ValGenesis Resources

Artificial intelligence (AI) is quickly becoming one of the most aggressively marketed technologies in validation and quality operations. Nearly every validation software provider now claims to offer AI-enabled ...

A batch is complete. The equipment is empty, and cleaning has been scheduled. Then another changeover takes priority, the cleaning crew is reassigned, and several hours pass. No deviation has occurred. No alarm has ...

Commissioning, qualification, and validation (CQV) are essential to ensuring that facilities, utilities, equipment, processes, and computerized systems are fit for their intended use. Together, these activities provide ...

Artificial intelligence (AI) is becoming a defining topic across validation and quality operations. Every major software provider now claims to offer AI-enabled capabilities, and most organizations are actively ...

A qualification package shouldn't come together at the end of a project. It should take shape throughout the project. Yet many validation teams spend considerable time rebuilding documentation before qualification ...

Tech transfer is where process knowledge is tested under real-world conditions. As products move from development to manufacturing—or across sites and partners—teams must transfer complex process understanding without ...

Cleaning validation usually gets funded the same way investigations get staffed: when something goes wrong. A deviation occurs, a residue result doesn’t match expectations, or a batch is placed on hold. Suddenly, work ...

Post-approval changes remain one of the most challenging areas in pharmaceutical manufacturing. Global reporting requirements vary, change pathways are not always clear, and organizations must balance regulatory ...

Artificial intelligence (AI) is rapidly advancing in validation, CQV, and quality operations across life sciences, but many organizations are still trying to separate meaningful transformation from AI hype. While many ...

Kneat recently published an article on its website titled "8 best ValGenesis alternatives." Based on ValGenesis’ review of the article, it is a vendor-authored comparison that ranks Kneat as the best alternative to ...

Validation teams are being asked to scale CQV work in environments that are getting harder to manage: compressed timelines, more frequent change, multisite deployments, and increasingly interconnected manufacturing ...

Quality by Design (QbD) gives CMC teams a structured way to define product goals, identify the attributes and parameters that matter most, and build controls around them across development and manufacturing. But as ...

Cleaning validation limits were designed to reduce risk by controlling carryover and protecting both patient safety and product quality. But as product portfolios become more potent, shared equipment strategies become ...

Knowledge management (KM) in pharma goes beyond storing files. It requires a connected approach that brings together tacit and explicit knowledge, unifies structured and unstructured data, and makes that information ...

When a program reaches a late stage of development, teams should not only be able to demonstrate process understanding but also make that knowledge readily available. By the time a product is approaching tech transfer, ...

Analytical Quality by Design (AQbD) provides development teams with a structured way to define method goals, understand method performance, and manage change over time. But as teams begin applying AQbD principles, ...

Across life sciences, there is a growing assumption that regulatory scrutiny of artificial intelligence (AI) will focus primarily on technical models and algorithms. In practice, that is not where inspections begin. ...

In cleaning validation, a change impact assessment is where change control becomes actionable. It’s the structured evaluation that takes a change in the cleaning program and maps it to the cleaning validation elements ...

Across pharma and biopharma, teams often assume QbD initiatives stall during development. While that does happen, the real breakdown often appears after approval, when the consequences of a weak QbD approach become ...

Continued process verification (CPV) is widely recognized as a cornerstone of lifecycle process validation. In many organizations, however, it is still performed primarily as a retrospective reporting exercise rather ...

Risk management forms the foundation of medical device safety and compliance. It is a structured and systematic approach to identifying, evaluating, controlling and monitoring risks throughout the lifecycle of a medical ...

Spreadsheets have become the default tool for Quality by Design (QbD). They are familiar, easy to access, and flexible enough to support a wide range of development activities. Teams use them to evaluate risk, assess ...

Commissioning, qualification, and validation (CQV) remain foundational to pharmaceutical manufacturing, ensuring that facilities, equipment, utilities, processes, and computerized systems operate as intended. For ...

Despite broader advances in digitalization across qualification and validation lifecycles, cleaning validation frequently remains dependent on spreadsheets, PDFs, and manual workflows. It is often seen as a “necessary ...

