21 CFR Part 11 Ready

ISA-88 Batch Control

Data Integrity Focus

cGMP Data Systems

SCADA, Historian & Data Acquisition Experts Serving Pharmaceutical & Biotech Manufacturing

Deep expertise in Ignition SCADA, PI System historians, and Canary data platforms applied to pharmaceutical manufacturing. We understand data acquisition, batch tracking, and FDA compliance requirements—delivering validation-ready systems for API production, biologics, sterile fill-finish, and biotech fermentation.

Technology Experts Learning Your Industry

We’re candid: pharmaceutical and biotech manufacturing is new territory for us. But what we bring is deep, proven expertise in the technology platforms your industry depends on—Ignition SCADA, PI System historians, Canary data platforms. We understand data acquisition, batch manufacturing systems, electronic records, audit trails, and validation methodologies. We’re eager to apply our technical capabilities to your compliance-driven manufacturing challenges.

Why Pharmaceutical Manufacturers Consider Streamline

Transferable technical expertise with the platforms your industry trusts

Deep Platform Expertise

14+ years mastering Ignition SCADA, PI System historians, and data acquisition architectures. We’ve deployed these exact platforms across regulated industries requiring audit trails, electronic signatures, and data integrity. Our technical depth transfers directly to pharmaceutical manufacturing requirements.

Data Integrity by Design

Experience building systems where data integrity isn’t optional—pipeline operations under PHMSA scrutiny, food manufacturing with FDA oversight. We design for ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available. Every system architected for regulatory defensibility.

Validation-Ready Systems

We understand what “validation-ready” means: documented architecture, change control, test protocols, traceability matrices. We’ve supported regulated industry installations requiring IQ/OQ/PQ documentation. Our systems are designed to survive audit scrutiny and support your validation lifecycle.

Core Technical Capabilities for Pharma Manufacturing

Proven skills in SCADA, historians, and data systems applied to pharmaceutical operations

Process Data Acquisition

Real-time collection from reactors, fermenters, bioreactors, filtration systems, lyophilizers, autoclaves. Native connectivity to DeltaV, PCS 7, PlantPAx. High-frequency sampling with lossless compression ensuring complete batch genealogy.

Batch Manufacturing Systems

ISA-88 batch control architecture with recipe management, material tracking, and electronic batch records. Equipment arbitration, phase logic, unit procedures. Complete batch genealogy from raw materials through finished product.

FDA 21 CFR Part 11 Architecture

Systems designed for electronic records and signatures compliance. Secure authentication, comprehensive audit trails, data integrity controls, change management. Validated computer system documentation packages supporting regulatory inspections.

Historian & Analytics Platforms

PI System and Canary historian deployment for pharmaceutical operations. Time-series data management, contextualization with PI Asset Framework, advanced analytics. Snowflake OT Data Platform for enterprise-scale multi-site analytics and machine learning.

System Integration Services

Integration with existing pharma infrastructure: DCS systems, MES platforms, LIMS, QMS, ERP. Bidirectional data exchange with TrackWise, Syncade, SAP. OPC-UA, Modbus, proprietary protocols. Unified data architecture across manufacturing sites.

Validation Support Services

Validation lifecycle support including requirements traceability, design documentation, test protocols, validation execution. We provide deliverables supporting IQ/OQ/PQ activities. Change control procedures and deviation management integrated into system design.

Proven Platforms for Pharmaceutical Manufacturing

Deep expertise in the SCADA, historian, and analytics technologies pharmaceutical companies depend on

Ignition by Inductive Automation

Purpose-built for pharma requirements: Native audit trail and electronic signature capabilities. ISA-88 batch control modules. Unlimited tag architecture perfect for multi-product facilities. Vision HMI for validated displays, Perspective for mobile quality operations.

AVEVA PI System

Industry standard historian for pharma: 25+ years PI System experience with Asset Framework organizing by product family, batch campaign, and manufacturing train. Quality data contextualization. Automated deviation investigation support and batch release documentation.

Canary Labs Historian

Cost-effective historian for pharma: Unlimited tag licensing ideal for multi-product facilities and growing biotech operations. Server-based pricing eliminates per-tag costs. Built-in Axiom analytics and validation-ready documentation packages available.

Snowflake OT Data Platform

Enterprise analytics for pharma: Aggregate SCADA, historian, quality, and ERP data across multiple manufacturing sites. Portfolio analytics, quality trending, regulatory reporting automation. Machine learning for process optimization and predictive quality.

FDA 21 CFR Part 11 Compliance Architecture

Systems designed for electronic records and signatures from the ground up

Electronic Records

Complete electronic record generation for batch manufacturing, environmental monitoring, and equipment operations. Records are accurate, complete, contemporaneous, and enduring. Data backup and disaster recovery ensuring record availability throughout retention period.

