s the pharmacist or lab manager who must format a report. This formatting allows data adjustment if necessary — which is a BIG NO NO!
When we talk about the “21 CFR Part 11 Electronic Records; Electronic Signatures” standard from the FDA or Health Canada’s Guide 69, to be compliant, the monitoring system must not allow data tampering.
GxP Requirements
According to various GxP standards, data must be:
- Annotated (not deleted)
- Automatically timestamped
- Unalterable once recorded
- Traceable with user identification
The ATEK system ensures compliance through:
- Automatically generated reports
- Advanced note-taking system
- Complete and unalterable audit trail
- Compliant electronic signatures
Building automation systems are not compliant with clinical needs.
Calibration
BAS systems rarely use probes calibrated according to ISO 17025 standards. ATEK provides pre-calibrated certisondes with traceable certificates, and the platform automatically manages annual calibration reminders.
Data Retention
Standards often require data retention of 4 years or more. BAS systems are generally not configured for this long-term retention, and access to historical data can be limited or complex.
Reports
| Aspect | BAS System | ATEK Specialized System |
|---|---|---|
| Report format | Raw CSV/Excel export | Formatted compliant reports |
| Modification possible | Yes (non-compliant) | No (audit trail) |
| Automatic generation | Rare | Standard |
| 21 CFR Part 11 compliance | No | Yes |
Services: What Happens When the System Stops Working?
With a BAS system, maintenance responsibility generally falls to an external property management provider. This provider’s priorities are rarely aligned with the critical needs of the pharmacy or laboratory.
With ATEK:
- Technical support dedicated to life sciences
- Understanding of regulatory issues
- Response times adapted to critical environments
- Continuous training on evolving standards
Summary: BAS vs Specialized System
| Criteria | BAS System | ATEK |
|---|---|---|
| 21 CFR Part 11 Compliance | No | Yes |
| Health Canada Guide 69 Compliance | No | Yes |
| Unalterable audit trail | No | Yes |
| ISO 17025 calibrated probes | Rarely | Standard |
| Advanced alarm protocol | Limited | Complete |
| Automatic compliant reports | No | Yes |
| Specialized life sciences support | No | Yes |
Conclusion
Building automation systems excel in their domain: managing building infrastructure. But they were not designed to meet the strict compliance requirements of hospital pharmacies and laboratories.
A specialized system like ATEK complements the BAS by adding the compliance, traceability, and service layer necessary for regulated environments.
Don’t compromise your compliance — choose the right tool for the right job.