Continued Process Verification (CPV) was never meant to be a “check-in-a-box" exercise. At its best, CPV is a living confirmation that a process remains in its validated state of control, through every production batch ...

In the data-driven world of life sciences, quick and reliable access to accurate data is essential. Yet many companies still rely on physical logbooks that require storage, upkeep, and painstaking manual retrieval. ...

The delay usually looks minor on the schedule. A cleaning validation report is still “with QA,” a protocol is “waiting on one signature,” and lab results are “almost ready.” Production reshuffles a few batches, and ...

Quality by Design (QbD) is the dominant framework for robust, science- and risk-based process development in the (bio)pharmaceutical industry, especially in an era where product pipelines are more complex, modalities ...

Commissioning, qualification, and validation (CQV) have always been the guardians of product quality and patient safety. Yet as life sciences organizations accelerate toward digital maturity, traditional methods built ...

For an industry defined by precision and scientific progress, validation in life sciences remains surprisingly manual. Too many organizations still rely on paper-on-glass (PoG) methods — spreadsheets, PDFs, and ...

In Part 1 of this series, we examined why cleaning validation continues to be a leading source of FDA findings and compliance risk. In Part 2, we explored how regulators are driving the industry toward risk-based, ...

In part 1 of this series, we explored why cleaning validation continues to top FDA inspection findings and why traditional compliance-only approaches often fall short. In part 2, we’ll examine the building blocks of a ...

Introduction to The Future of Cleaning Validation Series Cleaning validation has been a focus of discussion among industry experts and regulators since the FDA introduced 21 CFR Parts 210 and 211 in 1978, emphasizing ...

Binders feel safe. But in commissioning, qualification, and validation (CQV), they create context gaps, transcription errors, slow retrieval, and audit pressure when regulators, inspectors, or QA reviewers demand ...

On Sept. 16, 2025, more than 150 life sciences leaders gathered in Princeton, New Jersey, for the inaugural ValGenesis ValConnect Innovation Day — U.S. Edition. Against the backdrop of one of the world’s most dynamic ...

In the pharmaceutical manufacturing industry, maintaining high standards of cleanliness is not just a best practice but a regulatory necessity. If you’ve ever wondered why cleaning validation is required, the answer is ...

When people first ask, “What is CMC in pharma?” the answer seems simple: Chemistry, Manufacturing, and Controls (CMC) is the discipline that ensures new drugs are consistently safe, effective, and high quality. In ...

Audit readiness comes from how you run commissioning, qualification and validation (CQV) every day. With a risk-based approach, you focus effort on the activities that most affect patient and product quality. A digital ...

An FDA Form 483 for inadequate cleaning validation can halt production, trigger costly remediation, and tarnish a brand overnight. In today’s regulatory landscape, what qualifies as cleaning validation in pharma has ...

In the race to bring new therapies to market, few processes are more critical than technology transfer. Whether scaling a product from development to manufacturing or transferring it between sites, successful tech ...

The process of commissioning, qualification, and validation (CQV) sits on the critical path between a promising production line and commercial supply. Yet even in 2025, many life sciences companies still rely on binders ...

Validation plays a foundational role in ensuring the safety, quality, and compliance of pharmaceutical and biopharmaceutical products. However, many organizations still rely on fragmented systems to manage their ...

Editor’s note: This blog post summarizes key insights from an article originally published in Quality Digest on March 12, 2025. As pharmaceutical manufacturers race to innovate, one group of facilities often finds ...

Despite being a long-standing requirement in regulated manufacturing, cleaning validation continues to challenge even the most mature organizations. Manual workflows, disconnected data, and reactive documentation make ...

Quality by Design in pharma is widely recognized as the modern framework for drug development. By systematically defining product and process parameters, conducting risk assessments, and applying experimental data, QbD ...

Are you still buried in piles of paper during validation projects? Do you find yourself chasing signatures and scanning binders instead of focusing on the science behind drug manufacturing? If so, it’s time to rethink ...

Commissioning, Qualification, and Validation (CQV) form the backbone of pharmaceutical and biotech manufacturing. These processes confirm that your facilities, equipment, and operations consistently meet regulatory ...

