A

  • Asset Lifecycle Tracking 

    Asset Lifecycle Tracking is a comprehensive process used to monitor and manage an asset from its initial acquisition through to its final disposal. This includes tracking every significant stage, such as procurement, operational use, maintenance, upgrades, and eventual decommissioning or replacement.

  • Asset Management

    Asset management in manufacturing involves the coordinated activities of an organization to realize value from its assets. This includes tracking and monitoring physical assets, ensuring timely maintenance, and optimizing asset utilization to enhance productivity and operational efficiency.

  • Asset Register 

    An asset register is a centralized database or system that records all physical assets owned, leased, or used by an organization. It includes essential information such as asset location, purchase date, current value, condition, maintenance history, and depreciation schedules.   In manufacturing, particularly in medical device and pharmaceutical production, an asset register tracks critical equipment, machinery, tools, and instruments necessary for production.

  • Asset Tracking

    Asset tracking is the process of monitoring and managing physical assets within an organization, such as equipment, machinery, tools, and inventory. It involves using various methods and technologies to keep track of asset locations, conditions, usage, and maintenance schedules to ensure optimal utilization and management of assets. 

  • Audit Trail

    An audit trail is a chronological record that captures every action, transaction, and change made in a manufacturing process. It documents who acted, what changes were made, when they occurred, and sometimes, the reason behind those changes.   In a manufacturing environment, particularly in highly regulated industries like medical device production, an audit trail provides a robust method of ensuring traceability and accountability across all operational stages.

  • Automated Maintenance Scheduling

    Automated Maintenance Scheduling refers to the use of software solutions to automate the planning, assigning, and managing of maintenance tasks for machinery and equipment within a manufacturing operation.  Rather than relying on manual scheduling methods, automated systems take advantage of data from equipment sensors, pre-determined intervals, or usage conditions to ensure timely and efficient maintenance. These systems generate work orders, assign tasks to the appropriate personnel, and track completion.

B

  • Batch Record

    A batch record is a detailed and comprehensive document that captures every aspect of the manufacturing process for a specific product batch. This includes step-by-step instructions, the equipment used, materials consumed, operators involved, and all quality control checks performed during production.   Batch records are crucial in regulated industries, such as pharmaceutical and medical device manufacturing, as they serve as official documentation proving that products were manufactured according to approved procedures, standard operating procedures (SOPs), and regulatory requirements.

C

  • cGMP 

    Current Good Manufacturing Practices (cGMP) are regulations enforced by regulatory agencies such as the FDA (Food and Drug Administration) to ensure that products are consistently produced and controlled according to quality standards. cGMPs cover all aspects of production, from the raw materials, facilities, and equipment to the staff’s training and personal hygiene.

  • Change Control

    Change Control is a structured and formal process for managing modifications or adjustments within manufacturing operations. This process involves documenting, evaluating, and approving proposed changes to various aspects such as processes, equipment, software, or documentation to ensure they are controlled and traceable.

  • Compliance Management 

    Compliance management ensures that a manufacturing organization adheres to all relevant laws, regulations, standards, and internal policies. It involves systematically planning, implementing, and monitoring practices and procedures to guarantee compliance with legal and regulatory requirements.

  • Computerized Maintenance Management System (CMMS)

    A CMMS is a software solution that automates and organizes maintenance management processes. It provides tools for scheduling preventive maintenance, managing work orders, tracking asset history, and generating reports.

  • Condition Monitoring  

    Condition monitoring is a systematic approach used to evaluate the operational health of machinery in manufacturing environments. It involves the continuous or periodic collection of data related to equipment performance through sensors and analytical tools.

  • Condition-Based Maintenance (CBM) 

    Condition-Based Maintenance (CBM) is a proactive maintenance strategy that relies on monitoring the real-time condition of equipment to determine when maintenance should be performed. Unlike traditional preventive maintenance, which follows a fixed schedule, CBM bases maintenance decisions on actual equipment performance data.   This approach uses sensors and diagnostic tools to monitor various indicators—such as temperature, vibration, pressure, or oil quality—to detect early signs of wear or potential failure.

  • Contamination Control

    Contamination control is the comprehensive and systematic process to prevent, reduce, and eliminate contaminants in manufacturing environments. In medical manufacturing, this concept takes on an elevated level of importance due to stringent regulatory demands and the potential risk to patient safety.   Contaminants can enter the production process through various sources, including airborne particles, microorganisms, chemicals, and human contact.

