Built for validated, audit-ready production.
Pharmaceutical & Life Sciences Manufacturing
Validated Automation Where Compliance Is Not Optional
In pharmaceutical and life sciences manufacturing, the stakes are too high for automation that is almost compliant. Regulatory gaps, failed validation, or data integrity issues can halt production, trigger warning letters, or put patients at risk. Lineside designs control systems built for GMP environments from the start, with the traceability, containment, and validation documentation that FDA, Health Canada, and your own quality team require.
We bring engineering rigour from high-demand sectors and apply it to the precision and compliance demands of pharmaceutical manufacturing. Whether you’re a CDMO managing high-mix production or a manufacturer scaling a new product line, Lineside delivers automation you can validate, audit, and rely on.
Compliance starts with engineering, not paperwork. Let’s talk about your facility.
REGULATORY FRAMEWORK
Automation Aligned with Pharma Regulatory Requirements
Pharmaceutical manufacturing operates under some of the most stringent regulatory oversight in any industry. Every control system Lineside designs is developed with awareness of these requirements because the architecture decisions made at the design stage determine your compliance posture for the life of the system. We implement systems that fit your SOPs.
Built for FDA, Health Canada, and ISPE Frameworks
21 CFR Part 11
FDA electronic records & signatures: audit trails, access control, data integrity.
GMP
Good Manufacturing Practice: consistency, documentation, contamination prevention.
GAMP 5
ISPE risk-based approach to computer system validation.
Health Canada
Canadian pharma manufacturing regulations & drug GMP guidelines.
IQ / OQ / PQ
Installation, Operational, Performance Qualification: full validation lifecycle.
21 CFR Part 210/211
Current Good Manufacturing Practice regulations for finished pharmaceutical products.
Lineside’s engineering approach incorporates your requirements at the specification and design stage so your validation effort is supported by clean, well-documented code, comprehensive I/O documentation, and systems that behave predictably under test conditions.
WHAT WE HEAR FROM PHARMA & LIFE SCIENCES CLIENTS
The Challenges You're Facing
Pharma and CDMO clients we work with consistently raise these pain points.
21 CFR Part 11 Gaps
Electronic records and signatures that don't meet 21 CFR Part 11 requirements, creating data integrity risk and audit exposure.
Validation Burden
Validation documentation that is incomplete, inconsistent with the installed system, or not maintained after changes, making IQ/OQ/PQ execution painful and time-consuming.
Containment Risk
Poor material containment controls creating cross-contamination risk between product campaigns: a critical issue in high-mix CDMO environments.
Batch Record Integrity
Batch record accuracy issues from manual data entry, system integrations that miss parameters, or process steps that aren't tracked.
High-Mix Inflexibility
Inflexible automation that slows changeover between products: a major constraint for CDMOs managing multiple clients on shared equipment.
Legacy Systems
Aging control systems that can't support the data logging, audit trail, or access control requirements of modern regulatory standards.
OUR FOUR CORE PILLARS FOR PHARMACEUTICAL AUTOMATION
Engineering for Compliance, Flexibility, and Repeatability
Compliance by Design
21 CFR Part 11, GMP, and GAMP 5 requirements can be built into system architecture from the specification phase. Access control, audit trails, electronic signatures, and data integrity measures as standards, not add-ons.
Validation-Ready Documentation
We produce the documentation your validation team needs per your SOPs: functional specifications, I/O lists, wiring diagrams, program backups, and instrument calibration records. We can also support development of IQ/OQ/PQ protocols.
Material Containment & Traceability
Containment interlocks, campaign management logic, material tracking from receipt to release, and batch genealogy. Engineered to prevent cross-contamination and prove traceability from raw material to finished product.
High-Mix Flexibility
Recipe-driven automation with parameter lockouts allows rapid changeover between products without re-programming. Ideal for CDMOs running multiple formulations on shared equipment with minimal downtime.
These four pillars define how Lineside approaches every pharma project: from first conversation to commissioning and beyond.
EQUIPMENT & SYSTEMS INTEGRATION
Pharma-Specific Equipment We Integrate With
Pharma plants run equipment most integrators have never touched: lyophilizers, autoclaves, isolators, particle counters, serialization printers. We integrate this hardware into your SCADA + historian + EBR so a single audit trail tells the whole batch story.