Efficiency and compliance are critical in life sciences, yet outdated paper-based validation processes put both at risk. MilliporeSigma, the life sciences division of Merck KGaA in the U.S. and Canada, needed a faster, ...

The requirements traceability matrix (RTM) plays a critical role in validation within the life sciences. It links requirements to their corresponding test protocols, ensuring your team effectively verifies all system ...

In the life sciences sector, regulatory expectations and operational complexities are constantly evolving. To stay ahead, organizations must continuously reassess their validation processes and digital tools. Doing so ...

Change doesn’t come easily in life sciences, where scientific rigor guides research, development, and compliance. Strict regulatory requirements, risk aversion, and the high stakes of ensuring patient safety often slow ...

Computer software assurance (CSA), the FDA’s updated framework for computer system validation (CSV), is a significant step forward. While its promise of simplified, cost-effective validation is compelling, many life ...

Compliance underpins operational integrity in regulated industries like pharmaceutical manufacturing. Adhering to stringent cleaning validation requirements set by global regulatory agencies ensures the safety, quality, ...

In life sciences manufacturing, maintaining compliance with FDA regulations is a fundamental pillar of your business. Yet, despite the industry's rigorous nature, FDA Form 483 observations remain a common and costly ...

The life sciences industry relies on rigorous processes to ensure compliance, safety, and quality in both software and operational validation. Traditionally, validation professionals have used the Waterfall methodology ...

The life sciences industry operates in a high–stakes environment, where precision, compliance, and efficiency are critical. For organizations managing the complexities of validation, the need to optimize processes while ...

In pharmaceutical manufacturing, cleaning validation is the cornerstone of product quality and patient safety. Proper cleaning validation guidelines help prevent contamination, reduce cross-product risks, and ensure the ...

Editor’s Note: The following blog post summarizes an article written by ValGenesis Senior Industry Consultant Chinmoy Roy, published September 19, 2024, on PharmTech.com.

Control strategies are the backbone of product quality in the pharmaceutical industry, especially as regulatory expectations intensify. To remain compliant, efficient, and consistent, many manufacturers are turning to ...

In the life sciences, commissioning, qualification, and validation (CQV) ensure that equipment, facilities, and systems perform as expected, meet regulations, and keep product quality and patient safety in check. ...

A Multi-Site Digital Continued Process Verification (CPV) system allows you to manage and monitor manufacturing processes across multiple sites in real-time. For pharmaceutical companies, this system offers a ...

In the fast-paced world of pharmaceutical manufacturing, product quality and patient safety are paramount. Many facilities produce multiple drugs using shared equipment, so effective cleaning between product changeovers ...

In September 2022, the FDA issued its draft guidance for computer software assurance (CSA), marking a significant shift from traditional computer system validation (CSV) to a more quality-driven approach. This guidance ...

In the highly regulated world of life sciences, organizations must adhere to guidelines such as the FDA’s Draft Guidance for Computer Software Assurance (CSA), ICH-Q9, and GAMP 5. Consequently, there is a constant drive ...

In pharmaceutical manufacturing, every process and step must be precise, particularly when handling and cleaning manufacturing equipment. Clean hold time (CHT) and dirty hold time (DHT) are critical aspects of ...

Biopharmaceutical industries are under constant pressure to ensure the highest quality standards during manufacturing while also maximizing efficiency and controlling costs. Continued Process Verification (CPV) plays a ...

One of the most critical aspects of the evolution of pharmaceutical manufacturing is the digitalization of control strategies. Embracing the digital transformation of control strategies allows companies to enhance ...

In the highly regulated world of pharmaceutical manufacturing, compliance with FDA guidelines is not just a legal requirement, it's a critical component of ensuring patient safety and product efficacy. One area that ...

In today’s fast-paced software development environment, Agile methodologies have become the gold standard. Agile has revolutionized how software is built, particularly in industries where speed and adaptability are ...

In a recent blog post, Better Tech Transfers: A Digital Transformation Approach, we explored the strategies contract development and manufacturing organizations (CDMOs) are adopting to enhance their operations. In this ...

