All About Data Integrity by Design

Computer system validation has been regulated by FDA for more than 40 years, as it relates to systems used in the manufacturing, testing, and distribution of a product in the pharmaceutical, biotechnology, medical device or other FDA-regulated industries. The FDA requirements ensure thorough planning, implementation, integration, testing and management of computer systems used to collect, analyze and/or report data.

Electronic records and electronic signatures (ER/ES) came into play through guidelines established by FDA in 1997, and disseminated through 21 CFR Part 11. This code describes the basic requirements for validating and documenting ER/ES capability in systems used in an FDA-regulated environment.

In the early 2000s, FDA recognized they could not inspect every computer system at every regulated company and placed the onus on industry to begin assessing all regulated computer systems based on risk. The level of potential risk, should the system fail to operate properly, needed to be the basis for each company’s approach to developing a validation approach and rationale as part of the planning process. System size, complexity, business criticality, GAMP 5 category and risk rating are the five key components for determining the scope and robustness of testing required to ensure data integrity and product safety.

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle.

This webinar is intended for those involved in planning, execution and support of computer system validation activities, working in the FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products (e-liquids, e-cigarettes, pouch tobacco, cigars, etc.). Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, regulatory affairs and submissions, adverse events management, and post-marketing surveillance.

The program will provide you with a current snapshot of the state of industry and FDA as both forge ahead in the face of ever-changing technology. The course provides insight into the ways in which Pharma 4.0™ will serve as an enabler for next generation medicinal products and new business cases for established products. The organizational, cultural, and technical processes and resources are key to the success of this endeavor.

The attendee will learn about Pharma 4.0 and the 4.0 Operating Model. We will discuss how Pharma 4.0 is governed by health regulations and some of the industry best practices that can help improve efficiency and effectiveness.

Pharma 4.0 can expand the connections between companies, FDA, and other stakeholders. During the course, we will review specific business cases for using Pharma 4.0 to determine the return on investment of Pharma 4.0.

We will discuss organizational and cultural practices that are essential to Pharma 4.0 success. We will cover the Pharma 4.0 Maturity Model and how this can provide a competitive advantage to a company.

Clearly, Pharma 4.0™ is not a must, but a competitive advantage. Missing Pharma 4.0™ might be a business risk. When moving from blockbusters to niche products and personalized medicines, Pharma 4.0™ offers new ways to look at business cases.

You’ll learn about the various stages of maturity for Pharma 4.0, moving toward a breakdown of silos in organizations and greater connectivity across the enterprise.

• Learn about the “12 Theses” of Pharma 4.0
• Pharma 4.0™ extends/describes the Industry 4.0 Operating Model for medicinal products
• In deference to common Industry 4.0 approaches, Pharma 4.0™ embeds health regulations best practices
• Pharma 4.0™ breaks silos in organizations by building bridges between industry, regulators and healthcare and all other stakeholders
• For the next Generation Medicinal Products, Pharma 4.0™ is THE enabler and business case
• For the established products, Pharma 4.0™ offers new business cases
• Investment calculations for Pharma 4.0™ require innovative approaches for business case calculations.
• Prerequisite for Pharma 4.0™ is an established PQS and controlled processes & products.
• Pharma 4.0™ is not an IT Project.
• The Pharma 4.0™ Operating Model incorporates next to IT also the organizational, cultural, processes & resources aspects.
• The Pharma 4.0™ Maturity Model allows aligning the organization’s operating model for innovative and established industries, suppliers and contractors to an appropriate desired state.
• Pharma 4.0™ is not a must, but a competitive advantage. Missing Pharma 4.0™ might be a business risk.
• When moving from blockbusters to niche products and personalized medicines, Pharma 4.0™ offers new ways to look at business cases.
• Computer System Validation (CSV)
• Computer Software Assurance (CSA)
• Waterfall Methodology
• Agile Methodology
• System Development Life Cycle (SDLC) Methodology
• GAMP®5 2nd Edition
• GAMP®5 “V” Model
• Automated Testing
• Critical Thinking
• Cloud Computing
• Software as a Service (SaaS)
• Q&A

Personnel in the following roles will benefit:

• Information Technology Analysts
• Information Technology Managers
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing Supervisors
• Supply Chain Specialists
• Computer System Validation Specialists
• GMP Training Specialists

So, what is next for the modernization of the processes involved in compliance for FDA-regulated systems, keeping in mind the guidance documents provide thus far? The FDA is embarking on a modernization program to update their technology and processes for working with industry to assure regulated products meet FDA compliance. There are numerous programs underway, including partnerships with other agencies and industry to move forward as technology continues to improve. The FDA plans to take advantage of these technologies, just as industry is focused on the same goal. The key is making sure these are employed in a way that promotes public health, providing more improved FDA-regulated products with fewer negative side effects and issues. Plans will also enable FDA to work with industry to move products to market faster, further improving public health.

Pharma 4.0 provides an operating model for FDA-regulated products. It embeds health regulations best practices in the model.

We will explore the best practices and strategic approach for evaluating the current processes involved in assuring computer systems used in the conduct FDA-regulated activities are modernized and streamlined. Cloud computing, automated computer system testing and mobile devices are just part of the mix we can expect to explode in the near term.

Finally, we will provide an overview of industry best practices, with a focus on data integrity and risk assessment that can be leveraged to assist in all your GxP work.

Midlothian, Virginia, United States

Carolyn Troiano has more than 40 years of experience in computer system validation and compliance in the pharmaceutical, medical device, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

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