制药和医疗器械行业的生产说明和批次记录大部分是纸质的。竞争加剧和降低成本的需要鼓励人们评估各种方法，以减少维护生产文档所需的开销。本文概述了一个系统，用于评估和选择生产指令和批次记录的自动化解决方案。控制文书工作的电子系统集中在办公自动化领域。 这些系统不符合在FDA监管的环境中创建和控制文件的要求。满足这些需求的技术和应用正在发展，以满足FDA监管的制造业的特殊需求。

THE PRODUCTION INSTRUCTIONS AND BATCH RECORDS IN THE PHARMACEUTICAL AND MEDICAL DEVICE INDUSTRIES ARE FOR THE MOST PART PAPER-BASED. THE ADVENT OF INCREASED COMPETITION AND THE NEED TO REDUCE COSTS HAVE ENCOURAGED EVALUATION OF WAYS TO REDUCE THE OVERHEAD REQUIRED TO MAINTAIN PRODUCTION DOCUMENTATION. A SYSTEM IS OUTLINED HERE FOR THE EVALUATION AND SELECTION OF AN AUTOMATED SOLUTION FOR PRODUCTION INSTRUCTIONS AND BATCH RECORDS. ELECTRONIC SYSTEMS TO CONTROL PAPER WORK HAVE FOCUSED ON THE OFFICE AUTOMATION ARENA. THESE SYSTEMS FALL SHORT OF THE REQUIREMENTS FOR CREATING AND CONTROLLING DOCUMENTS IN AN FDA-REGULATED ENVIRONMENT. THE TECHNOLOGIES AND APPLICATIONS TO MEET THESE NEEDS ARE EVOLVING TO SATISFY THE SPECIAL NEEDS OF FDA-REGULATED MANUFACTURING.