The pharmaceutical industry is undergoing a transformative shift driven by the integration of data systems with digital technologies. As companies strive to streamline processes and enhance product quality, adopting ...

The FDA's computer software assurance (CSA) guidance has garnered significant attention but also introduced many misconceptions. This blog post aims to debunk the top five myths about CSA, offering clear insights to ...

The pharmaceutical industry is undergoing a significant transformation with the advent of digital technologies and Pharma 4.0 principles. This blog post explores the challenges associated with commissioning and ...

Product Quality Review (PQR) is a key aspect of pharmaceutical and biopharmaceutical manufacturing, ensuring product quality and regulatory compliance. Despite its importance, creating a PQR is often full of ...

Editor’s note: This blog post summarizes a comprehensive case study about Transcat's successful implementation of ValGenesis VLMS to enhance their equipment qualification process. Please click the link at the end of ...

Maintaining high standards of quality is crucial to ensure regulatory compliance and, consequently, patient safety. The International Council for Harmonisation (ICH) plays a pivotal role in setting these standards, ...

From June 17 through June 19, Lisbon, Portugal, played host to ValConnect 2024, the annual ValGenesis user conference. This international event brought together a diverse mix of customers, industry experts, ValGenesis ...

While the benefits of the FDA’s computer software assurance (CSA) methodology are clear, many medical device manufacturers and biopharmaceutical companies hesitate to adopt it due to ingrained habits and a fear of the ...

The discovery and development of new drugs, at present, remains a lengthy and highly expensive endeavor. Typically, it takes between 10 to 15 years of research and testing to bring a new drug to market. The vast number ...

For more than 20 years, ValGenesis has been at the forefront of digital validation lifecycle management solutions. Our flagship VLMS platform, the first-ever to secure a patent for paperless validation, established ...

Quality by Design (QbD) is a cornerstone of modern pharmaceutical process development and chemistry, manufacturing, and controls (CMC) data management. As a framework, QbD emphasizes a systematic and proactive approach ...

In the highly regulated world of pharmaceutical manufacturing, operational efficiency is paramount. Every minute wasted and every error made can impact product quality, regulatory compliance, and ultimately, patient ...

Editor’s Note: The following blog post summarizes an article that initially appeared in Quality Digest magazine on April 11, 2024. Risk assessment and continued process verification (CPV) are fundamental regulatory ...

One transformative approach making significant inroads across pharmaceutical and biopharmaceutical manufacturing is real-time monitoring (RTM). RTM technology's increasing popularity stems from its ability to allow ...

Central to product safety and efficacy is the rigorous process of cleaning validation, which involves assessing and documenting the effectiveness of cleaning procedures to prevent cross-contamination and ensure product ...

The annual product quality review (APQR) is one of the most important yearly evaluations of a pharmaceutical product’s quality, ensuring manufacturing consistency and identifying potential process improvements. But more ...

Transitioning from paper to electronic logbooks (aka e-logbooks or elogs) is imperative for organizations seeking to streamline operations and maintain compliance. Central to the effectiveness of any elog software ...

Computerized systems used in production and the quality management system need assurance proportional to their intended use and risk. This post explains how ISPE's GAMP 5 (Second Edition) and the FDA's Computer Software ...

Microsoft Excel remains the predominant tool for risk management across the life sciences industry. Spreadsheets are inherently limited, but their adaptability, user-friendly interface, and cost-effectiveness have ...

This post is the second installment of a two-part series on best practices for an integrated commissioning and qualification (C&Q) approach. The first installment examined phases one (Requirement) and two (Design), ...

In this two-part blog series, we delve into the critical realm of commissioning and qualification (C&Q) in life sciences. We begin with the rationale behind C&Q. Then, we outline a risk-based framework for ...

In previous posts, I've outlined the benefits of using electronic logbook software (also called e-logbook software) to document equipment-related activities such as cleaning, calibration maintenance, usage, and repairs. ...

Transitioning from traditional paper logbooks to modern digital logbooks opens up a world of advantages for life sciences organizations, such as increased efficiency, accuracy, compliance, and collaboration. In this ...

