Automated Systems,Inc.

What Automated Systems,Inc. does

Automated Systems, Inc. (ASI) is a US professional-services firm founded in 1989 and headquartered in Lake Bluff, Illinois, with a Southeast Regional Office in Tampa, Florida. The firm is organized around three service groups — FDA Compliance, Manufacturing Intelligence, and Project Professionals — that together deliver an integrated mix of regulatory expertise (validation, 21 CFR Part 11, GAMP5, data integrity, ALCOA, DSCSA serialization, 483/Warning Letter response), industrial automation (PLC, HMI, SCADA, DCS design and integration, MES, motion control), and manufacturing intelligence (data historians, dashboards, OEE/energy/real-time performance reporting), complemented by technical staffing for FDA-regulated environments.

The company is positioned as a tiered systems integrator, holding Certified Solution Provider status with Rockwell Automation, Wonderware/AVEVA, and InduSoft, and operating strategic alliances with Middough Inc. (2017) and R+D Custom Automation (2015). Its primary vertical is life sciences (pharmaceutical, medical device, biotech, API manufacturers), with secondary practices in health & beauty, food & beverage, parcel handling, and OEM machinery. The platform combines automation, regulatory consulting, and billable technical staffing — a configuration that lets ASI enter client engagements either as prime compliance/automation consultant or as embedded staff augmentation.

Revenue is generated entirely through professional services: project-based consulting, time-and-materials engineering engagements, retainer advisory work, and billable consultant placements. Go-to-market is sales-led and relationship-driven, with direct outreach, inside sales via phone (844-HIRE-ASI), website lead capture, event sponsorships (ISPE GAMP Forum, Rockwell Automation Fair), and association presence (ISPE, ASQ, ISA, BioFlorida, Chicago Freedom Summit). The 51-100 employee firm is privately held and founder-led by President Laszlo Kulcsar, with CEO Ray Rugebregt, COO Nels Hackl, and a management bench averaging 25-30+ years of FDA-regulated industry experience; no outside investment or parent entity is disclosed.

Name

Automated Systems,Inc.

Legal name

Automated Systems, Inc.

Website

https://automatedsys.com

Company type

Private

Founded year

1989

Operating status

Operating

Headcount range

51–100 employees

Short description

Automated Systems, Inc. is a US professional-services firm delivering FDA compliance consulting, systems automation (PLC/HMI/SCADA/DCS), manufacturing intelligence, and technical staffing primarily to pharmaceutical, medical device, and biotech manufacturers across the United States.

Ownership category

akta.pro rank

Product category

Life Sciences Compliance & Systems Integration Services

NAICS

Instruments and Related Products Manufacturing for Measuring, Displaying, and Controlling Industrial Process Variables (334513), Navigational, Measuring, Electromedical, and Control Instruments Manufacturing (3345)

SIC

Industrial Instruments For Measurement, Display, And Control (3823)

akta.pro primary industry

Process Automation Instrumentation & Control (DCS, Valves, Actuators, Analyzers) (IMAHAHAM)

akta.pro secondary industries

Compliance Technology, GRC Platforms & Controls Automation Advisory (BPAHAFAO), Regulatory Affairs, Labeling & Advertising/Promotion Compliance (HLAJADAI), Lab Automation, Instrument Control & Workflow Orchestration Software (HLAGAJAG)

Keywords

• FDA compliance consulting
• Systems integration services
• PLC SCADA automation
• Pharmaceutical validation services
• Technical staffing solutions

Headquarters

HQ city

Lake Bluff

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D, Infrastructure

Revenue model

1. Technical Staffing Services: Provides skilled technical professionals for project management, technology transfer, validation/qualification, quality assurance, regulatory affairs, equipment/facility engineering, automation, instrumentation and controls, software development, database development, data analytics, and real-time performance management. Revenue generated through billable consultant placements.
2. FDA Compliance Consulting: Consulting services for FDA regulations including 483 and Warning Letter response, quality systems, risk management, validation, data integrity, software qualification, auditing and assessment, and project management. Project-based or retainer engagements.
3. Systems Automation Services: Plant automation services including PLC programming, HMI/SCADA development, MES systems, network analysis, servos and drives, infrastructure testing, and network design. Revenue from engineering services and integration projects.
4. Data Analytics Services: Manufacturing intelligence including data historians, dashboards, OEE reporting, energy efficiency monitoring, real-time performance systems, production data collection and visualization, and asset management.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels5 records

