Monitoring systems must modernize to keep up with Life Sciences’ demands

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Today’s industries are increasingly competitive and regulated. Life science companies stake their reputations on their ability to provide regulators with data-intensive, assured, high-credibility reporting. (For example, regulators like the Food & Drug Administration (FDA), and reports demonstrating compliance with the 21CFR Part 11 section of the standard.) Traceability of critical environmental variables like temperature, pressure, humidity, and organic and non-organic contaminates help validate the integrity and safety of life science manufacturing processes. This is the case from the raw materials phase to the finished and packaged goods phases. When firms submit incomplete or flawed environmental monitoring system data to the regulators, they face the prospect of extensive product and delivery delays or fines.

Facility managers, quality and compliance managers, and others must maintain the safety and quality of production operations. They require updated control technologies to manage new levels of regulation-driven complexity. Such technological solutions should be designed to enable facilities and quality control staff to address the following challenges:

Environmental control and monitoring systems

• Operators must be able to control environmental conditions tightly in their manufacturing space, including temperature, cleanliness, and humidity. Computerized monitoring systems must also record and report on events occurring within the manufacturing space to document and prove compliance.
  
  Such computerized systems should gather data from the devices in the space and immediately transfer that to a data management platform with zero latency (like AVEVA PI). This way, stakeholders have a mechanism for quickly and easily collecting, enriching, storing, and accessing reliable, real-time operations data.

Cybersecurity

• According to Statista, in 2022, manufacturing experienced the highest share of cyberattacks among the leading industries worldwide. Therefore, life sciences quality control personnel must work with facility management systems to enable robust cyberattack protection. Some solutions in the marketplace, like the Schneider Electric EcoStruxure Building Operation platform, undergo a Secure Development Lifecycle (SDL) development process before release, which lowers the risk of a successful cyberattack.
  
  This secure-by-design approach enables systems managers to ‘allowlist’ compliance information access to specific IP addresses, restricting access levels outside those IP addresses. In addition, configurable password policies provide secure access to the system. And the use of biometric technology for two-stage authentication strengthens cybersecurity. 

Performance reporting

• Regulators require high data integrity reporting that contextualizes information with electronic records and signatures. The environmental monitoring and compliance system (EMS) must proactively display environmental report information in the secure formats desired by regulators.
  
  These reports present evidence that the product manufacturing process aligns with mandated license-to-operate conditions. The EMS’s ability to templatize and simplify the presentation of the data can ensure compliance while delivering the time-to-market required by the life sciences companies. Once defined, the reports should automatically be triggered to highlight alarm status and conditions.

Environmental monitoring system modernization benefits

New generation solutions such as the EcoStruxure Building Operation Compliance Pack from Schneider Electric address these challenges and provide flexibility layers that simplify life sciences compliance-related processes. Technology innovations such as time-scale historical data access (2,000 times faster than standard database queries), dedicated onboard native data storage with auto backfill in case of network failures, and enterprise-wide visualization of data across multiple geographical locations all contribute to compliance process simplification.

Below are several examples:

Reports on alarm conditions

• Unlike a standard alarm indicating “low temperature” or “high temperature,” advanced systems such as Compliance Pack identify and describe the event that led to the alarm. For instance, the alarm generates a report that includes critical historical data (like a -40⁰C freezer degrading over time, indicating a hardware or external condition issue, or evidence of a sudden temperature rise indicating a door has been left open). Such auto-generated details give facility and quality control managers more time to react to a possible problem, thereby avoiding creating volumes of extra paperwork to describe an incident deviation to regulators.

Expedited decisions

• Quality managers can now quickly ascertain the duration of a particular deviation. This allows them to make better decisions. For instance, a deviation of one minute may not result in any degradation in quality. However, a five-minute failure might affect temperature or humidity and induce spoilage. Based on this data, users can quickly determine whether a product is designated as waste. These decisions are automatically documented and distributed to the right person at the right time.

Single pane of glass access

• Life sciences firms that use the EcoStruxure Building Operation platform enjoy the simplicity of accessing their Building Management System (BMS) and Environmental Monitoring System (EMS) from a single screen or device. One client based in the US enjoys the convenience of having one team of engineers work on both systems. They only need one set of hardware to execute tasks. As a result, they save time and money during training and ongoing operations while boosting overall data integrity.

Preserving existing investments while modernizing compliance approaches

The design of solutions such as Compliance Pack helps protect the life science client investment. Those who upgrade can maintain their existing hardware, avoiding a costly total “rip and replace” scenario. Compliance Pack is a modern, open IP-based offering. It enables site expansion without additional investment other than the investment to connect any additional required field devices.

Watch the Schneider Electric EcoStruxure Building Compliance Pack’s one-minute video or access our informational brochure to learn more.