Topics should cover the financial impact of data management systems on drug development, manufacturing, and distribution; the basic computer system life cycle model as well as the activities and software quality assurance practices in each phase; and the controls and methods necessary to maintain data integrity and security.

Navigating Data Integrity and 21CFR.11
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Navigating Data Integrity and 21CFR.11
As widely accepted, a complete record-keeping system installed within Good Manufacturing Practice (GMP) environments may be validated to meet the requirements of 21CFR.11 and Annex 11-compliant operations. The 7000RMS Microbial Detection Analyzer is designed to meet the needs of such validation of...
Reimagining CPV for a Pharma 4.0™ World
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Reimagining CPV for a Pharma 4.0™ World
The life cycle approach to process validation stresses the need for continued monitoring of process performance to ensure that the manufacturing process remains stable and predictable, i.e., in a state of control. This life cycle stage is known as continued process verification (CPV) or ongoing...
eConsent Technology
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eConsent Technology
Tips for Tailoring eConsent for Optimal Patient Centricity. While informed consent is a critical process for ensuring participant autonomy in clinical research, consent forms are too long, unclear, difficult to read, and frequently exceed 9th grade reading levels. This has been demonstrated in...
Figure 1: Key characteristics of the ISO/IEC 25010:2011 product quality model
Features
Quality Agreements for SaaS Solutions Intended for GxP Use
As adoption of cloud technology continues to increase across the life sciences industry, so too does the need to establish a standardized and pragmatic approach for ensuring the quality of software applications used in support of GxP data and associated processes. This article focuses on the...
Navigating Data Integrity and 21CFR.11
Sponsored Content
Navigating Data Integrity and 21CFR.11
As widely accepted, a complete record-keeping system installed within Good Manufacturing Practice (GMP) environments may be validated to meet the requirements of 21CFR.11 and Annex 11-compliant operations. The 7000RMS Microbial Detection Analyzer is designed to meet the needs of such validation of...
Reimagining CPV for a Pharma 4.0™ World
Features
Reimagining CPV for a Pharma 4.0™ World
The life cycle approach to process validation stresses the need for continued monitoring of process performance to ensure that the manufacturing process remains stable and predictable, i.e., in a state of control. This life cycle stage is known as continued process verification (CPV) or ongoing...
eConsent Technology
Sponsored Content
eConsent Technology
Tips for Tailoring eConsent for Optimal Patient Centricity. While informed consent is a critical process for ensuring participant autonomy in clinical research, consent forms are too long, unclear, difficult to read, and frequently exceed 9th grade reading levels. This has been demonstrated in...
Figure 1: Key characteristics of the ISO/IEC 25010:2011 product quality model
Features
Quality Agreements for SaaS Solutions Intended for GxP Use
As adoption of cloud technology continues to increase across the life sciences industry, so too does the need to establish a standardized and pragmatic approach for ensuring the quality of software applications used in support of GxP data and associated processes. This article focuses on the...
Multivariate Inter-stage Batch Profile Monitoring
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Multivariate Inter-stage Batch Profile Monitoring
and Future State Estimation for Efficient Control and Planning of Manufacturing Operations As process engineers supporting multistage biologics manufacturing, we must continually monitor the health of our process. As a batch progresses from one stage to the next, we have to scrutinize hundreds of...
Maturity model
Features
AI Maturity Model for GxP Application: A Foundation for AI Validation
Artificial intelligence (AI) has become one of the supporting pillars for digitalization in many areas of the business world. The pharmaceutical industry and its GxP-regulated areas also want to use AI in a beneficial way. Several pharmaceutical companies are currently running digital pilots, but...
GAMP® Considerations When Relying on Open-Source Software
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GAMP® Considerations When Relying on Open-Source Software
This article aims to refresh information on open-source software (OSS) within regulated computerized systems that was first discussed in an article in May-June 2010 Pharmaceutical Engineering®. The adoption of OSS advanced since then, and the article explores the importance of recognizing when an...
Client Story: Digitizing Validation Globally
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Client Story: Digitizing Validation Globally
Digitizing Validation globally Executing on its visionary Global Quality Management Systems Strategy, industry leaders Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA (MSD) selected Kneat to digitize seven validation work processes at twenty-seven sites across two...
The Building Blocks of DCT
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The Building Blocks of DCT
How to Create a Seamless Experience Across eConsent, eCOA & More Over the past year, the Clinical Trials Enterprise (CTE) made tremendous progress digitizing and decentralizing various elements of the participant and site experience. As COVID continued to spread, sponsors rapidly digitized a number...
Figure 1: The 4 Ps of the pharmaceutical value chain are interconnected. Each element finds its virtual representation in a digital twin (figure © Zeta).