Core offering

Automated Systems, Inc. provides FDA compliance and validation consulting, industrial systems automation (PLC, HMI, SCADA, DCS, MES integration), manufacturing intelligence and data analytics (data historians, OEE dashboards, real-time performance management), and technical staffing for highly regulated manufacturers. Its offerings are organized into three groups—FDA Compliance Group, Manufacturing Intelligence Group, and Project Professionals Group—serving pharmaceutical, medical device, biotech, food & beverage, health & beauty, parcel handling, and OEM machinery clients across the United States.

Product overview

ASI is a systems integrator providing a portfolio of professional services organized into three core groups: FDA Compliance Group (quality systems, validation, data integrity, 21 CFR Part 11 expertise), Manufacturing Intelligence Group (plant-wide information architecture, data historians, dashboards, OEE reporting), and Project Professionals Group (technical staffing). Services span systems automation (PLC, HMI, SCADA, DCS), data analytics, FDA compliance consulting, and technical staffing. The company serves highly regulated industries including life sciences (pharmaceutical, medical device, biotech), health & beauty, food & beverage, parcel handling, and OEM machinery.

Differentiator

Problem solved

Functional benefit

Products and services

• Systems Automation Plant automation solutions including PLC, HMI, SCADA, and DCS design, development, and systems integration; services span installed base evaluation, network analysis, motion control, and infrastructure testing for life sciences, parcel handling, and other regulated manufacturers.
• FDA Compliance Services FDA regulatory compliance consulting including 483 and Warning Letter response, quality systems, risk management, validation, data integrity, software qualification, auditing, gap assessments, and project management for FDA-regulated industries.
• Data Analytics Manufacturing intelligence services including data historians for long-term retention, dashboards for visualization, OEE reporting, energy efficiency monitoring, real-time performance calculation, production data collection, and asset management.
• Technical Staffing Skilled technical staffing for FDA-regulated industries, providing project management, technology transfer, validation/qualification, quality assurance, regulatory affairs, automation, instrumentation and controls, software and database development, data analytics, and real-time performance management professionals.
• Life Sciences Industry Services Tailored FDA compliance and process automation services for pharmaceutical, medical device, biotech, and API manufacturers, including equipment/facility/utility validation, computer system validation, data integrity, product serialization, and process automation.
• FDA 483 & Warning Letter Response Expert guidance and action plans for responding to FDA Form 483 inspectional observations and Warning Letters, including remediation support and quality system deficiency remediation for FDA-regulated manufacturers.

Quantifiable outcome

• Over 500 years of combined executive and management team experience
• +1 more outcomes

Named customers4 records

Segments5 records

Ideal customer profiles2 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration8 records

AI capability3 records

Feature4 records

Partnerships

Nine partnerships are on record, tiered core and minor.

