Using Audit Trails to Support Part 11 Data Integrity Compliance

In this webinar, we will explore the best practices and strategic approach for evaluating computer systems used in the conduct FDA-regulated activities and determining the level of potential risk, should they fail, on data integrity, process and product quality, and consumer/patient safety.  We will walk through the System Development Life Cycle (SDLC) approach to validation, based on risk assessment, and will also discuss 21 CFR Part 11 and data integrity, and the importance of managing electronic records and signatures appropriately.

We will also walk through the entire set of essential policies and procedures, as well as other supporting documentation and activities that must be developed and followed to ensure compliance.  We will provide an overview of practices to prepare for an FDA inspection, and will also touch on the importance of auditing vendors of computer system hardware, software, tools and utilities, and services.

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.

Areas Covered in the Session :

• Learn how to identify “GxP” Systems
• Discuss the Computer System Validation (CSV) approach based on FDA requirements
• Learn about the System Development Life Cycle (SDLC) approach to validation
• Discuss the best practices for documenting computer system validation efforts, including requirements, design, development, testing and operational maintenance procedures
• Understand how to maintain a system in a validated state through the system’s entire life cycle
• Learn how to assure the integrity of data that supports GxP work
• Discuss the importance of “GxP” documentation that complies with FDA requirements
• Understand the rationale for including an audit trail in a system, along with the downside of not doing so.
• Understand how procedural controls may be used in place of technical controls, where the capability is lacking and not feasible.
• Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
• Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
• Know the regulatory influences that lead to FDA’s current thinking at any given time
• Learn how to conduct a risk assessment on computer systems that will provide the basis for developing a validation rationale
• Understand the need to include an assessment of a computer system’s size, complexity, business criticality, GAMP®5 category and risk, should it fail, to develop a cohesive and comprehensive validation rationale
• Learn how to best prepare for an FDA inspection or audit of a GxP computer system
• Understand the importance of performing a thorough vendor audit to ensure oversight to the products and services they deliver
• Finally, understand the industry best practices that will enable you to optimize your approach to validation and compliance, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
• Q&A

Who Should Attend:

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, adverse events management and post-marketing surveillance.

Examples of who will benefit from this webinar include:

• Information Technology Analysts
• Information Technology Developers and Testers
• QC/QA Managers and Analysts
• Analytical Chemists
• Compliance and Audit Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Specialists and Managers
• Supply Chain Specialists and Managers
• Regulatory Affairs Specialists
• Regulatory Submissions Specialists
• Clinical Data Analysts
• Clinical Data Managers
• Clinical Trial Sponsors
• Computer System Validation Specialists
• GMP Training Specialists
• Business Stakeholders/Subject Matter Experts
• Business System/Application Testers
• This webinar will also benefit any vendors and consultants working in the life sciences industry who are involved in computer system implementation, validation and compliance.

Subject Background:

Computer system validation has been regulated by FDA for more than 30 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.

In particular, industry citations have increased as they relate to areas of Part 11 and data integrity. At the heart of these, is the ability to ensure that no original record is obscured, or is destroyed before the retention period has ended. The best way to preserve database records, those that are uniformly structured, is to place an audit trail on the file. The audit trail will create a new record every time a record is updated, including the old value, new value, date, time, person who authentically performed the modification to the record, and the reason for the change.

Companies are not aligning well with the Part 11 and data integrity requirements, and while many use audit trails, these are not always managed appropriately. In some cases, FDA has found that the audit trail was deactivated for a period of time, but this was not documented, or it was modified or deleted. Without this protection, it’s virtually impossible to follow the life cycle for any record from creation to disposition at the end of the retention period.

In some cases, audit trails exist, but do not require the user to enter a reason for a change to a record. This is a challenge when trying to reconstruct what happened, and not having the reason brings into question the validity of the record.

Some legacy stand-alone systems that include software loaded onto a local device, instrument, or piece of equipment do not have audit trail capability. This is not a valid reason for ignoring Part 11 and data integrity requirements. If no technical control is available, such as an audit trail, then a procedural control must be in place. In the case of a stand-alone system, the user would have to maintain a log of all changes made, and this could be done using a bound laboratory notebook or log book, or using Excel or some other means of tracking this information.

Not only do these companies risk being out of compliance, but they are not able to perform analysis and trending on the records to identify the reason behind changes. If it’s a consistent reason, it may be due to a training deficiency or have some other cause that should receive action.

Course Director: CAROLYN TROIANO

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, 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. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation. Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.