Resources

Glossary

Schedule a Free Demo

A

AI Manufacturing

Artificial Intelligence (AI)

Augmented Reality (AR)

ALCOA

ALCOA+

Application Platform as a Service

Audit Trails

Accelerated Testing

Abbreviated New Drug Application

B

Batch Packaging Record (BPR)

Batch Control Record (BCR)

BMR in Pharma

Batch Manufacturing

Batch Record

Batch Record Management

Batch Manufacturing Record

C

Clinical Manufacturing

Cloud SaaS

Cloud Software

Cloud-Based MES

Cleaning Validation

Cleanroom in Pharma

Commercial Manufacturing

CAPA Management

D

Digital Manufacturing (DM)

Digital Transformation

Digital Work Instructions

Data Integration

Device Master Record (DMR)

Design Control

Deviation

Document Control

Design History File (DHF)

Device History Record (DHR)

Drug Master File (DMF)

Digital Twin Technology

E

eBMR

Electronic Batch Record (EBR)

Enterprise Resource Planning (ERP)

EU MDR

Electronic Signature

Electronic records

European Medicines Agency (EMA)

EUDAMED

EQMS

Electronic Health Records (EHR)

EU ANNEXURE 1

EU Annex 11

Environmental Management System

F

Form 483

FDA 21 CFR Part 11

G

Good Manufacturing Practice (GMP)

GAMP 5

Good Distribution Practice (GDP)

GxP

Good Clinical Practice (GCP)

Good Laboratory Practice (GLP)

Good Documentation Practice (GDocP)

H

Hybrid Cloud

Hybrid Infrastructure

I

ICH guidelines

ICH Q8

ICH Q9

ICH Q10

ICH Q11

Internet of Things (IoT)

Installation Qualification (IQ)

ISO 13485

ISO 15189

ISO 17025

In Vitro Diagnostics (IVD)

Infrastructure as a Service (IaaS)

Intermediate testing

L

LES System

LIMS System

LMS System

LQMS System

Lights-Out Manufacturing

Lean Six Sigma

Low Code/No Code

Log Deviation

Long Term Testing

M

MES System

Master Batch Record (MBR)

Mixed Reality (MR)

Medical Devices

MEDDEV 2.12

MEDDEV 2.7 rev

MAC (Maximum Allowable Carryover)

N

New Drug Application (NDA)

New Prouct Introduction (NPI)

Nonconformity NC

O

On-Premises Software

Operational Qualification (OQ)

Out of trend (OOT)

Out of Expectation (OOE)

Out of Specification (OOS)

P

Pharma 4.0

Preclinical Development

Private Cloud

Public cloud

PDCA Cycle

Premarket Approval (PMA)

Programmable Logic Controllers (PLCs)

Product Lifecycle Management (PLM)

Pharmaceutical Labelling

Preventive Action

Pharma Manufacturing Software

PADER

Pharmacopeia

Platform as a Service (PaaS)

Q

Quality Assurance

Quality by Design (QbD)

Quality Control

Quality Culture

Quality Functional Deployment (QFD)

Quality Management Software (QMS)

Quality Management Process (QMP)

Quality Risk Management (QRM)

R

Risk Assessment

Risk Based Thinking

Risk Matrix

Root Cause Analysis (RCA)

Root Cause Investigation (RCI)

Regulatory Compliance

S

Software as a Service (SaaS)

Standard Operating Procedures (SOP)

Statistical Process Control (SPC)

Stability

Six Sigma

Stability Protocol Report

Stability Study Report

Submission Tracking

Submission Validation

Shelf Life

Service Level Agreement (SLA)

Software as a Medical Device (SaMD)

T

Total Quality Management (TQM)

Time To Market

Three Sigma

U

US FDA

V

Virtual Reality (VR)

VoE and VoEP

Verification of Implementation (VoI)

Vendor Management