• Middough Inc.coreStrategic or Co-development Partner · 20 February 2017Automated Systems, Inc. entered into a strategic alliance with Middough Inc., a nationally ranked engineering, architectural, and management services company. ASI will ally with Middough to provide FDA compliance documentation and high-level software support. This alliance combines the strengths of both firms to better serve life sciences clients.
• R+D Custom AutomationcoreStrategic or Co-development Partner · 20 November 2015Automated Systems, Inc. and R+D Custom Automation, Inc., one of the area's leading OEMs for custom pharmaceutical and medical device manufacturing systems, entered into a strategic partnership. ASI provides FDA compliance documentation and high-level software support to complement R+D's fully integrated custom automation solutions.
• Rockwell AutomationcoreTechnology or IntegrationASI is a certified Solution Provider for Rockwell Automation. To become a Rockwell Automation system integrator, companies must possess the knowledge, resources, and skills required to deliver world-class manufacturing solutions. Customers can feel confident in choosing a Rockwell Automation Solution Provider because each must possess high corporate standards, financial stability, and competency on Rockwell Automation technologies as well as a commitment to the partnership.
• Wonderware (AVEVA)coreTechnology or IntegrationASI is a Wonderware System Integrator. Wonderware is the market leader in real-time operations management software. Wonderware software delivers significant cost reductions associated with designing, building, deploying, and maintaining secure and standardized applications for manufacturing and infrastructure operations.
• InduSoftcoreTechnology or IntegrationASI is a certified System Integrator for InduSoft. InduSoft delivers powerful HMI and SCADA software with innovative tools to rapidly build operator interface, SCADA, HMI, or embedded applications across a wide range of industries. Founded in 1997, InduSoft has more than 125,000 systems operating worldwide.
• ISPE (International Society of Pharmaceutical Engineers)minorStrategic or Co-development PartnerASI proudly supports the International Society of Pharmaceutical Engineers, the world's largest not-for-profit association serving its Members by leading scientific, technical, and regulatory advancement throughout the entire pharmaceutical lifecycle. ASI sponsors ISPE Great Lakes Chapter events.
• BioFloridaminorStrategic or Co-development PartnerASI is a proud member of BioFlorida; the voice of Florida's life sciences industry, representing 6,700 establishments and research organizations in the BioPharma, MedTech, HealthIT & BioAg that collectively employ nearly 94,000 Floridians.
• ASQ (American Society for Quality)minorStrategic or Co-development PartnerASI personnel are members of the ASQ. ASQ is committed to providing enhanced expertise, professional networks, tools, and solutions to help members advance their products, services, and industries.
• ISA (International Society of Automation)minorStrategic or Co-development PartnerThe International Society of Automation (ISA) is a non-profit professional association of engineers, technicians, and management engaged in industrial automation. As the globally trusted provider of foundational standards-based technical resources for the profession, ISA strives to build a better world through automation.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Real Staffing (SThree): Real Staffing is a life sciences-focused talent solutions provider placing regulatory, quality, validation, and clinical professionals. It is a direct competitor to ASI's Project Professionals technical staffing group.
• PharmEng Technology: PharmEng Technology provides pharmaceutical consulting services spanning validation, GMP compliance, regulatory affairs, and engineering. It is a direct competing services boutique to ASI's life sciences practice.
• Commissioning Agents Inc. (CAI): CAI provides commissioning, qualification, and validation services along with technical staffing for life sciences manufacturers. It competes with ASI's validation services and Project Professionals Group for pharma clients.
• PSC Biotech: PSC Biotech is a life sciences consulting firm offering computer system validation, commissioning/qualification, and FDA compliance services to pharma, biotech, and medical device manufacturers. It overlaps with ASI most directly on the FDA compliance and validation services side.
• Concept Plus (now part of Axiom): Concept Plus provided FDA-regulated IT/CSV validation and compliance services to federal agencies and life sciences clients, closely comparable to ASI's FDA Compliance Services group prior to its acquisition by Axiom.

Broad incumbents

• Clarkston Consulting: Clarkston Consulting is a management and technology consultancy serving consumer products and life sciences clients on validation, regulatory, and ERP/IT initiatives. It overlaps with ASI on the FDA compliance and systems integration work but also extends into broader transformation work.
• CRB Group: CRB is a global engineering, architecture, and consulting firm specializing in life sciences facility design, construction, and process automation. It overlaps with ASI's systems automation and FDA-compliance practice for biotech and pharma clients, though at a larger, integrated scale.
• Kforce Inc. (Life Sciences Staffing): Kforce is a large public staffing firm with a dedicated Life Sciences vertical supplying validation, regulatory, quality, and clinical professionals. It overlaps with ASI's technical staffing offering but operates at a much broader scale and across multiple industries.
• Stantec (Life Sciences): Stantec is a multi-disciplinary engineering consultancy with a significant Life Sciences practice covering validation, commissioning, and process automation. It is a much larger full-service incumbent competing for the same mid-market pharma projects as ASI.

Regional players

• NNE A/S: NNE is a Novo Nordisk-affiliated engineering consultancy specializing in pharma process design, GMP compliance, and automation. It is a strong functional peer to ASI but is primarily Denmark/Nordics-based, limiting direct US overlap.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/automated-systems-inc-

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Automated Systems,Inc.