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.