Aseptic Processing Equipment
Lyophilizers — GEA, IMA, SP Scientific
Vial & ampoule fillers — Bosch, Optima, Groninger
Isolators & RABS — Skan, Getinge
Autoclaves, SIP & tubing welders
Glove-port leak testers
Tubing welders / sealers
Environmental & Cleanroom Monitoring
Particle counters — TSI, Lighthouse, Met One
Viable air samplers — MAS-100, EMTEK
Vaisala T/RH + differential pressure
BMS / EMS — Honeywell, JCI, Siemens Desigo
Pure steam & WFI quality probes
BMS / EMS (Honeywell, JCI, Siemens Desigo)
Validation, MES & Compliance Stack
Werum PAS-X / OpenPath MES
Rockwell PharmaSuite + Ignition 21 CFR Part 11
Kneat & ValGenesis VLMS
OPC UA + ISA-95 / S88 batch + eBR
Ignition 21 CFR Part 11 module
Electronic Batch Records (eBR)
Serialization, Track & Trace, Devices
Vision — Cognex, Antares, Mettler-Toledo
Serialization printers — Domino, Videojet, Markem-Imaje
DSCSA + EU FMD aggregation + RFID
PI Historian + AVEVA Insight
Tamper-evidence sealers
PI Historian + AVEVA Insight
OUR CAPABILITIES
What We Can Do in Pharma & Life Sciences Manufacturing
We support control system integration, modernization, and turnkey projects across the pharmaceutical production lifecycle.
Areas where we can help:
API Containment and Control
- Batch reactor control
- CIP/SIP sequences
- Containment interlocks
Batch reactor control, temperature and pressure management, automated CIP/SIP sequences, containment interlocks, process parameter logging with full audit trails, and electronic batch record generation.
Formulation & Compounding
- Gravimetric dosing
- Recipe enforcement
- Batch traceability
Gravimetric dosing and dispensing control, recipe management with parameter enforcement, environmental monitoring integration, containment verification, and batch traceability from raw material through formulation.
Fill-Finish Operations
- Aseptic fill control
- Vision inspection
- Cleanroom monitoring
Aseptic fill line integration, fill-volume control and in-process weight checking, stopper/capper integration, vision inspection for container integrity, and cleanroom pressure and airflow monitoring.
Packaging & Serialization
- DSCSA track & trace
- Label verification
- Tamper evidence
Automated packaging line control, DSCSA + EU FMD-aligned serialization, label verification, tamper-evidence integration, and lot/expiry management.
Cleanroom & HVAC Control
- Differential pressure
- Particle monitoring
- Environmental alarms
Environmental monitoring (temperature, humidity, differential pressure, particle count), cleanroom HVAC cascade control, alarm management, and integration with Building Management Systems and EMS.
SCADA & Data Systems
- 21 CFR Part 11
- Electronic batch records
- Historian integration
21 CFR Part 11-compliant SCADA implementation (Ignition, FactoryTalk, WinCC, AVEVA), electronic batch records, OPC-UA integration with MES/ERP, historian integration, and audit trail configuration.
End-to-end control system integration across the pharma manufacturing lifecycle: built for compliance from day one.
INDUSTRY STANDARDS
Standards & Frameworks We Engineer To
Industry Framework
ISPE GAMP 5
Risk-based computer system validation
The international standard for validation of GxP computerized systems. Our design and documentation workflows align with GAMP 5 category 3, 4 and 5 software handling so your validation effort is structured, defensible, and audit-ready from day one.
Industry Framework
ALCOA+ Data Integrity
Attributable. Legible. Contemporaneous. Original. Accurate. + Complete, Consistent, Enduring, Available.
Every audit trail, electronic record and historian configuration we deliver is engineered around ALCOA+. Time-synchronized servers, role-based access, immutable logs and contemporaneous capture are configured at the SCADA and historian layers, not bolted on afterwards.
OUR APPROACH
How We Work with Pharma Clients
Pharmaceutical automation projects require a structured, disciplined approach. Here’s how we engage:
Discovery
We invest time understanding your process, your regulatory environment, your validation approach, and your operational constraints before proposing a solution.
Specification First
We produce function and design documents for your review before any programming begins.
Revision Control
We follow structured revision management practices throughout the project. Every change is documented, reviewed, and captured via revision control.
