We use cookies, similar technologies and tracking services

This website uses cookies, similar technologies and tracking services (hereinafter referred to as “Cookies”). These Cookies help to display our website, improve it based on your user behavior (e.g., via Salesforce Pardot) and present content aligned with your interests (e.g., LinkedIn Insights, Google Ads). We require your consent to use Cookies. Additionally, we incorporate content from third-party providers (e.g., Microsoft Azure for single sign-on authentication), which could involve transferring your data to the United States, a non-secure third country. By clicking Accept All, you consent to the use of non-essential Cookies and to your data being transferred to third countries. Clicking Refuse enables you to reject the use of non-essential Cookies. Please select which Cookies we may use under Details. More information, particularly about your rights as a data subject, is available under Details or in our Privacy Policy .

Details

Refuse

Accept

Below, you can activate/deactivate the individual technologies that are used on this website.

Accept All

Essential

These Cookies make a website usable by providing basic functions such as page navigation, language settings, Cookie preferences and access to protected areas of the website. Cookies in this category additionally ensure that the website complies with the applicable legal requirements and security standards. Owing to the essential nature of these Cookies, you cannot prevent their use on our website. Details about these Cookies are available under More Information.

Functionality and personalization

These Cookies collect information about your habits when using our web pages and help us to enhance your user experience by tailoring the functions and attractiveness of our web pages based on your previous visits, location and browser settings. They also enable access to integrated third-party tools on our website (e.g., Microsoft Azure for single sign-on authentication). This can involve transferring your data to the United States, a non-secure third country. If you refuse these Cookies, you might not be able to access the full functionality of the website. Details about the tools we use are available under More Information.

Analysis

These Cookies are used to compile basic usage and user statistics based on how our web pages are used. If you accept these Cookies, you simultaneously consent to your data being processed and transmitted to the United States by services such as Salesforce Pardot. Details about the tools we use are available under More Information.

Marketing and social media

These Cookies help third-party sources collect information about how you share content from our website on social media or provide analytical data about your user behavior when you move between social media platforms or between our social media campaigns and our web pages (e.g., LinkedIn Insights). Marketing Cookies from third-party sources also help us measure the effectiveness of our advertising on other websites (e.g., Google Ads). We use these Cookies to optimize how we deliver our content to you. The third-party sources and social media platforms we use can transfer your data to the United States, a non-secure third country. If you accept these Cookies, you simultaneously consent to your data being transferred and processed as described above. Details about the tools we use and our social media presence are available under More Information.

More information

Save Settings

Medical Engineering

In medical technology manufacturing companies, products are developed and manufactured that are used for the prevention, diagnosis and therapy of diseases. The production is subject to strict regulations and requirements, which is why quality assurance plays a prominent role in MedTech industries. In addition, the demand for medical technology products is increasing, which further increases the competitive pressure. The iTAC.MOM.Suite supports manufacturers in meeting the specific requirements of the market, from material delivery through production and testing to finally the shipping of goods.

The documentation of production processes and compliance with production specifications represent one of the greatest challenges in FDA-regulated manufacturing companies. Among other things, the requirements stipulate detailed documentation of all production-relevant processes and specifications, which involves a great deal of effort, especially in multi-stage and complex manufacturing processes.

The exact requirements are defined in FDA cGMP, 21 CFR Part 11 and 820, and further standards and guidelines are laid down in ISO EN13485. The latter refers to comprehensive quality management of medical devices. CFR 21 Part 11 indicates how electronic records and signatures are to be handled. In addition, the guidelines of GMP (Good Manufacturing Practice) apply, which prescribe the assurance of quality throughout the production process.

iTAC.MOM.Suite in Medical Manufacturing

MES/MOM solutions are used in production facilities in the pharmaceutical and medical industries to meet the specific requirements of international and national standards and guidelines, to satisfy the demands for complete documentation and traceability, and to provide the market with a flawless and safe product.

In the iTAC.MOM.Suite, BOM data and work schedules from the ERP system, work steps (such as assembly, testing, quality control, quality assurance, finishing & packaging), and specifications for each product are compiled into a Device Master Record (DMR). Specifications listed in the DMR include, for example, the bill of material, work plan, recipe, tools, employee qualifications, test plan, and operator guidance.

The documentation of the actual production processes for each individual item, i.e. the creation of a Device History Record (DHR), is also essential. Both DMR and DHR are created by the iTAC.MOM.Suite, making laborious, paper-based data collection, which is highly prone to errors, obsolete. Every process step, calibration and measurement data are taken directly from the respective systems and compared to the DMR. This ensures that the product is built according to specification.

In addition to absolute FDA conformity throughout the entire production process, seamless traceability is one of the most important goals for compliant production of medical devices. With Active Traceability, the iTAC.MOM.Suite ensures that quality problems in the production processes can be detected in real time, causes can be analyzed, and remedial actions can be evaluated systematically and promptly in a continuous improvement process.

Highlights & Benefits

Full compliance with all standards and requirements (ISO standard 13485, FDA cGMP, 21 CFR Part 11 and 820)

Implementation of paperless production and therefore enormous cost and time savings

Reduction of compliance costs with regard to FDA requirements

Complete production history with fully electronic DHR and electronic signature

Full transparency of the production process in real time

Active traceability: batch and serial number tracking across all production stages (end-to-end)

Prevention strategies through setup verification (no use of incorrect, defective or blocked components)

Process security through process interlocking

Worker management and release workflow

Audit trail

ERP integration