In the dynamic landscape of pharmaceutical manufacturing, a digitized ecosystem is instrumental in optimizing technology transfer processes. In this blog post, we will delve into the rising costs of drug development, ...

If computer software assurance is the next evolution in validation, why haven't more companies abandoned traditional computer system validation (CSV) and adopted a full CSA approach? This question has been on the minds ...

Commissioning and qualification are interrelated processes that ensure facilities, utilities, equipment, and systems used throughout pharmaceutical manufacturing fit their intended purpose. This blog post provides a ...

Quality risk management (QRM) within vaccine development is extremely important, as it plays a key role in ensuring the safety and effectiveness of the final product. This blog post intends to share the narrative of a ...

The concept of process validation has been evolving since 1978 when the FDA issued “good manufacturing practice (GMP) regulations.” In the field of pharmaceutical manufacturing, process validation aims for excellence in ...

Cleaning validation plays a crucial role in the pharmaceutical and biopharmaceutical industries by ensuring that equipment and facilities are thoroughly cleaned to prevent any potential cross-contamination. It is a ...

Editor’s Note: The following blog post summarizes an article that initially appeared in PDA Letter magazine. Read the full article. Life sciences companies need trustworthy data to ensure the safety and quality of their ...

Editor’s Note: The following blog post summarizes an article that originally appeared in Pharma Manufacturing Magazine (September 19, 2023). Equipment qualification is an important process in modern-day life sciences ...

Effective risk management is crucial for life sciences manufacturers to ensure the safety, quality, and compliance of their products and patients. A robust risk management process not only safeguards against potential ...

A Structured Framework for Successful ICH Q12 Adoption In the ever-evolving landscape of pharmaceutical manufacturing, the implementation of ICH Q12 presents a significant opportunity for companies to enhance their ...

Various types of validation are required throughout the drug product development and manufacturing lifecycle. In this post, we'll explore the key types of validation in the pharmaceutical industry.

Following ALCOA data integrity principles helps pharmaceutical companies maintain reliable data. This is especially important as regulatory requirements continue to increase and digital systems become more significant. ...

If you work in any sector of the life sciences industry, you know how important it is to comply with 21 CFR Part 11, the part of Title 21 of the Code of Federal Regulations that sets the standards for ensuring the ...

In the strict pharmaceutical and life sciences industry, keeping detailed records is a regulatory requirement. Accurate and clear documentation of processes is crucial for product quality, patient safety, and regulatory ...

Paper-based validation is prone to human error. It slows production efficiency, increases compliance risk, and delays time to market—costing regulated companies tens of millions of dollars annually. Companies that rely ...

Handling post-approval changes (PACs) can be challenging. There are different timelines and submission rules, and on top of that, optimizing your processes can be difficult. That's why having a clear post-approval ...

One of ValGenesis specialities is the digitalization of the Continued Verification Process (CPV).

This post is the second installment of a two-part series on the potential impact of generative AI, particularly ChatGPT, on validation in the life sciences. The first installment examined the differences between ...

There is an enormous amount of information about Artificial Intelligence (AI), Machine Learning (ML), and generative AI tools like ChatGPT, a language model-based chatbot launched in November 2022 by OpenAI. The sheer ...

In a world dominated by rapid technological advancements, the pharmaceutical industry faces an ongoing struggle to adapt traditional risk assessment practices to the evolving complexity of operations and technologies.

When it comes to testing, the key distinction between computer system validation (CSV) and computer software assurance (CSA) lies in their approaches. CSV adopts a thorough "test everything" mindset, while CSA promotes ...

In this blog post we'll discover how ValGenesis Consulting successfully collaborated with a customer to implement a comprehensive developability scoring system using Machine Learning (ML). This project was truly ...

In the fast-paced world of pharmaceuticals, regulatory compliance and maintaining top-notch quality standards are vital. However, the conventional computer system validation (CSV) approach is becoming outdated and ...

Blockchain technology is revolutionizing how data integrity is ensured in clinical trials by offering a transparent and secure way to record and access trial data, increasing trust and compliance.

