Categorization offers a useful starting point for assessing the risk of failure for individual software components, but it is not a validation checklist. Organizations must apply critical thinking to combine categorization with risk assessment and supplier assessments to appropriately scale life cycle activities and manage risk.

This article presents a model for promoting data quality of real-world data and evidence (RWD/RWE) and GxP processes with references to ISO 8000 for data quality management, making it a common language between regulated and nonregulated organizations.

Data integrity drives quality and compliance. Content addressable storage (CAS) stores and retrieves files by content type—not file location—using cryptographic fingerprints. The result: a mathematically provable version control, without broken links and far fewer audit headaches.

A single global digital chemistry, manufacturing, and controls (CMC) dossier is rapidly transitioning from a bold vision to a practical reality. However, realizing the full potential of these innovations requires significant coordination to harmonize and align across initiatives.

To accelerate the adoption of innovation in the global administration of the pharmaceutical industry, regulatory authorities and industry trade organizations must expand their scope and pursue a collaborative approach to recognition and reliance to streamline processes, enhance product quality, and improve patient access to medicines.

Thanabalan “Thana” Subramanian is Head of the Digital Quality team in the quality, regulatory, digital consultancy firm Product Life Group. He is responsible for a team of 20 consultants and supports the Digital Quality Center of Excellence, covering IT compliance, computer software validation (CSV), data integrity, CSV auditing, and CSV training. Before joining Integrity, he worked for...

Frank Henrichmann is an expert in quality management, computerized system validation, and compliance, especially in clinical trials and pharmacovigilance. With over 25 years of experience in quality functions within the pharmaceutical industry, he has gained deep expertise in implementing and validating computerized systems within GxP-regulated environments, having worked with organizations...

The 2025 ISPE D/A/CH workshop on “Pharma’s Journey to Digital Manufacturing and Supply” united pharma leaders, technology experts, and regulatory authorities for three days of intense exchange on the digital transformation of our industry.

Sustainability principles can be effectively integrated into commissioning and qualification (C&Q) projects to support environmental goals without compromising compliance, quality, or patient safety. By positioning C&Q as both a verification tool and an enabler of sustainable intent, this article outlines a practical path for the pharmaceutical sector to enhance operational efficiency,...

The pharmaceutical industry’s embrace of digital technologies and sustainability is no longer a competitive advantage, but an operational necessity. As Pharma 4.0™ matures, its integration will be vital for achieving net-zero objectives and achieving pharmaceutical excellence.

Crafting a sustainable packaging strategy for the pharmaceutical industry is complex and requires balancing environmental responsibility with regulatory compliance and operational costs. In this article, we explore the key drivers, challenges, and best practices for developing such a strategy.

The development of platform drug delivery devices for combination products offers a transformative approach to drug delivery by enabling the reuse of device data across multiple drug and device combinations.

Advancements in technology—such as process intensification, continuous manufacturing, and 3D printing—are enabling transportable and point-of-care (PoC) medicines manufacturing, especially with the rise of personalized medicine. Modular, small-scale production systems are particularly well-suited for cell and gene therapies and other advanced therapy medicinal products (ATMPs) designed for...

In April 2023, ISPE launched a survey to understand the sources of barriers to technological innovation within the pharmaceutical industry. This survey is part of an expansive and significant initiative by ISPE, Enabling Global Pharma Innovation: Delivering for Patients, which aims to promote consistent and harmonized interpretation and implementation of guidelines issued by the International...

Defining requirements for calibration and routine testing of weighing equipment in the laboratory and production remains a complex endeavor for pharmaceutical companies. Applying sound, risk-based metrological strategies across the entire pharmaceutical value chain will help manufacturers ensure compliance, consumer safety, and commercial success.

The United States Pharmacopeia (USP) Packaging and Distribution Expert Committee approved chapters 665 and 1665 in 2024. These chapters establish clear and general guidelines for the use of plastic materials in process equipment used within the pharmaceutical and biotechnology industries. Their publication has raised new questions regarding the role of polymeric materials in manufacturing...

The increasing digitalization of the pharmaceutical and medical device industry has created novel cybersecurity challenges, particularly with the rapid advancement of artificial intelligence (AI) technologies. This article examines the dual nature of AI as both a potential threat vector and a powerful defensive tool.

The move to digital transformation represents a true paradigm shift in manufacturing, enabling organizations to leverage advanced technologies such as the Industrial Internet of Things (IIoT), cloud computing, and artificial intelligence (AI) to ensure compliance and secure a competitive advantage. This article presents a working definition of digital transformation, the components involved in...