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Bridging automation, computerized systems, compliance across regulated environments

Overview

Reliable Systems. Compliant Data. Connected Operations.

Modern life sciences operations depend on automation and digital systems that are reliable, secure, validated, and aligned with GMP expectations. From manufacturing controls to facility monitoring and laboratory systems, these platforms play a critical role in product quality, data integrity, operational visibility, and inspection readiness.

AVEX supports clients across automation, computerized systems, and digital compliance programs. Our team helps bridge the gap between engineering, IT, quality, validation, operations, vendors, and system owners to keep systems functional, documented, compliant, and production-ready.

Automation and controls systems in a GMP manufacturing environment

Core Service Areas

Automation & Digital Compliance Services

Automation Engineering

Automation Engineering Support

Configuration, troubleshooting, startup, commissioning, alarm review, recipe support, control logic coordination, and vendor/system interface activities.

Computerized System Validation

Computerized System Validation / CSA

Validation planning, risk assessment, requirements, test scripts, execution, traceability, and final reporting for GMP computerized systems.

BMS / EMS Support

User access review, alarm review, trend review, sensor integration, environmental data review, and qualification/validation documentation.

MES / LIMS Support

Requirements, workflow review, testing, data integrity, user access, role-based permissions, and lifecycle documentation.

Data Integrity & Part 11

Data Integrity & 21 CFR Part 11

Audit trails, electronic records, signatures, access controls, security roles, backup/restore, and ALCOA+ expectations.

System Lifecycle Documentation

URS, FS, DS, validation plans, IQ/OQ/PQ, RTM, SOPs, work instructions, periodic reviews, and validation summary reports.

IT/OT Integration Support

Coordination across IT, OT, automation, quality, engineering, validation, and operations for reliable, compliant system implementation.

Operational Troubleshooting

Operational Troubleshooting & Improvement

System issues, alarms, process interruptions, communication failures, access issues, audit trail concerns, and continuous improvement.

Life Cycle

Digital Compliance Lifecycle

Use this as a six-step flow unique to this page — a progressive lifecycle with clear checkpoints from assessment through sustain.

Six Lifecycle Checkpoints

Assess

System, GMP impact, data flow, user needs, and current documentation status.

20%

Define

Requirements, boundaries, critical functions, data integrity needs, and validation strategy.

40%

Configure

Interfaces, automation, alarms, recipes, workflows, dashboards, and system integration.

60%

Validate

CSV/CSA testing, qualification protocols, security testing, and traceability review.

80%

Operate

SOPs, training, alarm management, access control, issue resolution, and routine monitoring.

100%

Sustain

Change control, periodic review, revalidation, and continuous improvement.

Systems AVEX Supports

Systems We Support

PLC / Control Systems

Programmable logic controllers for manufacturing equipment, utilities, and process skids.

SCADA / HMI Systems

Operator interfaces, visualization, alarms, recipes, and access controls.

BMS / EMS Systems

HVAC, cleanrooms, differential pressure, temperature, and alarms.

MES / Manufacturing Systems

Batch records, workflow execution, and production data tracking.

LIMS / Laboratory Systems

Sample workflows, test data, lab execution, and data integrity.

Historians & Data Platforms

PI Historian, trends, alarm records, and GMP data visibility.

Utility & Facility Systems

WFI, clean steam, HVAC, compressed gases, cold storage, and infrastructure.

Manufacturing & Packaging Equipment

Filling lines, autoclaves, lyophilizers, isolators, and GMP assets.

How AVEX Helps

Practical Support Across Engineering, IT, Quality, and Operations

Automation and digital compliance work often fails when teams operate in silos. AVEX helps connect the right stakeholders, clarify system requirements, support execution, and maintain documentation that stands up to internal and regulatory review.

Bridge IT and OT needs by helping engineering, automation, IT, quality, validation, and operations align around system use and compliance expectations.

Support GMP system implementation through requirements, configuration review, commissioning support, validation execution, and documentation.

Strengthen data integrity controls by reviewing audit trails, access roles, electronic records, electronic signatures, backup practices, and system permissions.

Improve system reliability through troubleshooting support, alarm review, issue resolution, and operational improvement activities.

Maintain lifecycle compliance through change control, periodic review, SOP updates, traceability, and inspection-ready documentation.

Engineer reviewing automation system on tablet in GMP facility

Business Impact

Why It Matters

Automation and digital systems directly affect product quality, process control, environmental monitoring, laboratory data, manufacturing execution, and regulatory compliance. Weak system controls, poor documentation, or unreliable automation can lead to downtime, data integrity concerns, deviations, audit findings, and operational delays.