Clean, Auditable Code
Our code is clean, structured, and commented. We don’t write spaghetti logic that makes validation painful and future changes risky.
Complete Documentation
We produce complete deliverable packages: as-built drawings, I/O lists, program backups, calibration records, and all documentation required for IQ/OQ/PQ execution.
Ongoing Support
We remain available after commissioning for technical support, change management, and system health evaluations. Your needs don’t end at go-live.
WHY IT MATTERS
The Business Case for Validated Automation
Compliance failures aren’t just regulatory exposure. They’re production stoppages, rejected batches, delayed launches, and erosion of regulator trust that takes years to rebuild. Engineering compliance into your control systems from day one is the lowest-cost path to predictable, audit-ready production.
Audit-Ready
Validation packages built into project deliverables, not assembled at the last minute. Regulators see a system designed to be audited.
Lower Cost
Clean specifications, well-documented code, and predictable system behaviour cut validation cycle time and rework.
Faster
Recipe-driven, parameter-locked automation lets CDMOs run more product lines on the same equipment with less downtime.
ALCOA+
Tamper-evident audit trails and time-synchronized historian capture mean batch records hold up under regulatory scrutiny.
FREQUENTLY ASKED QUESTIONS
Common Questions from Pharma & Life Sciences Manufacturers
Pharma teams often start with these questions before bringing us into a project. If yours isn’t covered, just reach out.
How do you ensure our systems meet 21 CFR Part 11 requirements?
21 CFR Part 11 compliance is built into system architecture from the start, not retrofitted. Through the discovery process, we understand your needs and SOPs. This often means role-based access control with unique user IDs, electronic signatures with meaning and authority, tamper-evident audit trails that capture who changed what and when, time-synchronized clocks, and data integrity measures that prevent unauthorized modification of electronic records. We configure these elements in the SCADA and historian layers, and we document the configuration for your validation records.
We're a CDMO running multiple formulations. How does your automation handle high-mix production?
Recipe-driven automation is the answer. We implement master recipe libraries at the SCADA level with parameter lockouts that prevent operators from running off-specification processes. Product changeover is guided by the system, checklist-driven with interlock verification, reducing changeover time and human error risk. Each recipe is revision-controlled and access-restricted, so the right product gets the right parameters every time.
What documentation do you provide to support our validation effort?
We produce a comprehensive documentation package designed to support your IQ/OQ/PQ execution: functional design specification, detailed I/O list, electrical wiring diagrams, instrument calibration records, program documentation with annotated code, as-built drawings, and change logs. We can also work with your validation team to develop test protocols, or review protocols prepared by your team to ensure they’re aligned with the installed system.
How do you handle material containment for potent compounds or allergens?
Containment is addressed at the engineering level through interlock logic that enforces sequence requirements. For example, preventing a reactor from opening until containment conditions are confirmed, or requiring a validated cleaning cycle before a new campaign can begin. We design containment verification into the process control logic, and we log all containment-related events in the audit trail. For highly potent compounds, we can design for single-pass airflow, negative pressure confirmation, and containment breach alarming. We follow your lead on this topic; we aim to meet your SOPs or help you improve on your current systems.
We have legacy systems that aren't 21 CFR Part 11 compliant. Can you upgrade them without replacing everything?
Often, yes. We assess what’s in place and identify what needs to change to achieve compliance, which is frequently the HMI and SCADA layer rather than the PLC and field instruments. Adding a compliant historian, implementing user authentication, and configuring audit trails can often be accomplished without wholesale replacement of working control hardware. We’ll give you an honest assessment of what’s required and what the options are.
What SCADA platforms do you work with?
We work with Ignition (Inductive Automation), FactoryTalk View (Rockwell), WinCC (Siemens), and Wonderware. For pharmaceutical applications, Ignition is often our recommendation because of its native 21 CFR Part 11 compliance module, open architecture, and strong historian and reporting capabilities. We recommend the platform that best fits your compliance requirements, existing infrastructure, and long-term maintainability needs.
Let's Build Your Compliant Automation Foundation
Compliance, traceability, and validated performance, engineered from the start. Connect with our team for a no-obligation consultation.
1-888-845-7955 | [email protected] | 60 Ottawa St S, Kitchener, ON, N2G 3S7