Profile

One of our analysts was brought in to this international pharmaceutical giant to create a security "front end" behind which all existing FileMaker-based database systems in existence in that part of the company (as well as a brand new system under development by us) could be placed in order to meet every requirement of an electronic system in a strictly government-(FDA) regulated environment. (Because of our non-disclosure agreement, we can't show you actual screen shots of the system we built, so we'll show screens from a prototype that we had developed previously and upon which this system was based.)

Challenge

The primary challenge was coming up with a security "shell" that was intuitive, easily managed by a non-programmer, met each and every FDA (and every corporate Computer Systems Quality Control) requirement for electronic records/electronic signatures (called ER/ES for short) such that the system could be officially "validated" as a secure, accurate system approved for use with critical pharmaceutical manufacturing data. In addition, many of the existing systems that were to be put behind this security front-end were not built by "programmers" and had, in some cases, to be completely analyzed and in most cases partially or completely rebuilt first so as to be friendly with the new security module. At the same time we were able to remove and streamline the existing code for smarter, faster systems. Last, in addition to all of the programming, we wrote the complete validation "package" for each system which includes many-score pages of official documents covering the requirements, design, testing, security, periodic review, document location and control and approval process of the system for the company's permanent archive.

Solution

The solution we built uses a combination of FileMaker Pro, network security, FileMaker Server, and a few plugins to create a simple, easy to understand, easy to administer security shell that, we feel, in combination with the company's "wickedly comprehensive" physical security infrastructure, is generally impervious to nefarious attacks. In addition, the system was fully validated which means, at least in the eyes of this client, that the system will stand up against any computer system audit that the FDA might throw at it.

System

The security shell itself is made up of only three tables...the Main Menu, the Users file and the Audit Trail file. Any existing FileMaker system that needs to be plugged into the shell needs a few scripts and a few fields added to each table in the system, and the data entry layouts need to be slightly modified and locked down. The passwording scheme is also simplifed and standardized and, at that time, the code was fully commented and optimized.

Special Features

The Troi Coding plug-in is used to encrypt passwords in the system to avoid passwords from being intercepted on the network.