Product category:
QC and QA systems
News Release from: The Profibus Group | Subject: Profibus in FDA validation
Edited by the Processingtalk Editorial
Team on 10 October 2005
Profibus in systems requiring FDA
validation
This article describes the measures that must be carried out during the use of Profibus in systems requiring FDA validation and the basis on which such a validation is performed
SUMMARY The production of food, beverages, luxury food, tobacco and pharmaceuticals is subject to especially high quality requirements prescribed by statute and monitored by the US FDA (Food and Drug Administration)
This article was originally published on Processingtalk on 9 Jul 2008 at 8.00am (UK)
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For this purpose, the FDA enacted rules for the regulation of electronic documents in 1997.
Measures for the consistent and comprehensible documentation of all steps involved in the production process are the focus of these rules.
Verification that a system meets FDA requirements during the manufacturing process is achieved in the course of a so-called system validation, which is then concluded with an official certification.
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Which measures must be carried out during the use of Profibus in systems requiring validation and on which basis such a validation is performed is the content of the following article.
1 LEGAL PARAMETERS FOR SYSTEM VALIDATION.
Part eleven of FDA 21 CFR contains a catalogue of requirements, which applies to the areas of pharmacy as well as the food, beverage, tobacco and luxury food industries.
Access control, proof of change, audit trails, electronic signature, archiving as well as reading of archived data all belong to the most important requirements of the FDA.
Electronic records and electronic signatures may be used, if their associated level of security against forgery is not less than that of paper documents.
FDA 21 CFR Part 11 describes requirements in general form and independent from automation systems and implemented communications systems.
For the purposes of automation, an interpretation under special consideration of the process control system is undertaken in other guidelines.
These include, for example, the following.
* GAMP: Good Automated Manufacturing Practice (international scope).
* NAMUR Recommendation (NE) 72: Standardisation association for measurement and control technology in the chemicals industry (German-speaking regions).
NE72 was created in accordance with GAMP and is equivalent to this guideline.
It views validation as an attendant measure of automated production systems throughout the complete life cycle of planning from the operations phase up to decommissioning.
In addition to the operator, the suppliers are also involved in the production, project planning, start-up and maintenance of a process control system.
Suppliers are defined to be control system manufacturers as well as installers (eg design, development and start-up firms).
Suppliers are also obligated to provide written verification that the installed system functions according to its specifications.
This verification is made within the framework of the so-called system qualification.
2 VALIDATION OF PROFIBUS SYSTEMS.
Profibus is an automation technology covering the entire spectrum of requirements for industrial automation as well as in the areas of production and process automation.
The consistent automation with Profibus, enables the system operator to profit from a simple qualification process in comparison to systems with multiple different fieldbus systems.
In connection with the requirements of FDA 21 CFR Part 11, it must be verified for the communications system used that electronic data are transmitted in unaltered form.
As Profibus is an open technology, which was specified by a consortium of companies, the international Profibus organization (Profibus International, PI) is accorded a special prominence.
In order to simplify the qualification process a guideline was established by PI that describes the supporting validation functions of Profibus.
The requirements of NE72, GAMP and FDA 21 CFR Part 11 formed the basis for creating these guidelines.
2.1 GUIDELINE "VALIDATION OF PROFIBUS SYSTEMS".
The guideline "Validation of Profibus Systems" concentrates on the technology-relevant aspects of validation, ie the Profibus specifications and their development process.
It simplifies the validation process of Profibus systems, by accounting for the validation-relevant aspects identical in each system of the Profibus technology.
Verification of the qualifications of the manufacturers of Profibus products can only be supplied by the manufacturers themselves (eg through a quality control system according to DIN EN ISO 9001 or customer audits).
It is also possible to have Profibus devices tested for conformity to standards under the established certification process and thereby procure a Profibus certificate.
By doing so, the effort required for validation can be reduced.
A risk analysis forms the core of a system validation.
The qualification approach is defined in this analysis, which identifies affected systems, categorises the risk and determines the validation effort.
The following questions were especially asked and answered in regards to the risk analysis with the establishment of the Profibus guideline.
* Why does the installation of decentralized field devices change the process of qualification? * What documents and guidelines are offered by the manufacturers or fieldbus organizations? * How does qualification with the V-model occur? * Which tools can be used for support in which phases? It was determined in the course of these investigations that an approach for decentralised systems must be pursued in the qualification of Profibus systems.
This is due to the open architecture of Profibus and the fact that the process control system and the field devices frequently originate from several different manufacturers.
Integral components of the validation guideline are four standard process instructions, so-called "Standard Operating Procedures" (SOP), for system configuration, installation, device exchange as well as operation and locking of devices.
They provide a substantial resource for execution of the qualification process.
2.2 STRENGTHS OF THE PROFIBUS TECHNOLOGY IN SYSTEM VALIDATION.
The strengths, by which the Profibus technology distinguishes itself in reference to system validation, lie in its proven abilities and the quality control system incorporated by Profibus for years.
* Profibus is a technology proven in thousands of installations worldwide: To date, a total of more than 12.6 million Profibus devices have been installed in the most diverse types of applications: Against this background, Profibus must be acknowledged as an operationally proven technology.
* Profibus is standardised in the international standards IEC 61158 and IEC 61784-1.
* The application and engineering aspects of Profibus are specified in generally available guidelines from Profibus International.
* PI has established a quality system for the creation and maintenance of specifications, guidelines and accompanying documents: The Advisory Board directs the development activities, which are processed in 5 Technical Committees (TC) with more than 50 work groups currently.
* The Profibus certification entity forms the basis for the high standard of quality for Profibus devices, which in turn allows for the error-free interaction of Profibus devices of various manufacturers: The test passed as part of the certification process is an important prerequisite for the unaltered transmission of data between Profibus devices.
* An assortment of installation guidelines are available for installers of Profibus systems, in which the correct set-up of Profibus networks is described.
2.3 VALIDATION PROCESS.
The complete life cycle of a system can be grasped in the widely distributed and generally recognized V-Model.
Each development step (left side) is assigned an equivalent test step (right side), which represents a step in the validation process.
The qualification of a system is defined in a Validation Master Plan.
All validation and upstream activities belong to the plan, for example, the calibration of measurement devices.
During qualification written verification that the Profibus system has been installed according to specification (Installation Qualification, IQ) and functions accordingly (Operation Qualification, OQ) is generated.
The relevant system documents are to be created for this purpose, in which test cases are written out in full for IQ and OQ respectively and which are bound to the result of the test, complete with date and signature.
The completed documents are to be presented at certification of the system by the FDA.
3 PROFIBUS VALIDATION: FINAL REMARKS.
The Standard Operation Procedures stated in the Profibus guidelines form a sustainable foundation for preparation of the qualification documents.
The preparation of documents for the specification of the Profibus system, as well as the corresponding documents for installation qualification, operation qualification and performance qualification, require a high degree of Profibus know-how and validation-related knowledge.
Therefore, the qualification process should always be attended by experts, who possess both detailed knowledge of Profibus as well as experience with system qualification.
In addition to technical knowledge, the use of suitable tools for the testing of Profibus systems is a decisive prerequisite for adequate system qualification.
Belonging to these tools are bus testers, with which fault-free communications can be verified and documented.
Article provided by Dr Matthias Romer Endress+Hauser Process Solutions AG, and Dr Peter Wenzel, Director Profibus Nutzerorganisation eV.
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