CAQ Solutions for Medical Technologies

The all-inclusive management solution for the pharmaceutical and medical technology sectors.

Producers and suppliers of medical technology and pharmaceuticals must adhere to the strict rules and regulations of the European Medical Device Directive and the US Food and Drug Administration (FDA). For over thirty years, many pharmaceutical and medical technology companies have put their trust in the software solutions of CAQ AG Factory Systems in order to fulfil the associated framework conditions and successfully master stringent quality management and validation processes.

• CAPA-Management
• Audit-Management
• Training-Management
• Action-Management
• Document-Management
• Risk-Management

The ISO 13485 and ISO 9000 framework conditions that must be adhered to when manufacturing medical and pharmaceutical products include the application of CAPA measures (Corrective and Preventive Actions), the warranty of consistent traceability and change tracking, the implementation of a standard compliant risk management system, and the deployment of effective training and documentation management processes. In order to be able to successfully comply with these various requirements, you need a management system that ensures consistent documentation and comprehensive monitoring, and allows rapid and cross-departmental reactions to any type of change: the management system you need is the CAQ.Net^® Medical Edition.

Our CAQ.Net^® Medical Edition is a modular software solution that was designed specifically for deployment in the medical and pharmaceutical sectors. It facilitates the adherence to internal and external requirements as well as regulatory and legal obligations, and compliance with official standards and guidelines. During the development of the CAQ.Net^® Medical Edition, special attention was paid to the medical and pharmaceutical regulations postulated by the GxP, FDA or ICH and formulated in standards and guidelines such as ISO 13485, 21 CFR 820, DIN EN ISO 14971, GMP, GLP, GCP or 21 CFR Part 11. All of this allows you to conduct comprehensive compliance management with a well-structured and easily usable software solution that ensures compliance with internal and legal obligations.

CAPA

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. CAPA makes it possible to analyse trends based on collected data and gives users the necessary indications to compile effective corrective action plans.

Define the CAPA-workflow and therefore the process and the CAPA team with the CAQ.Net^® Medical Edition. 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.

The CAQ.Net^® Medical Edition incorporates cross-module CAPA measures that accompany you along the entire product lifecycle – from advanced product quality planning to complaint management. This allows you to create and apply extensive corrective and preventive actions at all times. These actions enable effective and systematic treatment of quality defects, errors, and disruptions in accordance with the concept of prophylactic and preventative failure and error management.

Traceability

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, complaint, 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.

The sophisticated and flexible CAQ.Net^® Medical Edition allows you to electronically document the production, implementation, mobility and storage of your products as well as your rendering of services at any time. Of course the CAQ.Net^® Medical Edition supports all methods of data entry: bar codes, direct input, mobile or stationary reader and input devices, and so much more.
Far reaching batch, serial number, nest and horde tracking functions in the CAQ.Net^® Medical Edition ensure that no measurement value and no decision is lost. The comprehensive traceability throughout all levels of production and quality assurance allow you to fulfil the traceability obligations contained in applicable standards and guidelines.

Compliance Management

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 the CAQ.Net^® Medical Edition you will be able to successfully meet these demands. It gives 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.

Records Management

The change control used in the CAQ.Net^® Medical Edition means that changes made to records, products, or systems are consistently and comprehensively documented. A separate structure is used in order to record the date/time, username and workstation when changes are made. This allows you to precisely identify, when who made what changes where. Hence, the fulfilment of all relevant documentation duties takes place in the background, and, at the click of button, you can immediately receive all e.g. audit-relevant change information as stipulated by applicable standards and regulations.

Risk Management

Applying risk management in accordance with DIN EN ISO 14971 is essential for manufacturers and suppliers of medical technology and pharmaceuticals. The CAQ.Net^® Medical Edition actively supports you in the implementation of this standard and offers you tools such as the before/after risk-matrix, FMEA evaluations with risk matrices, as well as 3D signal lamps, which allow you to practice effective and precise risk management.

Training and Document Management

An efficient and effective training and document management system is vital in order to successfully tackle the documentation duties of ISO 13485 and DIN EN ISO 9000 and monitor qualification and training measures. Whether creating, maintaining, controlling, or archiving documents – the document management system in the CAQ.Net^® Medical Edition consolidates all aspects of document management. This, of course, also includes the application of 21 CFR Part 11 conformant electronic signatures.
The CAQ.Net^® Medical Edition also includes a powerful software solution for planning, administrating, documenting, and evaluating all training and qualification matters in your company that provides effective assistance in complying with the documentation obligations demanded by official standards.

Decades of Experience in the Medical Sector

CAQ AG has thirty years of experience in the field of computer aided quality assurance and quality management. Our first customers included a variety of manufacturers and suppliers of medical technology and pharmaceuticals. Over the decades we have continued to support said customers in the implementation and maintenance of our standard-compliant software solution and many of these customer relationships have since developed into knowledge sharing partnerships. These partnerships allow us to continuously improve our product and rapidly adapt to changing industry demands.

We also work in close cooperation with a variety of partner companies who are specialized in qualification and validation procedures in the medical field. The resulting target/actual comparison between the CAQ.Net^® Medical Edition and the most current requirements by manufacturers and suppliers of medical technology and pharmaceuticals means that our customers are always in command of a cutting-edge software solution that allows professional, efficient, and standard-compliant quality management.

A holistic Management Solution

Successful quality assurance and management in the field of pharmaceuticals and medical technology requires an all-inclusive management solution that covers all quality-related facets from product design to complaint management and safeguards consistent compliance and traceability. This solution must also incorporate all aspects of CAPA management and facilitate the adherence to valid standards and guidelines. This solution is the CAQ.Net^® Medical Edition: your all-inclusive management solution for the pharmaceutical and medical technology sectors.

Highlights

• Flexible workflow management
• Individual modes of notification (e.g. e-mail, text messaging)
• Integrated evaluation planning with statistical and analytical tools and graphics
• Escalation management for status, action, and maturity follow-ups including definition of target/actual dates and responsibilities
• Intranet and internet support
• Freely define actions via JobControl.Net^®
• Escalation mechanisms at several levels (review, approval, revision control, etc.)
• Unrestrained control over classification and authorization for every document
• Embedding and control of existing documents as well as applicable documentation
• Linking of documents
• Electronic signatures (compliant with 21 CFR Part 11)
• Acquiring, administering, and evaluating of internal and external actions and their errors, as well as costs
• Evaluating actions according to effectiveness
• Comprehensive security concept
• Fully automatic, continuous, and bi-directional data exchange with external systems
• Automatic „reminder mechanism“ via e-mail or intranet
• Quick overview over up-to-date CAPA process status
• Satisfies demands of GMP, FDA QSR 21 CFR Part 820, 21 CFR Part 11, ICH
• Comprehensive modification control and documentation with AuditTrail.Net^®
• And much more