Audit Trails

Comprehensive audit trail capturing every data change, configuration modification, and user action. Records include: who, what, when, why. Audit trails are computer-generated, timestamped, independently reviewable, and retained throughout record lifecycle. Protected from modification.

User Access Control

Secure user authentication and authorization. Role-based access control limiting system access to authorized individuals. Unique user IDs – no shared accounts. Password complexity enforcement, session timeout, account lockout after failed attempts. Integration with Active Directory/LDAP.

Data Integrity Controls

ALCOA+ principles embedded in architecture: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available. Data checksums preventing unauthorized modification. Change control procedures. Validation supporting data integrity throughout system lifecycle.

ISA-88 Batch Manufacturing Control

Pharmaceutical batch manufacturing demands absolute consistency. ISA-88 batch control architecture with electronic batch records, recipe management, material tracking, and equipment arbitration—delivering repeatable, traceable, compliant batch execution from master formula through finished product release.

Batch Control Capabilities

Master Recipe Management: Centralized recipe database with version control, approval workflows, electronic signatures. Support for multiple product families, formulation variants, scale-up/scale-down recipes. Recipe change control with full traceability.
Control Recipe Execution: Automated batch sequencing following ISA-88 standards. Phase logic, unit procedures, operations, and equipment arbitration. Real-time monitoring against recipe setpoints with automated deviation detection and alarming.
Material Management & Genealogy: Raw material lot allocation, tracking, and genealogy. Automated weighing and dispensing with tolerance checking. Excipient and API tracking. Complete forward/backward traceability supporting investigations and potential recalls.
Electronic Batch Records: Paperless batch records capturing all process data, operator actions, material additions, environmental conditions, equipment status, quality tests. FDA 21 CFR Part 11 compliant with audit trails and electronic signatures at critical steps.
Equipment & Process Integration: Native integration with DeltaV, PCS 7, PlantPAx for automated control. Reactor control, filtration sequencing, CIP/SIP validation, lyophilization cycles. Temperature profiling, pressure management, agitation control.

Batch System Assessment

Evaluate your batch control requirements and recipe management needs

ISA-88 Demo

See recipe-driven batch control with electronic records in action

Process Data Acquisition Systems: Our Core Strength

This is what we excel at. Capturing every critical process parameter from reactors, fermenters, utilities, clean rooms—high-frequency, lossless, contextualized data acquisition supporting batch release, deviation investigations, and process optimization. Real-time collection with historian integration ensuring complete manufacturing intelligence.

Data Acquisition Expertise

Process Equipment Data Collection: Real-time acquisition from bioreactors, fermenters, reactors, crystallizers, filtration systems, centrifuges, dryers, mills, blenders. Temperature, pressure, pH, dissolved oxygen, agitation speed, flow rates. Sub-second sampling with lossless compression.
Environmental Monitoring Systems: Clean room classification monitoring (ISO 5/7/8). Particle counts, temperature, humidity, differential pressure. Incubator and stability chamber monitoring. Cold storage and controlled environment tracking. Automated alert generation on excursions.
Utility Systems Integration: Water systems (WFI, purified water, RO), compressed air quality monitoring, steam quality, HVAC performance, clean steam generation. All critical utilities feeding batch records and supporting investigations.
DCS & PLC Integration: Native connectivity to DeltaV, Siemens PCS 7, Rockwell PlantPAx, ABB 800xA. OPC-UA, Modbus, proprietary protocols. Read process values without impacting control system performance or validation status.
Historian Architecture: High-speed data streams to PI System or Canary historians. Asset Framework contextualization by product family, batch campaign, manufacturing train. Enable long-term trending, statistical analysis, and advanced analytics for process optimization.
Quality System Integration: Automated data transfer to LIMS for trending and specification checking. Integration with QMS platforms (TrackWise, MasterControl) for deviation investigations. SPC charting with real-time limit violations triggering quality workflows.

Data Acquisition Assessment

Evaluate your process data collection needs and historian strategy

Historian Demo

See PI System or Canary historians with pharmaceutical data in action

Snowflake OT Data Platform for Pharmaceutical Enterprise Analytics

Transform pharmaceutical data into enterprise intelligence. Snowflake OT Data Platform aggregates SCADA, historian, quality, and ERP data across multi-site operations—enabling portfolio analytics, quality trending, regulatory reporting, supply chain optimization, and machine learning at scale.