Features
Driving Biopharma Solutions with Digital Technologies
Developing comprehensive digital solutions is crucial for the entire value creation process for pharmaceuticals. A holistic view of the interrelations of product, production process, and plant is becoming increasingly significant. In this context, the application of model-based technologies...
AI’s Promise for ATMPS - C0ver Image
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AI’s Promise for ATMPS
Industry 4.0 applications in biopharma involve the complete spectrum of data science throughout the entire product life cycle of many disparate entity types. Tools such as digitalization, modern data science, and the industrial internet of things (IIoT) exist now, and examples from other industries...
Effect of Industry 4.0 enablers on the product life cycle.
Features
Data Science for Pharma 4.0™: Drug Development, & Production—Part 2
This second of a two-part series explores digital transformation and digitalization in the biopharmaceutical industry with information about how data science enables digitalization along the product life cycle. (Part 1 was published in the March-April 2021 issue of Pharmaceutical...
Functional interface overview.
Features
Cloud Computing Implications for Manufacturing Execution Systems
Cloud computing can be described as networked access and utilization of configurable computing resources such as data and information storage, processing capabilities, applications, and other services on computerized systems provided and/or maintained by a remote organization. As life sciences...
Best Practices for Deploying Real-World Evidence Solutions
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Best Practices for Deploying Real-World Evidence Solutions
Real-world evidence (RWE) is clinical evidence regarding the usage and potential benefits or risks of a medical product derived from analysis of real-world data (RWD) relating to patient health status and the healthcare delivery.US Food and Drug Administration. “Use of Real-World Evidence to...
IT Services: Applying Good IT Practice & Automation
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IT Services: Applying Good IT Practice & Automation
This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure. It covers recommendations made by a US FDA/industry team linked to the US FDA Center for Devices and Radiological Health (CDRH) Case for Quality initiativeUS Food and Drug Administration Center for Devices...
Industry 4.0 & the Future of the Pharmaceutical Industry
Online Exclusives
Industry 4.0 & the Future of the Pharmaceutical Industry
Industry 4.0 is the recent movement toward intelligent automation technology. In this new era, the integration of modern manufacturing skills and novel information technologies plays an important role on economic competitiveness.Zawadzki, P., and K. Żywicki. “Smart Product Design and Production...
ISPE Pharma 4.0™ SIG & Its Working Groups
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ISPE Pharma 4.0™ SIG & Its Working Groups
The ISPE Pharma 4.0™ Special Interest Group (SIG) launched in 2015 to provide a road map for new challenges of digitalization, Industry 4.0, and the smart factory. The Special Interest Group addresses how pharmaceutical industry stakeholders, including regulatory authorities, can achieve benefits...
The holistic supply chain
Features
Holistic Control Strategy: From ICH Quality Guidelines to Pharma 4.0™
The fourth Industrial Revolution (also known as Industry 4.0) is the era of smart machines, storage systems, and production plants that can autonomously exchange information, trigger actions, and control operations free of any human intervention. To ensure future success in the delivery of...
Empathy phase elements identified in the workshop
Features
"How to Pitch and Shape a Pharma 4.0™ Project” Workshop
During the ISPE Pharma 4.0™ Virtual Conference, the Management Communication working group of the ISPE Pharma 4.0™ Special Interest Group (SIG) held a workshop to support ISPE members in pitching, shaping, and presenting a Pharma 4.0™ project/program to company management.
Data and analytics architecture at Eli Lilly and Company used with permission from D. Sternasty, Eli Lilly and Company).
Features
2020 ISPE Pharma 4.0™ Virtual Conference Highlights
Through this difficult time of the COVID-19 pandemic, ISPE has remained active. At the 2020 ISPE Pharma 4.0™ Virtual Conference, 17–18 November, 174 attendees gathered online to discuss and learn about the progress of the pharma-specific industry 4.0 approach, Pharma 4.0™ (now a registered...
Emerging Leaders Editorial John Clarke Banner
Insights
Emerging Leaders Editorial: Pharma 4.0™ - The Pillars for Success
Understanding and utilization of Pharma 4.0™ technologies will be critical for students and Emerging Leaders (ELs) as they develop in their careers in the pharmaceutical and life sciences industries. To learn more, I spoke with Edoardo Schiraldi, an Emerging Leader based in Florence, Italy, who...
Figure 1: Examples of graphs generated from PEEM-DB.
Features
A New Pharmaceutical Equipment Exposure Measurement Database
This article describes the Pharmaceutical Equipment Exposure Measurement Database (PEEM-DB), which was launched in July 2019 by the ISPE Japan Affiliate for its members. PEEM-DB is offered as a tool for rationally advancing optimal containment equipment settings by collecting exposure measurement...
