PC Platform Supports Process Documentation

The fulfillment of the requirements according to these guidelines, however, does not happen by itself. For the achievement of the authenticity, integrity and confidentiality of electronic documents and signatures, the requirements and input on the part of the user are tremendous. System compliance with Part11-conformity requires the generation of audit trails for the complete capture of operator control actions. These actions have to be secured against deletion. Data changed at an earlier stage must remain visible, and the person responsible for the change must be identifiable. The audit trails themselves have to be made available to the FDA for control and duplication purposes. The FDA defines the validation process as “the process of established documented evidence” which provides a high degree of assurance that a system will consistently operate according to its predetermined specifications and quality characteristics.

Access to the systems has to be monitored by access control management and has to be defined in order to reliably prevent unauthorized data access. Each electronic signature shall be unique to one individual and shall not be assigned to anyone else. The purpose is the unquestionable validity of each signature for the signed activity. Non-biometric electronic signatures need at least two separate identification codes. They are usually the User-ID and the password. They must be prepared and managed in such a way that at least two individuals are required for a duplication of the signature.

While most diverse PC-based product solutions such as panel PCs, industrial PCs or PC service stations can be used in the safe area of a pharmaceutical industry production plant, plant areas that are classified as Ex-areas, according to category II 2G (zone 1) and category II 3D (zone 22), use several Extec PCEX 410/412 panel-PC units as plant visualization systems. These panel PCs are connected to the process control system via Ethernet TCP/IP and are integrated as clients in a validable Ethernet-based client/server architecture.

The validated SCADA software package Procon-Win from GTI-Control is used as application software. By using the module “FDA conformable user administration”, the rules of 21 CFR Part 11 are adhered to. Changes in the system will be logged in the audit trail with the associated signature and time stamp. The written data is protected against access from unauthorized users by incorporating electronic symbols and series of symbols. Consequently, the electronically recorded data acquire a legally binding character which can be equated with a handwritten signature and allow for a fail-safe traceability in the production area.

The functionalities of these SCADA and HMI solutions, which, apart from unlimited data storage, include a complex error and alarm control system as well as an integrated multilingual package, can run on practically all PC-based system solutions. You are always ensured of short response times for control and rapid image sequences. Object-oriented and library-supported project planning allow simple and quick generation of applications.

The Extec model PCEX 410 with its 10.4" TFT display and a resolution of 800 × 600 pixels, including integrated touch screen, will satisfy high demands for data input. Its substantial keyboard, with 24 function keys and slide-in labels, LED as well as number and cursor lock, allow keyboard-oriented operation for the visualization of the processes and machines.

The Extec model PCEX 412 with its 12" display and 1024 × 768 pixels follows the trend towards a keyless system control. A few keys, such as the left and right mouse button or four extra keys which can be allocated to any function, complete the touch screen functionality and provide outstanding ease of operation. The PC platform of the product range PCEX is based on a fanless 400 MHz processor, 256 MB RAM user memory and a 20 GB hard drive. For the use in the rough industrial environment, the front is made with a spill-proof design, which is in accordance to the IP 65 standard. Stainless steel assembly casing, also in customer-specific design, are also available.
Apart from the Ethernet network interface, serial interface is available, which can exchange data alternatively or together with the plant, the process control system or via the Intranet or Internet. The interfaces are connected to the terminal block at the back of the devices. The terminal blocks are produced according to the requirements of protection type “increased safety”, as per EN 50019. This ensures easy connectivity to the process control system in the safe area without any further security measures. If required, an additional keyboard, a mouse and a barcode reader for extended data capture can be connected to three integrated, intrinsically safe interfaces.