Snowflake Platform Capabilities

Multi-Site Manufacturing Data Integration: Aggregate production, quality, batch, and equipment data from multiple pharmaceutical facilities into unified enterprise platform. Connect Ignition SCADA, PI System/Canary historians, LIMS systems, QMS platforms, and ERP. Standardized data models enabling cross-site analytics.
Quality & Compliance Intelligence: Enterprise-wide quality trending and deviation analysis. Aggregate LIMS results, CCP data, environmental monitoring, deviation records across facilities. Identify systemic quality issues, benchmark site performance, predict quality events. Automated regulatory reporting for FDA submissions.
Production Analytics & KPIs: Real-time executive dashboards tracking batch cycle times, OEE, yield, right-first-time rates across manufacturing network. Compare facility performance, identify best practices, benchmark operations. Portfolio-wide production visibility supporting strategic decisions.
Supply Chain & Material Intelligence: Integrate production data with material inventory, supplier performance, logistics. Raw material traceability across multiple facilities. API and excipient tracking from receipt through finished product. Optimize production scheduling based on material availability and demand forecasts.
Machine Learning & Advanced Analytics: Data science platform enabling predictive models. Equipment failure prediction, yield optimization, quality forecasting. Process parameter optimization using historical batch data. Scale from pilot studies to production deployment serving thousands of users across global operations.
Regulatory Reporting Automation: Automated data aggregation for regulatory submissions. Annual product reviews, process performance reports, stability data trending. Complete audit trail and data lineage supporting regulatory inspections. Validated computer system documentation packages available.

Data Platform Assessment

Evaluate your multi-site data integration and enterprise analytics requirements

Snowflake Demo

See enterprise pharma analytics with multi-facility production data

Pharmaceutical System Integration Expertise

Native connectivity with your existing DCS, MES, LIMS, QMS, and ERP platforms

DCS & Control Systems

Native integration with major distributed control systems. Read process tags via OPC-UA without impacting control loops or validation status. Bidirectional communication supporting recipe downloads and batch control.

MES Platforms

Integration with manufacturing execution systems for recipe management, batch tracking, and material genealogy. Bidirectional data exchange supporting workflow automation and batch release.

LIMS Integration

Automated data transfer to laboratory information management systems. Process data contextualization supporting SPC analysis. Quality test result collection for batch records and trending.

Quality Management Systems

Integration with QMS platforms supporting deviation investigations, CAPA workflows, change control. Automated data collection reducing manual transcription and supporting electronic workflows.

ERP Systems

Enterprise resource planning integration for material tracking, production scheduling, batch release. Manufacturing data visibility enabling supply chain optimization and financial reporting.

Equipment & Instruments

Direct connectivity to analytical instruments, process analyzers, and laboratory equipment. HPLC, GC, spectrophotometers, particle counters, TOC analyzers. Automated result collection eliminating manual entry.

Pharmaceutical Manufacturing Challenges We Can Help Solve

From legacy data systems to compliance gaps—we bring technical solutions to common pharmaceutical manufacturing data challenges

Common Pharma Data Challenges

Technical and compliance issues we hear from pharmaceutical manufacturers seeking modern data systems.

Paper batch records creating investigation delays
Manual data transcription introducing errors
Limited process data visibility during batches
Aging DCS systems with no historian integration
Isolated quality systems requiring manual bridges
Incomplete audit trails creating compliance risk
No centralized data access across facilities
Expensive historian licensing constraining growth

Our Technical Solutions

Proven platform capabilities and integration methodologies addressing pharmaceutical data system needs.

Electronic batch records with embedded e-signatures
Automated data collection eliminating transcription
Real-time process dashboards with trend analysis
Historian integration capturing complete batch data
LIMS and QMS integration with automated workflows
Comprehensive audit trails meeting 21 CFR Part 11
Enterprise historian platforms across facilities
Unlimited tag licensing (Ignition/Canary) enabling scale

Our Honest Approach: New to Pharma, Expert in the Technology

We believe in transparency. Here’s what we bring and how we’ll approach working with pharmaceutical manufacturers.

What We Bring to Pharma

Deep technical expertise in the exact platforms your industry uses: Ignition SCADA, PI System historians, Canary data platforms. 14+ years building data acquisition systems, batch control, and compliance-ready architectures for regulated industries. We understand validation, audit trails, electronic signatures, change control. We know how to build systems that survive regulatory scrutiny.

How We'll Learn Your Industry

We’re committed to understanding pharmaceutical manufacturing deeply—not just the technology, but your processes, your compliance challenges, your quality systems. We’ll invest time learning cGMP requirements, understanding your batch manufacturing workflows, studying your quality documentation. We’ll partner with your subject matter experts, leverage your process knowledge, and apply our technical capabilities to your specific needs.

Why This Approach Works

Pharmaceutical manufacturing needs technology experts who can apply proven platform capabilities to your specific requirements. You have the process expertise, quality knowledge, and regulatory understanding. We bring the technical depth in SCADA, historians, and data systems. Together, we can build validation-ready systems that meet your compliance needs while leveraging modern platform capabilities. Our honesty about being new to pharma means we’ll listen carefully, ask the right questions, and deliver systems designed to your actual requirements—not assumptions.

Ready to Discuss Your Pharmaceutical Data Systems?

Let’s explore how our SCADA, historian, and data acquisition expertise can support your pharmaceutical manufacturing operations