Digital Transformation and Automation

Digital Maturity Assessments and Automation Roadmap Navigating the shift toward Industry 4.0 (now 5.0) begins with a clear understanding of your current technological landscape. Our Digital Maturity Assessments provide a comprehensive evaluation of your existing systems, identifying critical operational gaps and opportunities for optimization. From there, we partner with your team to develop a strategic, phased Automation Roadmap that seamlessly integrates advanced digital workflows, reduces manual intervention, and sustainably scales your manufacturing operations for the future.

AI-Readiness To truly leverage the power of Artificial Intelligence in a regulated environment, your foundational data architecture must be robust, structured, and highly accessible. SAGE helps you navigate the complexities of AI-readiness by evaluating your current systemic capabilities and optimizing your data ecosystems to support advanced machine learning and predictive models. We ensure your facility is technologically prepared to deploy automated decision-making tools that drive efficiency without ever compromising strict GMP compliance.

Data Integrity, Computerized System Validation, and Serialization
In life sciences, the reliability of your digital records is just as critical as the quality of your physical product. We deliver turn-key Computerized System Validation (CSV) to guarantee your software, control systems, and automation platforms perform exactly as intended under regulatory scrutiny. By embedding steadfast Data Integrity (ALCOA+) principles and implementing secure tracking systems like Serialization, we safeguard your digital assets, ensure complete audit readiness, and provide full traceability across your entire pharmaceutical supply chain.

Digital Maturity Assessments and Automation Roadmap Navigating the shift toward Industry 4.0 (now 5.0) begins with a clear understanding of your current technological landscape. Our Digital Maturity Assessments provide a comprehensive evaluation of your existing systems, identifying critical operational gaps and opportunities for optimization. From there, we partner with your team to develop a strategic, phased Automation Roadmap that seamlessly integrates advanced digital workflows, reduces manual intervention, and sustainably scales your manufacturing operations for the future.

AI-Readiness To truly leverage the power of Artificial Intelligence in a regulated environment, your foundational data architecture must be robust, structured, and highly accessible. SAGE helps you navigate the complexities of AI-readiness by evaluating your current systemic capabilities and optimizing your data ecosystems to support advanced machine learning and predictive models. We ensure your facility is technologically prepared to deploy automated decision-making tools that drive efficiency without ever compromising strict GMP compliance.

Packaging

SAGE has completed new and existing (retrofit) automated equipment projects for many packaging formats, including bottles, blisters, tubes, and sachets. We develop equipment trains on Primary and Secondary packaging lines that reflect the capacity needed to meet our client’s increasing volume forecasts.

Key Projects

Equipment & Facility Engineering
Equipment
  • Reconfiguration of a small volume Nasal Packaging line, including crimp inspection station, PDC neckbander and shrink tunnel
Equipment & Facility Engineering
Automation
  • Equipment engineering and IT integration lead for an automated OEE system installed on multiple solid-dose packaging lines, including installation and commissioning

Processes

SAGE has ability to learn client specific processes quickly and work with equipment vendors and OEMs to integrate automated solutions that meet quality, functional and technical requirements. Converting a manual process to an automated one requires an in-depth knowledge of equipment limitations, risk-based methodology for testing critical functions, and integration with upstream and downstream processes.

Key Projects

Equipment & Facility Engineering
Facilities
  • Design and calculations for Control System enclosure purging system to reduce explosive atmosphere
Compliance & Validation
Equipment
  • IQ/OQ for a Clean in Place (CIP) system for a large-scale batch process

Project Management

  • Equipment
  • Developed an automated solution for a medical test cartridge assembly process, including process design, specification development, and vendor management
Inspections
A machine vision system can eliminate the need for tedious manual inspection of products. However, automated detection performance should be closely aligned with that of manual operators in order to successfully validate the system. The primary benefits of switching to an automated inspection system are repeatability and speed. Also, defects found by the machine can be evaluated and upstream processes can be corrected to eliminate rework and waste. SAGE has successfully designed, installed, and qualified Vision Systems from individual devices all the way to integrated enterprise systems to inspect products for foreign particulate, container integrity, lot ID and expiry date identification, cosmetic defects, and correct fill level / count.

Key Projects

Equipment & Facility Engineering

  • Equipment
  • Clinical batch project for topical medication, including new mixing tanks, in-line powder disperser, and tube filler

Equipment & Facility Engineering

  • Facilities
  • Large-scale project for Topical Aerosol Foam products with flammable liquid, including dispensing of OHC Category 4 and 5 compounds within a containment isolator

Equipment & Facility Engineering

  • Process
  • Design, installation and validation of automated inspection machines for injectable drugs

Compliance & Validation

  • Equipment
  • Vision system for automated inspection of tubes to verify quality attributes, including contamination, tube diameter, crimp seal, and Lot/Exp presence

Project Management

  • Equipment
  • Large-scale project for a topical pain medication scale-up, including infrastructure, manufacturing and packaging readiness to develop capacity of 30 million tubes annually
Data Integrity
With the growing amount of data being used to measure metrics, evaluate support and so forth, the importance of its integrity is brought to the forefront. Often the subject of audits, computerized systems must be validated and its data authenticated, time stamped, and traceable. The transition from massive amounts of paperwork to digital systems brings undeniable advancement and value to companies. It also brings many rules and policies to ensure the data is contemporaneous and authentic. SAGE has successfully designed, audited, and qualified computerized systems to be compliant as per industry regulations.

Key Projects

Compliance & Validation
  • Process
  • Reviewed, tested and confirmed software design standards compliance to GAMP5 methodology for Track and Trace software solutions, from Line Equipment to ERP system

Compliance & Validation

  • Equipment
  • Change control managed and re-qualified multiple upgraded production equipment to be compliant with updated data integrity regulations

Compliance & Validation

  • Process
  • Design, installatiImplemented a new Artwork Management System, including GxP Applicability Assessment, Supplier Audit, User Requirements Specification and Performance Qualification (PQ)on and validation of automated inspection machines for injectable drugs

Project Management

  • Process
  • Design, configuration and testing of user access levels with integration to client’s LDAP server
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