  • Corrective and Preventive Action (CAPA)

    Corrective and Preventive Action (CAPA) is a systematic approach used in manufacturing to identify, investigate, and address the root causes of non-conformities or issues that arise during production.   CAPA is a critical component of quality management systems and is designed to solve two key problems: corrective actions resolve existing issues, while preventive actions mitigate the potential for similar problems to arise. This dual approach ensures that manufacturers fix current problems and continuously improve their processes to avoid recurrence.   CAPA is particularly crucial in regulated industries like medical device manufacturing, where compliance, product safety, and traceability are essential to ensure patient safety and meet regulatory standards. 

D

  • Data-Driven Maintenance 

    Data-Driven Maintenance is an advanced approach to equipment upkeep that relies on the continuous collection and analysis of real-time data to determine the optimal timing and type of maintenance activities. This method differs from traditional maintenance, which is typically scheduled based on fixed intervals or equipment failure.   Instead, Data-Driven Maintenance leverages IoT sensors, performance metrics, and historical data to monitor the actual condition of assets.

  • Documentation Control

    Documentation control is the systematic management and oversight of all documents within a manufacturing operation. This includes creating, reviewing, approving, distributing, revising, and storing critical documents, such as standard operating procedures (SOPs), work instructions, batch records, and design specifications.   Documentation control ensures that the latest, most accurate versions of documents are available to the right people at the right time, supporting compliance, operational consistency, and quality management.

  • Downtime Tracking

    Downtime tracking is the systematic process of recording and analyzing periods when production equipment is not operational. This includes scheduled downtime (e.g., maintenance) and unscheduled downtime (e.g., equipment failures).

E

  • Equipment Calibration 

    Equipment Calibration is the process of adjusting and validating the accuracy of instruments and equipment by comparing their measurements to a known, traceable standard. Calibration ensures that manufacturing tools and devices—such as temperature sensors, pressure gauges, flow meters, and weighing scales—consistently provide precise measurements.   In manufacturing, these instruments are crucial for maintaining the quality of products, monitoring production processes, and ensuring safety.

  • Equipment Validation  

    Equipment validation is a critical process in manufacturing that ensures machinery, tools, and systems function consistently and accurately, meeting operational and regulatory specifications. It involves a series of documented assessments, tests, and qualifications designed to verify that equipment is installed, operates, and produces results according to predetermined standards.   This process is particularly vital in industries such as medical manufacturing, where safety, accuracy, and regulatory compliance are paramount.

F

  • Facility Management Software

    Facility management software (FMS) is a comprehensive solution that helps manufacturing organizations manage their facilities more effectively. It provides tools for maintenance management, space management, asset tracking, and compliance monitoring, among other functions.

  • Failure Mode and Effects Analysis (FMEA)

    Failure Mode and Effects Analysis (FMEA) is a systematic approach to identify potential failure modes in a system, process, or product and assess their impact on operations, safety, and reliability. It involves analyzing the causes and effects of each failure mode and prioritizing them based on their severity, occurrence, and detectability.

  • FDA 21 CFR Part 11

    21 CFR Part 11 is a regulation set by the U.S. Food and Drug Administration (FDA) that establishes the criteria for electronic records and electronic signatures to be considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.

G

  • Good Documentation Practices (GDP)? 

    Good Documentation Practices (GDP) are standardized guidelines and principles designed to ensure the consistent creation, management, and retention of documentation within manufacturing operations.   GDP covers every phase of the documentation lifecycle, from initial drafting to archiving, ensuring that records are accurate, legible, and easily traceable. This controlled documentation system is essential in maintaining product quality, supporting regulatory compliance, and promoting operational efficiency.   In highly regulated sectors such as pharmaceutical and medical device manufacturing, GDP is critical in upholding compliance with regulatory frameworks like FDA 21 CFR Part 11 and ISO 13485, where stringent documentation practices are mandatory. 

  • Good Manufacturing Process

    Good manufacturing process (GMP) is a comprehensive set of guidelines and regulations that ensure the quality and safety of manufactured products. These guidelines cover all aspects of production, from the raw materials, premises, and equipment to the training and personal hygiene of staff.

I

  • Inventory Asset Management 

    Inventory asset management systematically oversees, controls, and optimizes an organization’s storage, movement, and inventory usage. It encompasses tracking inventory levels, managing stock locations, ensuring adequate supply without overstocking, and maintaining accurate records of inventory transactions.

