This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity. The life cycle approach takes all aspects of validation into account throughout the life of the system and the data that it houses. The data is a key asset for any FDA-regulated company and must be protected through its entire retention period.

FDA requires that all computer systems that handle data regulated by the Agency to be validated in accordance with their guidance on computerized systems. This guidance was first issued in 1983, and the main points of focus remain consistent today, despite the number of years that have passed and the technology changes that have taken place.

The guidance was revisited for its application to the medical device industry, as the first issuance addressed pharmaceuticals. In 1997, 21 CFR Part 11 was issued to address electronic records and electronic signatures (ER/ES), as many laboratories and other FDA-regulated organizations began seeking ways to move into a paperless environment. FDA recently issued a new draft guidance for use of ER/ES in clinical investigations.

The guidance on validation has been modified with the FDA’s proposed draft guidance for Computer Software Assurance (CSA) in September 2022. Addressing the approach to software development, testing and release this includes Agency support for use of agile as an SDLC methodology, along with other non-linear approaches. It also opens the door to consider use of Artificial Intelligence (AI), Machine Learning (ML) and a host of other technologies in FDA-regulated systems. The intent is to avoid creating a huge regulatory compliance cost to industry that has prevented companies from embracing these innovations.

Along with CSA, GAMP®5, 2nd Edition was published in July 2022 and aligns well with the proposed draft from FDA. Both focus on critical thinking and following a risk-based approach to testing. Both are intended to improve efficiency and effectiveness of validation work.

This session will provide some insight into current trends in compliance and enforcement. Those based on technology changes will continue to have an impact as new innovations come into use in the industry.

Regardless of the technology you intend to validate or the scope of the project, functionality to be delivered and resources and time to manage, a project management framework is very well suited for this purpose. It will allow you to know when scope, time, resources or deliverables are off track and need to be reigned in. Project management gives you insight into how time is being spent, what skills are needed for what activities and tasks, whether your budget is sufficient, and any risks or decisions that must be managed to ensure success.

There are many tools for planning, executing and reporting on project management, but you do not need to get sophisticated here. A simple Excel or other type of spreadsheet can be used to do the job. Keep it simple, but know the limitations of any tool you use. Also, keep in mind all of your stakeholders, including resources assigned, IT and business management, Quality Assurance and any others that need to know you are keeping an eye on things.

If you plan the project well, keeping it on track and reporting effectively to a variety of stakeholders will be much easier. The hardest part is keeping it simple while achieving the objectives, but this can be done fairly easily. Whatever tool you use, you can create a template for use with an system validation project by adjusting it to reflect the technology, skills, scope, timeline, resources and budget needed to stay on track and be successful.

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 IT, research and development, manufacturing, Quality Control, distribution, clinical testing and management, sample labeling, adverse events management and post-marketing surveillance.

Learn how using a project management framework to support your validation effort can provide great benefit in terms of efficiency and meeting targets for deliverables. It will allow you to manage scope, resources, timelines, deliverables and other aspects of the work involved.

With a project management approach, you are better able to govern the entire set of activities and tasks required to be performed by a large number and variety of resources. Know when specific skills are required, how to handle dependencies of any task on another, and take into account risks, assumptions, constraints and opportunities for improvement.