Figure 1: CNN model training process and validation results for a lyophilized vial AVI system.
Features
Vision Inspection Using Machine Learning/Artificial Intelligence
Pharmaceutical companies rely on automated vision inspection (AVI) systems to help ensure product safety. Although these systems overcome challenges associated with manual inspection, they can be hindered by limitations in their programming—if the system is programmed to consider every variation in...
Technology Trends: The Transition to Digitalization
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Technology Trends: The Transition to Digitalization
In the pharmaceutical industry, digitalization involves developing and implementing digital technologies at all levels of pharmaceutical operations. The aim is to transform the industry by capturing, analyzing, and using vast amounts of data collected from a wide range of sources to support...
The Untapped Potential of AI &  Automation in Pharmacovigilance
The Untapped Potential of AI &  Automation in Pharmacovigilance
Between 2009 and 2019, the number of adverse events (AEs) for drugs and therapeutic biologic products recorded by the US FDA Adverse Event Reporting System (FAERS) increased more than 300%, from 490,032 to 2.19 million cases (as of 31 December 2019).US Food and Drug Administration. “FDA Adverse...
Generic information fl ow for digital design of manufacturing process
Technical
A Systems-Based Approach to Digital Design & Operation
The Advanced Digital Design of Pharmaceutical Therapeutics (ADDoPT) project“ADDoPT—Advanced Digital Design Transforming Pharmaceutical Development and Manufacture.” Accessed 1 September 2019. https://www.addopt.org is a recently completed UK-based design manufacture and supply chain research...
RIP Spreadsheets and Fishbones
iSpeak Blog
RIP Spreadsheets and Fishbones: Their Time Has Come and Gone
You are sitting with a group of people around a table in a conference room. On the wall, a monitor displays a spreadsheet showing the inputs and outputs of a complex manufacturing process in a vast matrix. The purpose of the meeting is to assign risk...
Application of SOC 2+ Process to Assessment of GxP Suppliers of Services
Features
Application of SOC 2+ Process to Assessment of GxP Suppliers of Services
To facilitate the assessment and mitigation of compliance risks associated with a third-party service organization, its services, and the systems used to provide the services, this article proposes adopting an approach from the financial sector that, with a little modification, could be used to...
Article
Technical
Blockchain for Pharmaceutical Engineers
This article discusses how blockchain technology may disrupt the way we collect and manage data within regulated processes. The first section is a nontechnical summary of blockchain’s features, including a description of what it is (and what it is not). This sets the context for the next section,...
Data Integrity: A Vertical Journey Banner
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Data Integrity: A Vertical Journey
Data is an important factor that is reshaping the pharmaceutical industry and triggering significant innovation. Vertical integration of equipment can represent an optimal solution to manage the increasing flow of data efficiently, innovate the manufacturing environment, and fulfill data integrity...
Data Integrity: Beyond the Lab Banner
Features
Data Integrity: Beyond the Lab
The 2018 ISPE Quality Manufacturing Conference, held 4–6 June 2018 in Arlington, Virginia, included a well-attended session entitled “Data Integrity—Beyond the Lab,” which reaffirmed continued focus from both industry and regulators on this critical element of assuring product quality and patient...
Data Integrity in the Trenches: A Look into Quality Control Lab
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Data Integrity in the Trenches: A Look into Quality Control Lab
Pharmaceutical Engineering magazine’s March–April 2016 Special ReportInternational Society for Pharmaceutical Engineering. “Special Report: Data Integrity.” Pharmaceutical Engineering 36, no. 2 (March–April 2016): 39–67. highlighted the increasing importance of data integrity for companies...
Data
Technical
Getting Ready for Pharma 4.0™
The amount of data collected in a typical pharmaceutical manufacturing operation is staggering, yet research shows that much of this information is rarely used for anything more than compliance. New technologies such as big data, artificial intelligence, machine learning, and deep learning permit...
ISPE Pharmaceutical Engineering
Special Reports
Lessons Learned from the Sarbanes-Oxley Act
Fifteen years ago, corporations embarked on a journey toward SOX compliance; along the way they have learned a tremendous amount about data integrity as it relates to financial systems. Those lessons learned are directly applicable to many of the data-integrity challenges facing the pharmaceutical...
Data Integrity & Biopharmaceutical Manufacturing
Special Reports
Special Report: Data Integrity & Biopharmaceutical Manufacturing
Before the advent of integrated computer systems, LIMs, HMI interfaces, comprehensive software, CGMP, BAS, process control systems, PAT, and the use of statistics, manual record keeping was fraught with errors—most of them unintentional. This led to...