Nitahara K
META Solutions, Inc., Warren, New Jersey 07059.
Qual Assur. 1993 Mar-Jun;2(1-2):96-101.
In summary, the validation of purchased software and add-on programs requires careful examination of the situation to determine the most effective and logical methods. A standard validation methodology that is used for larger systems would be difficult and possibly dangerous to employ for a PC system because of the significant differences between the environments. It should be noted, however, that there are almost daily changes in the computer software industry. A number of potential solutions have emerged over the past few years that can be applied to reduce the concerns caused by the apparently insufficient controls in the PC environment. For example, currently available technologies would permit multiple PC users to access a secure central application or repository of data and prevent them from making changes to a validated system or database. A properly designed system could enable these distributed users to use the data to perform their required functions, while maintaining a validated state.
总之，对所购买的软件和附加程序进行验证需要仔细审视具体情况，以确定最有效且合理的方法。由于大型系统与个人计算机（PC）系统的环境存在显著差异，用于大型系统的标准验证方法应用于PC系统会很困难，甚至可能有风险。然而，应当注意的是，计算机软件行业几乎每天都在变化。在过去几年中出现了一些潜在的解决方案，可用于减少因PC环境中明显控制不足而引发的担忧。例如，目前可用的技术可使多个PC用户访问安全的中央应用程序或数据存储库，并防止他们对经过验证的系统或数据库进行更改。一个设计合理的系统能够使这些分布式用户利用数据来执行所需功能，同时保持验证状态。
