September 12, 2025

Overview
A growing Canadian pharmaceutical manufacturer approached Grantek regarding a plant expansion project that required a new historian system. The manufacturer faced six-figure licensing costs and vendor lock-in for historian systems while expanding their production facility. This historian enables the collection, visualization, and reporting of time-series and event-based data (such as sensor trends and alarm events). The manufacturer worked with Grantek to identify constraints with their current system including: regulatory compliance (21 CFR Part 11, including data integrity, GxP, GAMP 5), reliability and performance, cost-effectiveness, usability, interoperability with SCADA (~20 equipment units, ~500 I/O devices, ~5,000 points) and scalability (up to 100,000 points). Licensing cost was a high-priority constraint due to previous experience. Some solutions include per-tag pricing, which can lead to significant budgetary impact when considering 5,000 to 100,000 tags for historization.

Challenges
Grantek and the manufacturer began this project with a kick-off meeting to begin the planning phase for the site expansion. After completing a preliminary engineer study, Grantek worked closely with the client to identify several key challenges:

Cost
Cost (historian, SCADA, operating system, data storage) was a key constraint. Commercial historian solutions on the market can require upfront and recurring licensing costs, both in the six figures. The solution currently used on-site (in the existing facility, not the expansion) also raised cost concerns. The targeted solution needed to have minimal to moderate cost impact (CAPEX/OPEX) on the project.

Regulatory Compliance
Data integrity and management of electronic records (per FDA 21 CFR Part 11 and Health Canada regulations) are key requirements in the pharmaceutical industry. Further analysis was required, and functional specifications needed updates accordingly. This includes, but is not limited to:
• Data accuracy
• Data security (access and protection)
• Data retention (up to 15 years for some clients)
• Audit trail
• Backup and disaster recovery

Reliability, Performance, and Scalability
• Reliability: An automated manufacturing site requires de facto reliability. Due to the importance of trend recording that’s leveraged in batch records and investigations, there’s significant risk to clients if the historization is not reliable. Reliability of data acquisition, processing, transportation, storage, and visualization must be thoroughly analyzed. Typical methods include sampling requirements/deadbands, scaling, data acquisition alarms, buffering, interpolation vs. raw data management, and precision considerations.
• Performance: Efficient data recording and visualization/reporting accelerate decision-making processes. At a sampling rate of 1 second over 4 weeks, this represents ~2.5M samples. Visual representation of such data volumes in trend viewers or reports requires upfront consideration. Disk space can become a cost/logistical concern when acquiring tags at high sampling rates; compression and data storage designs should be evaluated. The same considerations apply to data storage technology selection (file vs. database).
• Scalability: A manufacturing site evolves continuously as a living system. Addition of tags, users, reports/views, and the ability to access previously acquired information (for data analysis, cross-comparison, etc.) are critical to site operations. This requires careful analysis of additional processing units needed for data capture, buffering sizes, and storage capacity (including tiered storage and archiving).

Industry Standards, Interoperability, and Ease of Maintenance
• Communication Protocol Support: Since the historian system serves as a connection hub to internal PLCs and equipment devices with various communication protocols and specific data requirements, supporting a wide range of input communication protocols is essential (OPC UA, Ethernet/IP, Siemens drivers, etc.). Similarly, output to SQL and interoperability with other systems (MES, UNS, corporate historian) is critical for organizations.
• Industry Standards: Using established and current technologies provides significant benefits without being an early adopter. It’s important for clients to use known, up-to-date technologies without breaking new ground. Commercial licensing commonly brings either security with high costs, risk of technology obsolescence, or vendor lock-in. Conversely, open source requires careful consideration due to potential lack of support or instability risks.

Solutions
Grantek leveraged its experience in SCADA and historization to select and configure a solution that to overcome those challenges. The production solution centers on Ignition from Inductive Automation, utilizing a scaled-out architecture with Perspective’s HTML5, server-based platform. This robust foundation incorporates redundant I/O tag gateways for seamless tag acquisition, connecting to devices primarily through OPC UA protocols, while redundant front-end gateways handle visualization and reporting functions with high availability.

The database infrastructure leverages PostgreSQL database servers combined with TimescaleDB for advanced time-series management. This powerful combination delivers significant performance gains compared to commercial alternatives, providing superior data space efficiency, processing speed, and compression capabilities. Pgpool serves as intelligent middleware between PostgreSQL servers, ensuring optimal performance and reliability. The entire system operates on a Linux operating system (Ubuntu) within a virtualized environment, eliminating licensing costs while maintaining enterprise-grade performance.

Grantek delivered a complete documentation package specifically designed to address the client’s User Requirements Specification (URS). The Functional Specification provided detailed requirements including precise visualization and performance specifications, such as interpolation protocols for long time span visualization while maintaining raw data integrity for reporting purposes. The Design Specification outlined critical optimizations including sampling rates, sampling groups, dead bands, clamping protocols, and implementation of a Unified Namespace (UNS) to standardize tag paths and identifiers across the system.

Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) documentation included reusable templates and leveraged proven methodologies, complemented by comprehensive user manuals and training materials. All documentation was designed to meet multiple regulatory standards including 21 CFR Part 11, GAMP 5, and ISA 101, featuring verifiable and testable specifications with complete traceability documentation.

The solution included comprehensive user training programs alongside detailed design guidance for future system scaling. This covered strategic approaches for tag additions, gateway expansion, and tiered storage implementation, ensuring the client’s team could confidently manage and grow the system independently while maintaining optimal performance standards.

The semi-open-source historian architecture delivered substantial financial advantages and operational freedom. By eliminating vendor lock-in, the solution provides full scalability to accommodate over 100,000 tags without additional licensing constraints. The strategic use of open-source technologies including Linux, PostgreSQL, TimescaleDB, and pgpool enabled the client to avoid significant six-figure one-time and recurring licensing costs while eliminating restrictive vendor dependencies. Unlike traditional historian vendors that impose per-tag pricing models, this solution ensures cost predictability regardless of future tag quantity increases. The entire implementation was completed within six months, with Factory Acceptance Testing executed in Grantek’s development environment, followed by successful deployment and Site Acceptance Testing in the client’s production environment.

The combined solution successfully integrates proven open-source backend technologies with Inductive Automation Ignition’s cost-effective, high-performance frontend, creating a platform that exceeds client requirements while delivering exceptional reliability, scalability, and maintainability. Beyond historian capabilities, Ignition Perspective provides a robust and scalable SCADA platform foundation. The implementation positions the client for long-term success through comprehensive staff training, enabling rapid expansion and integration of advanced data processing capabilities built upon the Unified Namespace architecture and standard SQL integrations for data warehouse, ETL, and post-processing analysis applications. Grantek’s comprehensive documentation package significantly reduced the client’s Computer System Validation (CSV) efforts by aligning with their Quality Management System requirements. The Installation/Operational Qualification (IOQ) package directly referenced SAT tests executed by Grantek, providing verifiable compliance with multiple regulatory frameworks and substantially reducing validation timelines and costs.

The manufacturer was able to realize $100,000+ annual savings at first, no price per tag, zero vendor lock-in with full scalability to 100,000+ tags and FDA 21 CFR Part 11 compliant with faster validation. This solution was deployed by Grantek in under 6 months, when compared to the typical 12+ months for traditional solutions.