L

  • Lifecycle Asset Management

    Lifecycle asset management refers to the comprehensive process of managing the entire lifecycle of an asset, from acquisition and deployment to maintenance and eventual disposal. Lifecycle asset management encompasses all stages of an asset’s life, ensuring that each phase is handled efficiently and effectively.

M

  • Maintenance Backlog

    A Maintenance Backlog refers to the accumulation of incomplete maintenance tasks that are awaiting completion. These tasks can vary from routine preventive maintenance to more urgent corrective actions, inspections, repairs, and equipment replacements.

  • Maintenance History

    Maintenance history refers to the comprehensive record of all activities performed on equipment and machinery within an organization. This includes details of preventive, predictive, and corrective maintenance tasks, as well as any inspections, repairs, and replacements that have taken place.

  • Maintenance Management Systems

    A maintenance management system (MMS) is software designed to streamline and manage a company’s maintenance activities, specifically within manufacturing operations. It helps plan, schedule, track, and optimize maintenance tasks to ensure that equipment and facilities are kept in optimal working condition.

  • Maintenance Schedule 

    A maintenance schedule is a meticulously planned timetable that outlines the specific tasks, frequencies, and responsibilities necessary for performing regular maintenance activities on equipment, machinery, and systems within a manufacturing operation. The schedule ensures that all assets are maintained in optimal working condition, thus minimizing downtime and extending the lifespan of equipment.

O

  • Overall Equipment Effectiveness (OEE)  

    Overall Equipment Effectiveness (OEE) is a comprehensive metric that assesses the efficiency and productivity of manufacturing equipment. As a key performance indicator (KPI), it evaluates how effectively a machine or production line is being utilized, factoring in availability, performance, and quality.

P

  • Planned Maintenance System

    A Planned Maintenance System is a structured approach to maintenance management where maintenance activities are scheduled and performed at predetermined intervals. This system ensures that equipment and machinery are regularly serviced to prevent unexpected breakdowns and to maintain optimal operating conditions.

  • Predictive Maintenance

    Predictive maintenance (PM) is a proactive maintenance strategy that uses data analysis, predictive algorithms, and various monitoring technologies to predict equipment failures before they occur. By identifying patterns and trends that indicate potential failures, predictive maintenance allows for maintenance to be conducted only when necessary rather than on a fixed schedule or after a failure, thereby extending the lifespan of assets and enhancing operational efficiency.

  • Preventive Maintenance

    Preventive Maintenance (PM) is the systematic and routine maintenance of equipment and machinery in manufacturing to ensure operational efficiency and prevent unexpected breakdowns. Unlike reactive maintenance, which addresses issues after they occur, preventive maintenance focuses on preventing equipment failures, maintaining optimal operating conditions, identifying issues before they arise, and ensuring that machinery performs its intended functions efficiently.

  • Process Validation  

    Process validation is a systematic, documented procedure to ensure that a manufacturing process consistently produces products that meet predetermined quality standards. It is a critical component of quality assurance, particularly in industries like pharmaceuticals, medical devices, and food manufacturing, where product safety, efficacy, and regulatory compliance are paramount.   Process validation is how manufacturers demonstrate that their processes can consistently deliver a product that meets specifications.

Q

  • Quality Assurance (QA) 

    Quality Assurance (QA) is the systematic process of ensuring that products meet specified quality standards throughout the manufacturing cycle. This involves developing, implementing, and overseeing procedures that prevent defects and inconsistencies from entering the production line.

R

  • Regulatory Compliance 

    Regulatory compliance refers to the adherence to laws, regulations, guidelines, and specifications relevant to a business or industry. In the manufacturing sector, regulatory compliance ensures that companies operate within the legal framework and adhere to industry-specific standards to maintain product quality, safety, and environmental stewardship. 

  • Reliability-Centered Maintenance (RCM)  

    Reliability-Centered Maintenance (RCM) is a systematic and structured approach to maintenance that focuses on identifying potential equipment failures and developing strategies to prevent them. RCM evaluates each piece of equipment within a manufacturing operation to determine its role, possible failure modes, and the consequences of those failures.   By tailoring maintenance strategies to each machine’s specific needs, RCM ensures that critical assets function efficiently, minimizing risks and avoiding unnecessary maintenance tasks.

W

  • Work Order Management

    Work order management is creating, assigning, tracking, and completing maintenance tasks within an organization. Work order management involves the systematic handling of maintenance requests and tasks from initiation to completion.