ISO 13485 Software for Quality in the Medical Device Industry

Manufacturers and suppliers of medical technology must adhere to the rules and regulations of ISO 13485, the European Medical Device Regulation (MDR) and the US Food and Drug Administration (FDA). The sophisticated CAQ.Net^® software solutions enable medical technology companies around the globe to fulfil these stringent rules and regulations and successfully master all associated quality management and validation processes.

Amongst other aspects, the framework conditions that must be adhered to when manufacturing medical technology 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, companies 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 that is needed, is CAQ.Net^®.

Compliance Management

CAQ.Net^® is a user-friendly modular software solution that facilitates the adherence to internal and external requirements as well as regulatory and legal obligations. It allows companies to conduct comprehensive compliance management in a well-structured manner that corresponds to obligations relating to MDR, GxP, FDA, ICH, ISO 13485, 21 CFR 820, ISO 14971, and 21 CFR Part 11.

CAPA - Corrective and Preventive Actions

In the spirit of a holistic CAPA Software, CAQ.Net^® incorporates cross-modular CAPA measures compliant with ISO 13485 / FDA 21 CFR 820.100, which accompany you along the entire product lifecycle – from advanced product quality planning to complaint management. The CAPA functions allow you to create and apply extensive corrective and preventive actions at all times. These actions enable an effective and systematic treatment of quality defects, errors, and disruptions in accordance with the concept of prophylactic and preventative failure and error management.

With CAQ.Net^® you can easily establish whether the root cause of a problem lies in the raw materials delivered by your supplier, poorly trained personnel, or a faulty step in the production process. The system, however, goes one step further and allows you to eliminate the possible causes of a CAPA well in advance during the initial product development process. For this purpose, CAQ.Net^® provides you with a whole host of techniques and tools that cover virtually every facet of quality management in a modular manner.

Supplier Control

ISO 13485 requires that a clearly documented system is put in place which controls the purchasing of external products. A purchasing company must define the precise criteria by which it inspects, selects and audits its suppliers. The FDA demands similar measures in section 820.50 “Purchasing Controls” of its Title 21 Part 820 “Quality System Regulation” – and emphasises these prerequisites via its feared “Warning Letters”. That is only one of the reasons why virtually all ISO/FDA-relevant requirements are available in the supplier management module of CAQ.Net^®.

The seamless interconnection of the various CAQ.Net^® modules is of course also of great importance with regard to supplier management. In order to execute an expressive supplier management it is necessary that you have direct access to all available data and can evaluate said data simultaneously. The clear advantages of CAQ.Net^® lie in the fact that all data you gather that is relevant to the relationship between your company and your supplier – such as supplier self-evaluations, audits, complaints, CAPAs, risk-analyses or incoming goods inspections – can be analysed in one go and be implemented to achieve a crystal clear supplier evaluation.

Records Management & Audit-Trail

The change control used in CAQ.Net^® 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 touch of a 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 ISO 14971 is essential for manufacturers and suppliers of medical technology. CAQ.Net^® actively supports you in the implementation of this standard and offers you tools such as the before/after risk-matrix, advanced risk evaluations, as well as the 3D signal lamp factor, which all allow you to practice effective and precise risk management.

Training & 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 ISO 9001 and monitor qualification and training measures. Whether creating, maintaining, controlling, or archiving documents – the document management system in CAQ.Net^® consolidates all aspects of document management. This, of course, includes the application of 21 CFR Part 11 compliant electronic signatures.

CAQ.Net^® also contains a powerful software solution for planning, administrating, documenting, and evaluating all training and qualification matters in your company. All of this provides effective assistance in complying with the documentation duties demanded by official standards.

Decades of Experience

CAQ AG has over thirty years of experience in the area of computer aided quality assurance and quality management. Our first customers included a variety of manufacturers and suppliers of medical technology. 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.

Fully Validatable Standard Software

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 CAQ.Net^® and the most current requirements by manufacturers and suppliers of medical technology 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 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 CAQ.Net^®: your all-inclusive management solution for the medical technology sector.

Highlights

• Validated Conformity to Standards (ISO 13485, FDA CFR 21 Part 820, MDR, ISO 9001, ...)
• Traceability (21 CFR 820.65)
• CAPA Management (21 CFR 820.100)
• Risk Management (ISO 14971, FMEA, ...)
• Training & Qualification Management (21 CFR 820.25)
• Audit Management (21 CFR 820.22)
• Document Management (21 CFR 820.40)
• Supplier Management (21 CFR 820.50)
• KPI Management & Quality Control (21 CFR 820.20)
• Gauge Management (21 CFR 820.72)
• Complaint Management (21 CFR 820.198)
• Incoming/Outgoing Goods Inspections & In-Process-Testing (21 CFR 820.80)
• Evaluation Planning with Statistical/Analytical Evaluation Functions (Trend Analyses, Status Reports, Control Charts, ...)
• Records Management (Subpart M)
• Quality Planning and Process Control Plans (Subpart G)
• Multi-Level Escalation Mechanisms (Review, Approval, Revision Control, ...)
• Freely Definable Rights-Management and Classification Workflow
• Comprehensive Change Control and Documentation
• Root Cause Analysis (RCA) with Ishikawa & 5-Why
• Electronic Signatures and Audit-Trail (21 CFR Part 11)
• Bidirectional Data-Exchange with External Systems (ERP, MDA, PDA, HRM, CMS, MES, …)
• Parameter Setting & Customization
• Multitenancy and Multi-Facility Support
• Web-/Cloud-/Mobility-Ready
• Consistent Application of Methods Such as PDCA, KVP & Kaizen
• And much more