Crucial Requirements for a Successful Validation Project
Posted on Mon, Jan 09, 2012
The FDA’s General Principles of Software Validation (GPSV), emphasizing how crucial requirements are to successful validation, recognizes the requirements for a successful validation project are difficult, if not impossible, to create accurately and to an adequate level of detail in one pass.
The recognition that requirements are “defined, refined, and updated as a development project progresses” indicates that the FDA clearly understands that it is unlikely that a project team will be able to adhere strictly to a traditional waterfall life cycle management model.
From the regulatory perspective, it would appear that system, software, design, and test specifications could all be made up of “requirements”. Consequently, although the philosophical debate over requirements versus designs is interesting to developers, the FDA treats them all the same.
The concept of a requirement is a relative term, instead of an absolute term. It is viewed simply as an input to an activity that results in some level of design output.
The evidence from GSPV Section 3.1.2, that all software requirements have been implemented properly, coupled with the understanding of the FDA’s relative requirement concept, gives a meaning beyond what in the industry have traditionally interpreted it to mean. The traditional interpretation has been the traceable evidence of verification to a specific document full of software requirements is required.
However, it is not uncommon for project teams to manage several documents at a pre-design level, only labeling a subset of them as “requirements” to avoid having to trace to the non-requirement documents and/or verify their correct implementation.
As the validation of computerized systems is a regulatory requirement for the FDA because of 21 CFR Part 11, validation can be treated as a proof of suitability that is linked to the whole system life cycle to ensure that the system meets the user requirements, ensure compliance expectations, and will properly maintained to guarantee a secure environment with accurate, reliable, and traceable information throughout its life cycle.
It is simply a process that starts with definition of requirements and ends with assurance that all needs are met.
Validation remains one of the important issues in the pharmaceutical industry as it has for many years. Validation is an important aspect in the age of global competition and the rapidly changing technology environment not because of the regulatory requirements only, but also for an effective, true approach in the long run for the computer systems used in the industry.
Validation is vital for organizational global competitiveness, growth, and compliance requirements. The basic aim is always to assure quality and the process is capable to develop a product meeting the predefined conditions and respecting all the applicable norms.
Validation teams are focusing on their role in the development of quality-orientation validation plans by providing valuable insight and guidance in order to keep pace with the latest changing technology. The major objective behind a validation strategy is always to assure quality for all deliverables of a computer system and to verify compatibility with all compliance (functional, security, integrity, etc.) requirements.