Integrating process data with risk management can trigger many improvement opportunities and competitive advantages. In this blog post, we’ll look at the three main benefits of doing so, and how this integration can ...

According to FDA 820.3(z), “Validation means confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use can be consistently fulfilled.” Ironically, the ...

As you know, GMP Annex 1 is a guideline developed by the European Medicines Agency (EMA) and the European Commission that provides guidance on manufacturing sterile medicinal products. It includes the manufacturing ...

Any computer system (or automated data processing system) used to automate any part of the quality or production system must be validated for its intended use with an established protocol, as required by the U.S. Food ...

When you scan the GxP domains (good laboratory practice/GLP, good clinical practice/GCP, and good manufacturing practice/GMP) for examples of their use of artificial intelligence/machine learning (AI/ML), you quickly ...

The ICH Q9(R1) guideline on Quality Risk Management (QRM) is on its way to reaching Step 5 of the ICH process around the globe. As you can see, a large part of the world has already implemented it, while the rest plans ...

Applying continued process verification (CPV) plans to continuous production can be challenging due to the large amounts of data it generates and the complex nature of continuous manufacturing. In this blog post, we ...

As an auditor, it raises a big red flag when I discover that a company uses spreadsheets in regulated environments. That's because spreadsheets are hard to control, can easily be misused, and may not adhere to the ...

Cleaning validation remains a significant concern during GMP inspections. The high number of FDA 483 observations and warning letters issued, year after year, for cleaning-related violations is a clear indication that ...

Quality risk management (QRM) is a crucial process for ensuring the safety and efficacy of drugs throughout their lifecycle, from development to commercial manufacturing. By proactively identifying and managing ...

Have you ever added the wrong ingredient to a recipe and spoiled the dish? The same can happen when you are writing requirements. Requirements are a critical part of the requirements management process and the ...

In this blogpost, we will explore the application of Quality By Design (QbD) for Cell & Gene Therapies.

This is a happy story. But it’s also confidential in some parts, which is why we changed names and a few details. But don’t worry, it’s quite faithful to what happened.

The draft guidance on computer software assurance (CSA) is a complete paradigm shift from document-focused computer system validation to critical thinking assurance practices. This isn't nearly as dramatic as it sounds. ...

By now, we all know that Quality by Design (QbD) is essential to deliver safe and effective medicines. Because of that, the Pharma Industry is trying to adapt this methodology to Analytic Methods development. And it’s ...

How ValGenesis VLMS fosters a Quality-Focused Culture This is the third-and-final write-up on FDA’s Computer Software Assurance (CSA) explains how the ValGenesis Validation Lifecycle Management System (VLMS) fosters a ...

The new ICH Q14 introduces the concept of an enhanced approach for the development of an analytical method. In this approach the analytical procedure is well understood and fit for intended purpose, following a Quality ...

Paper-based validation has remained the norm for decades in the pharmaceutical industry – even though it’s an inefficient and inconsistent bottleneck prone to human error. However, a transition to virtual or remote ...

Using a digital validation lifecycle management system (VLMS) can save a company millions of dollars in project costs, increase productivity, and provide a host of other advantages that paper-based validation doesn’t ...

Traditionally, validation focuses on validating something, such as a piece of equipment, a computer system, a process, and so on. It generates a lot of documentation (e.g., VP, IQ, OQ, PQ, RTM). Then the validation ...

As you probably already know, the ICH Q14 guideline proposes science and risk-based approaches for developing and maintaining analytical procedures. To ensure they perform as expected we must have an efficient control ...

Who doesn’t like a good story, especially when it has a happy ending? That’s the case of this ValGenesis story, where we helped a company with their biosimilar product approval.

During the operational phase of Clean In Place (CIP) cycles companies rely in manual methods to determine the success of routine cleaning process. Some of these manual methods to determine the success of the routine ...

When we talk about software, the saying “garbage in garbage out” applies both for data and its requirements. And if you write a poor user requirements specification, the result will be a poor software.

