Webinar Description
Alarm management systems detect and prioritize alarms, but in a GMP environment, the response is only half the work. Regulators and QA teams also want to know why an event happened, who resolved it and whether it affected the product. Those answers often sit in paper logbooks, spreadsheets and email threads, rebuilt days later when an inspector asks.In this webinar, Kate McClintock, Shwetha Anand and Frank Dzuno of Datacor show how SignalHub captures alarms, user interventions, alerts and audit trail events from existing shop floor systems and guides teams to a complete, signed record. They walk through three use cases from regulated manufacturers, then take audience questions.
What You'll Learn
- How shift-based alarm review becomes a guided task with role-based sign-offs and Part 11 compliant electronic signatures
- How EMS alarms on critical utilities such as HVAC, water for injection and freezers are paired, annotated and packaged with reports for batch release
- How each user intervention, such as a batch hold or a mid-run formula change, ends with a documented justification and deviation assessment
Speaker Information
Kate McClintock leads the sales team at Datacor for the GMP Data Hub product line. She has spent about 17 years with the Informetric team, now Datacor, supporting life science accounts and the partner channel.
Shwetha Anand is Product Manager at Datacor, where she owns the life sciences product suite. Her focus is data contextualization for GMP manufacturing, working across software systems with the quality and automation teams who rely on them.
Frank Dzuno is Director of Software Engineering at Datacor, leading product development, quality, support and solution delivery. He joined Informetric in 2000 and has worked on the strategy, design, development and delivery of Informetric products, including SignalHub.
About SignalHub
SignalHub turns GMP critical events into complete, signed records. It reads alarms, user interventions, alerts and audit trail events from your existing DCS, MES and process historians, groups related events by shift, batch or root cause, and guides operators, supervisors and QA through a workflow that mirrors your SOPs. Each review ends in a secure record ready for inspection or transfer to your document management system. SignalHub is designed to support 21 CFR Part 11, EU Annex 11 and ALCOA+ data integrity principles.
See It on Your Own Events
Talk with a Datacor expert about how SignalHub would handle the alarms, interventions and audit trail events at your site.
Frequently Asked Questions
Which systems can SignalHub collect events from?
SignalHub collects events from Emerson DeltaV, including the Batch Historian, Event Chronicle and DeltaV MES, and from AVEVA PI through PI OLEDB and PI Event Frames. It also reads from relational databases and can detect events from files sent to it. One deployment can monitor several DCS databases at once.
How does SignalHub make sure no alarms are missed?
SignalHub tracks the last point it collected from each source and resumes from that point after any interruption, with retry logic built in. A configurable heartbeat warns users in the application when a source stops responding, so a quiet shift means no alarms occurred, not that data stopped arriving. Collection frequency is configurable, from a few times a day for shift review to every 20 or 30 seconds for near real-time response.
Can different types of alarms follow different workflows?
Yes. You can configure as many workflows as your site needs, such as one for EMS alarms and another for production alarms. SignalHub can assign a workflow automatically based on event type, or let the user choose one. Each workflow can require as many reviewers and signatures as your SOP calls for.
Can events be grouped by batch instead of by shift?
Yes. Records can be grouped by batch, shift, campaign, product or event type, or by a combination of an identifier and a time window. Sites that don't follow shift-based review can configure SignalHub so reviewers start work on an event as soon as it comes in.
What happens if someone enters incorrect data and signs off?
Signed entries are never overwritten. A correction creates a new signed entry, prepopulated with the previous values, and the original stays in the record's history. SignalHub displays the latest values, and the final report can show the full history of entries in an appendix. Your workflow decides whether a closed record can be reopened, and by which role.
Can SignalHub capture events that happened before go-live?
Yes. A start date in the collection configuration can be set back in time to capture earlier events, such as the last three months of alarms. Administrators can also reprocess data for a defined time range.
