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.
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.
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