Lighthouse Worldwide Solutions releases technical paper on the best approach to GMP validated data for aseptic manufacturing
Cleanroom operator connecting to EMS monitoring particle counts inside an isolator
An Environmental Monitoring System (EMS) is very different from a Building Management System (BMS)
A BMS, also referred to as a Building Automation System (BAS), is a computer-based control system installed in facilities to control and monitor the site's mechanical and electrical equipment such as heating, cooling, ventilation, lighting, power, fire, and security systems.
In industries like aseptic manufacturing of pharmaceutical medicinal products, facilities require Control (BMS) and Monitoring (EMS) solutions.
Since critical steps are mandated for Good Manufacturing Practices (GMP) based on validation and regulatory compliance, an EMS is authenticated based on validating that the system design meets the system’s functionality, which should be outlined in a User Requirement Specification (URS) document.
A URS is typically developed following a formal risk analysis study of the facility, the processes, and the product's critical locations.
All EMS data must be GMP compliant: data records with timestamps and alarm details are used to provide evidence that a product batch has been manufactured in ideal environmental conditions and product quality, safety, and efficacy remained intact before market release.
Difference matter: Knowing BMS and EMS Systems is a technical paper released by Lighthouse Worldwide Solutions. Download the full document now.
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