PC Platform Supports Process Documentation
Extec industrial PCs allow the use of standard HMI/ SCADA software
Savings in time and costs were the mainspring of the North American pharmaceutical industry, when it addressed the Food and Drug Administration (FDA) during the 1990's in order to set out on a joint and standardized approach towards paperless systems, because information and data is exchanged and analyzed more rapidly electronically than in paper form. There is no doubt that a target-oriented and automated implementation of the FDA guidelines is leading to a more cost-effective quality assurance and a reduced defect potential of the product. The main advantage, however, is the fact that the implementation of these guidelines puts the accountability and certification process for product approvals on a standard, comparable and easily reproduced basis.
The FDA guideline 21 CFR Part 11 defines the specifications which recognize electronic documents and electronic signatures equal to paper documents and signatures by hand. These specifications refer to all documents which have to be kept by mandatory requirement of the FDA, if these are produced, edited, changed, accessed, archived or transmitted in electronic form.
Trust is good…
Extec Panel-PC: Display and operator panel for the safe and hazardous area
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.
Application in the pharmaceutical industry
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.
Principal architecture of a solution for pharmaceutical industry
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.
Flexible in explosion-hazardous areas
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.