Ø-Evaluation (Last 27.04.2012)
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Manufacturers and suppliers of medical technologies have to adhere to the high demands of European medical product guidelines and the US Food and Drug Administration (FDA). In order to meet the related general requirements for validation and quality management many medical technology companies have been relying on CAQ AG Factory Systems software solutions with much success since 1998.
A company‘s CAPA-system is often at the center of an FDA-inspection. With CAQ AG Factory Systems software solutions you are able to define responsibilities as well as processes of corrective and preventative actions (CAPA) and implement these in order to achieve sustained corrections of errors. With CAPA error management (see explanation box) it is possible to collect, evaluate, and document efficiently deviations from standards, customer complaints, inspection monitoring, revisions, demands for changes, and the resultant procedures for corrections and preventions compliant with regulatory requirements.
Corrective and Preventative Actions, CAPA, is an instrument of integrated and comprehensive error management. At the core of the CAPA principle lies effective and systematic processing of quality flaws, errors, and disruptions to achieve adequate corrections and consistent prevention to avoid error occurrences. The US Food and Drug Administration (FDA) developed the CAPA principle for inspections of medical products.
Figure: CAPA demands QSR 21 CFR Part 820.100 CAQ CAPA Module: actions, corrective actions, preventive actions, evaluations, monitoring of procedures (reporting of incidents, customer rejections and returns, supplier rejections)Conventional manual, paper-based methods are slow, inefficient, and error-prone in comparison. They carry the risk that identified defects are monitored imperfectly and regulatory requirements are not taken into account adequately. Overall, processes for deviation and complaint management become more transparent, quicker, and therefore more effective. With the help of CAPA all existing or potential defects in products and errors in processing are recorded and evaluated. CAPA makes it possible to analyze trends based on collected data and gives users the necessary indications to compile effective corrective action plans.
The CAQ system documents and archives all information compliant with GxP, starting with deviations in production, to customer claims, to concisely applied actions with subsequent evaluation of effectiveness. CAPA accompanies product and processing quality from manufacturing, to distribution, to customer delivery, in short, along the entire value added chain. With the help of CAQ AG Factory Systems software solutions users can easily and transparently implement processes dealing with corrective and preventative actions pursuing the goal of eliminating permanently any error that occurred with products or processes. With the integrated, centralized procedure management users monitor and create actions, such as actions to prevent errors of identical or similar type with the same or comparable products or processes.
Define the CAPA-workflow and therefore the process and the CAPA team with our assistant. Every authorized employee receives his or her allocated information concerning product-relevant notices and can, subsequently, evaluate and control how the CAPA process unfolds. A CAPA process protocol with time-sensitive security information, initiators, responsible parties, as well as planned actions and analyses is created automatically. Therefore, you are always in possession of comprehensive documentation concerning the CAPA-process.
Create detailed evaluations of processes at any time. Whether you choose bar charts, circle diagram, pie chart, 3D-graphs, or classic list evaluations, all of these possibilities will give you a perfect and quick overview describing the up-to-date situation.
With our customized software modules we offer our users a software package with which they can implement a CAPA process quickly, simply, and in a structured manner. In this way you can create, very simply, a customized improvement management that allows you to create long-lasting and efficient goals and processes for improvements. Inspectors pay close attention to a well-functioning CAPA process in upcoming audits or FDA inspections. This guarantees that repetitions or errors and deviations can be eliminated. With CAQ AG Factory Systems‘ CAPA solution you can increase product quality, patient safety, and therefore customer satisfaction.
Companies change with the market; they change in size, their products and services develop with time and according to location. A company‘s software applications must therefore adapt dynamically to these transformations either in response to external or to internal regulatory specifications regarding compliance issues. This affects small and large, local and international companies. A company‘s path also aligns itself in response to internal demands, such as intrinsic value, continuity, etc.
Communication, confirmation, and correction are methods for making a company adaptable, to put it into a position to react to the market and react in a timely fashion in order to grow and expand. This leads to a Culture of Confidence™. Successfully implemented compliance management structures lead to satisfaction in business and to the ability to deliver better products and services as well as face new challenges. This is the basis for satisfaction in business. With our modular software solutions you will be able to successfully meet these demands. Our diverse software solutions, such as
will give you the flexibility to react to the strict demands of your quality management and optimize your quality assurance. Our software solutions will support you continually and reduce your costs.
With AuditTrail.Net® you are able to keep a record of any access, during or after the action, to documentation and database changes within the CAQ system. AuditTrail.Net® allows you to retrace any unauthorized access to your CAQ system, and any changes or deletion of data, or document and record manipulation. The software saves every data set or cell change in a separate file with date/time stamp, user name, and workstation. Consequently, this guarantees complete traceabilty of all changes to libraries and other database identities. The software user has no opportunity to avoid the protocol even if he or she tries to access the database manually. With AuditTrail.Net®, the software module that retraces database modifications, all changes of CAQ software databases are recorded.
No measurement or decision is lost with the help of polished retracing of lots, serial numbers, and bins. There is 100% traceability – down to the individual measurement – at every step of the manufacturing and quality process.
Just to be on the safe side, it is important to have all information at your fingertips. When was which part installed into which unit? When did which materials or lots get used in which products and to whom were the products delivered? What was the exact quality status of a process when a particular manufacturing or material lot was produced? Which qualitative parameter value existed during assembly of a particular unit and where did construction take place?
These are all questions that occur often in cases of rejection or damage but also during evaluation of field trials, prototypes, etc. These inquiries are usually handled in time and effort-consuming manual searches and must be collected, prepared, and evaluated by hand.
With sophisticated and flexible CAQ Factory Systems software solutions for lot administration you can document the production, implementation, mobility and storage of your products as well as your rendering of services at any time. Of course CAQ-Compact.Net® supports all methods of data entry: bar codes, direct input, mobile or stationary reader and input devices, and so much more.
The intelligent interface assures that all production and quality-related data end up exactly where they are needed, down to the individual measurement. This assures lasting transparency, clarity, and 100% bi-directional traceability.
If a standard operating procedure (SOP) is created or modified with the module QBD.Net®, the software automatically generates a training schedule that covers all roles and employees and sends a notification to all responsible parties – consistency at its finest.
Are you looking for the employee who is a perfect match for completing a specific task? One click and you have an overview of the complete requirement criteria that person must fulfill. Qualify.Net® does not just administer qualification and training verification but also notifies you in advance when a particular employee is up for requalification.
The software solution for planning, administration, documentation, and evaluation of qualification measures for your employees. Qualify.Net® makes it possible to plan, organize, document, and evaluate employee training simply and efficiently. The software generates appointments for necessary employee training sessions quickly and easily and displays these clearly. Training documentation, including place settings, can be printed if needed.