EDITOR’S NOTE: In this first installment of a two-part series, we cover the 12 biggest reasons pharma manufacturers should make the switch from paper-based to digital validation now. Despite the clear disadvantages of ...

Today we want to take a fresh look into comparability for post-approval changes. How? We’re thinking of a unique multiparametric approach. This approach is aligned with the FDA’s tiered and totality-of-evidence concepts ...

This ValGenesis story is about how we helped a company finding a root-cause associated to Filter Clogging. Would you like to know more? Keep reading!

The key to control for any process resides in understanding its variability. How much do we know about the variation of our processes or systems, and are we in a state of control? These questions require answers to ...

Generic products can be safe, effective, and lower cost alternatives to brand name drugs. Therefore, they’re important to reduce healthcare costs and increase the access to medicines. Since the clinical trial data ...

If you’ve been following our posts on continued process verification (CPV), you already know it plays a critical role in maintaining product quality across the pharmaceutical lifecycle. We’ve explored how to implement ...

In traditional Computer System Validation (CSV), assurance needs sit near the bottom of the hierarchy. CSV prioritizes documentation first, followed by testing, assurance needs, and finally critical thinking. However, ...

Life sciences companies are under increasing pressure to use advanced manufacturing processes and sciences to ensure that manufactured drugs and devices meet patient safety, product quality, and data integrity ...

Recently, the FDA issued the draft of a new guidance for Computer Software Assurance (CSA) for computers and automated data processing systems. The goal? To describe how can CSA simplify your Validation process.

Who doesn’t like a good story? Well, we have another for you!

This is the fourth post in a series of five summarizing a podcast series devoted to CSA. You can find the complete series here.

Subjectivity in Risk Assessments and Quality Risk Management (QRM) outputs has been under the spotlight recently. In this post we will explore why, how, and what are the tools that you can use to minimize it.

It seems like everyone is talking about computer software assurance these days, including the FDA. The Agency's upcoming CSA guidance, Computer Software Assurance for Manufacturing, Operations and Quality System ...

During biopharma process development, there are often process changes that occur between non-clinical and clinical phases. When it comes to early development stages, Comparability Studies can be challenging.

Leveraging Technology to Address the ALARP vs AFAP Challenge It is a regulatory requirement for Medical Device companies to perform Risk Management and provide documented evidence to demonstrate compliance with ...

Q: What is Hands-Free Validation? A: Hands-free validation is the ability to perform validation tasks with no- or low- touch. In some instances, 100% paperless hands-free validation is possible and, in fact, ...

The International Council for Harmonisation (ICH) released a draft of the new ICH Q14 Guideline last March. This is the first guideline on analytical procedure development and it’s generating a lot of interest since it ...

In the life sciences industry, commissioning and qualification (C & Q) are critical processes associated with the manufacturing of pharmaceutical and biotechnology products.

Changes are challenging, and in the digital world what we see the most are changes due to the continuous development of new technologies and concepts. Let’s look back at the Computer System Validation (CSV) history. ...

Digital transformation isn’t all about technology. To succeed in your Pharma 4.0 journey, you must devise a strategy to engage and excite your most important asset — people. Here are some tips for getting your employees ...

During and after the COVID-19 pandemic, prevailing chaos in geopolitical and financial systems, sourcing materials, and maintaining the reliability of supply chains needed to sustain life has been increasingly ...

The second stage of the validation lifecycle is called Process Qualification. This stage is customary and is referred to as Cleaning Validation. Usually, three consecutive successful runs are performed to qualify the ...

This blog is the first of a three-part series focused on FDA’s Computer Software Assurance (CSA). It explains how to accelerate CSA adoption within your organization.

Learn how we helped a customer find the root cause of a problem in monoclonal antibody (mAB) production and become stronger.

Equipment qualification and validation (EQ/V) has always been a highly scrutinized subject in life sciences companies, especially during regulatory inspections and audits.

Editor's note: This is the second post in a series of five covering CSA. You can find them all here.

Today, the pharmaceutical industry is facing a lot of pressure to meet the high demands of the customers and regulators. The market is rapidly changing and, as such, your product development needs to keep up with it. ...

