Blockchain Innovations for Pharmaceuticals and Healthcare

Introduction

Blockchain in the full-blown sense has yet to be accepted by pharmaceutical  regulators; however, the U.S. FDA agreed in 20198 to a pilot study. This blog posts looks at what blockchain is and how it might work in the context of pharmaceuticals and healthcare. This post also looks at areas where blockchain can be directed and what advantages it can deliver to pharma. Of these different applications, avoiding the falsification of medicines is probably the most important. 




Product Added Successfully

This product has been added to your account and you can access it from your dashboard. As a member, you are entitled to a total of 0 products.

Do you want access to more of our products? Upgrade your membership now!

Your Product count is over the limit

Do you want access to more of our products? Upgrade your membership now!

Product added to cart successfully.

You can continue shopping or proceed to checkout.

Computer System Validation & Data Integrity

For all the professionals in the Pharmaceutical and Biotech industries this is a daily and common topic, almost like the morning traffic report.  But, how do we get to that “route” that is going to provide a smooth ride to our final destination and in this case to a Mature Data Integrity state?




Creating Strategic Alliances Between Information Technology and Quality

Abstract

Managing software development life cycles (SDLC) has been an intellectual journey due to different models and methodologies to address what is required. On top of that, there is a diversified spectrum of opinions of what is the best approach. This can lead to the implementation of unnecessary requirements, and the introduction of many behavioral issues such as employees not understanding key roles and responsibilities. Therefore, questions surface that require an answer. For example, how can we successfully deliver Quality and IT services to the business? How will we effectively use Quality and IT resources? How are compliance projects managed effectively? The only way to move forward successfully is by moving into a collaborative approach where partnerships are formed to make a business more competitive. This article presents key points to help answer these questions and uncovers foundational blocks of collaboration, useful across organizations. 

Introduction

In today’s pharmaceutical and biopharmaceutical environments, there are a slew of SDLC models and interpretations. The number of competing SDLC methods for software validation have resulted in compliance uncertainty for many organizations. The question is: what is the appropriate model or methodology that should be followed? It is well known that regulatory agencies are not looking for the type of model used (Food and Drug Administration, 2002); FDA’s position does not stipulate a specific methodology, just the method followed is auditable (evidence based) and complies with all applicable scientific requirements and regulations. Therefore, regulatory agencies look for a “delivery model.” In other words, the focus is on how an organization adheres to a methodology (which would be expressed in a company’s own SOP’s) and how evidence is provided that a software or system is validated. Therefore, whatever methodology is chosen, it will be auditable and compliant.  

You may have heard the term “scientific approach.” This is not a new initiative but a phrase that is evolving within the pharma and biopharma companies where they are shifting into a “scientific approach” to face challenges with the next generation of blockbuster drugs. Precisely, FDA Guidance recommends following risk based approach with software validation. In addition, the FDA Guidance for Software Validation (Food and Drug Administration, 2002) discusses the relevant scientific and legal requirements necessary to address in validation projects. 

This content is only available to IVT members.
Get help maintaining your knowledge in Computer & Software Validation. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




How to Optimize Each Step of a Document Control System

If you are developing or a document control system or if you are looking to improve your own, there are ways to optimize each step of the system. For document development, this discussion will help you get your processes right the first time, to speed up the time of document review, and to avoid last minute surprises. The “EMPTT” approach will be explored, which is a useful way to track the development of documents.   

An important way to begin is to think about what each step of a process looks like and think about what steps are needed.  Most of us know the basics of document creation: write the document, review the document, approve the document, publish the document and control the document.  There is a way to modify each of the steps. 

This content is only available to IVT members.
Get help maintaining your knowledge in Computer & Software Validation. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




The Qualification or Validation of Laboratory COTS Computerized Systems

Introduction

Advances in testing technologies have significantly increased the functionalities and controls of laboratory instruments through dedicated software over the two last decades. Regulatory emphasis for data security and safety has led to these software to be more compliant with current regulations. The vast majority of  software used in a laboratory are Commercial-off-the-shelf (COTS) applications that load onto local computers. The validation for a new system, or a remediation, approach for a Laboratory COTS application that normally resides within a company’s computerize system validation program can be cumbersome if the implementation is not planned. 

Computerize System Validation Approach

A common approach that is widely used is a System Life Cycle program with five or six phases (initiation, design or requirements,  installation/testing/validation, pperation, and retirement). Each phase has multiple deliverables which include:

  • Planning Documents
  • Lengthy Risk Assessments (GxP/Regulatory/Risk)
  • Design, Functional, User and Configuration Requirements Document(s)
  • Vendor Testing Protocols
  • User Acceptance Protocols
  • Traceability Matrices
  • Summary Reports
  • Release to Service Notices
  • Validation Documents or Deliverables Trackers

This content is only available to IVT members.
Get help maintaining your knowledge in Computer & Software Validation. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




GDPR, Paperless Validation, and More: A Review of IVT's 19th Annual CSV

IVT Network brought together key players at the 19th Annual Computer & Software Validation Annual conference to review up-to-the minute coverage of regulations, trends and procedures in CSV, data integrity, mobile medical devices, and software validation.




User Acceptance Testing and RTSM System Validation

4G Clinical is a cutting-edge randomization and trial supply management (RTSM) company focused on simplifying and accelerating the study start-up process through offering the 4th generation of RTSM technology.




Validation and Assessment of Computerized System Software in a Pharmaceutical Facility

The aim of this paper is to assess the current regulations relating to computer system validation, focusing on software (although reference is also made to hardware). The paper provides some best practice advice for the risk assessment of computerized systems.

This content is only available to IVT members.
Get help maintaining your knowledge in Regulation. Read More!

If you are already a member and you do not have access to this article, upgrade your membership.
Need help? Read our FAQs.




Implement a Validation Plan for Legacy Computer Systems

Peer Reviewed: Computer and Software Validation


INTRODUCTION

One of the biggest challenges some companies have is the validation of legacy computer systems.