Editor's note: This is the final post in a series of five summarizing a podcast series devoted to CSA. Links to previous posts are listed below.

Increasingly complex regulatory challenges in the pharma and biotech industry are forcing companies to go paperless and adopt an end-to-end digital approach in their manufacturing process. While digital validation and ...

Changing Compliance-Centric Mindsets This blog is the second of a three-part series focused on FDA’s Computer Software Assurance (CSA) initiative. If you didn’t get a chance to read the first write-up on how to ...

If you’ve had your finger anywhere near the regulatory pulse, then you know data integrity is on the regulatory radar. While some individuals utilize statistical analysis to detect any irregularities in the data, others ...

Editor's Note: This blog post was reviewed and updated on January 30, 2023.

An important, and sometimes challenging, step in every product lifecycle is the point when it gets its premarket or a postmarket regulatory approval by a regulator. Luckily, through a combination of good practices for ...

The most recent publication of ISPE Good Practice Guide on Knowledge Management (KM) brought once more to the attention the need to have the best practices established when it comes to KM Framework implementation.

The Internet of Things (IoT), sometimes described as an interconnected enterprise system, continues to generate buzz in business circles. By connecting data, information, and knowledge, IoT offers organizations the ...

This is a happy story about Risk Management and Process Optimization. But it’s also confidential in some parts, which is why we changed names and locations. But don’t worry, we didn’t change any details.

This is a successful story about the application of the Quality by Design (QbD) framework in the development of a drug product. However, this time we’re not alone, as this was a joint project with Libbs Farmacêutica!

Making Post-Approval Changes can be a challenge. You have different timelines, different submission requirements and trouble optimizing your processes. Because of that, this makes the knowledge of creating a ...

A well-designed and robust continued process verification (CPV) program delivers more than compliance — it enables real-time visibility into product quality, strengthens your control strategy, and continuously surfaces ...

Validation is a process that, for many companies, remains manual despite having high costs, causing errors, and being crowded with inefficiencies.

The European Union has released the new (and very much anticipated) GMP Annex 1 revision after 14 years of development!

The basis for continuous manufacturing is modern monitoring and controls. However, to fully utilize them, we need advanced analytics applications—and this is where process analytical technology (PAT) comes into play. ...

The Cell and Gene Therapies industry is growing at a tremendous speed, building both on innovative solutions and a solid investment by life science companies who wish to diversify their market offer.

The new ICH Q14 guideline arrived to harmonize science and risk-based approaches for Analytical Procedure Development.

Recent world events have been showing pharma companies the importance of having an effective business continuity plan (BCP). Risk management is a crucial part of the business continuity plan, but it can be a challenge ...

In this article we will discuss the ever growing importance of Quality Risk Management in the context of Lifecycle Management.

Tech Transfers, or Technology Transfers, usually imply that you’re moving the manufacture of a drug from one facility, one scale or one drug lifecycle phase to another. Which is why they are so important. When you ...

The quick growth of the Cell and Gene Therapy created a great deal of enthusiasm in the biopharma industry. But, despite the merits they hold for patients, there are still some challenges when it comes to minimising ...

Biosimilars have been experiencing an impressive growth in the last few years. And it’s no wonder because Biosimilars have, on average, a high rate of cost-effectiveness. This is becoming much more important in a world ...

Currently, the industry is facing a very high demand for biologics such as large proteins or vaccines. Because of that, bringing a Continuous Manufacturing (CM) process to these types of products, will improve their ...

Cell and Gene Therapy (C>) is a fast-growing field, and that fast growth brings challenges to its development and manufacturing process.

When we discuss Quality Risk Management, we often focus on the operation, shop floor side of the processes. Today we’ll talk about some of the key aspects of QRM for the top-tiers of the Pharmaceutical Companies and how ...

When working with continuous cell culture processes, a perfusion-based mode of operation allows to increase productivity, maintain consistent quality and reduce process variability, since operating in perfusion provides ...

The industry of medical cannabis keeps growing. And we’re at the point where legislation is starting to catch up with. In fact, we expect GMP compliance and certification to become standard, just like the other ...