Synapse MES Medical Edition - the powerful Manufacturing Execution System that covers your entire production process!

Optimize your manufacturing processes in medical technology with camLine!

camLine - IT solution partner to the high-tech for more than 30 years to increase productivity, quality and process integrity.

In a world where compliance, traceability, and quality assurance are of paramount importance, the medical devices industry requires cutting-edge solutions to meet the increasing healthcare demands.

On the other hand, digitalization in the medical devices production is still limited. From batch sheets to quality checks, tasks are still commonly done on paper. All this paperwork needs to be physically stored or converted into digital format, which can be time-consuming. Although it's currently the common practice, given the numerous steps and intricacy, paperwork tends to pile up and can easily become disorganized over time.

When the time comes for regulatory approval, certification, and audits, companies must provide the necessary documents on time to comply with the requirements. It gets more complicated when a Supplier Lot of a greater production chain needs to be tracked down in the case of a recall. Finding specific ones for the occasion can be time consuming and expensive if the data is not automatically and digitally stored.

With this in mind, can a properly digitalized system meet these challenges?

Corresponding to the current technological advancements, a digital solution covering the whole production process is the answer to this pressing question.

With the right solution, you can expect the following benefits:

-              A complete manufacturing process traceability from the start to finish,

-              A secured releasing and versioning quality and master data with electronic signature,

-              A secured and configurable Audit Trail,

-              A comprehensive track and trace system,

-              Easy configurable inspections,

-              And Data integrity & Data ownership security.

The powerful manufacturing execution system is an all-in-one discrete manufacturing execution solution. It ensures compliance, traceability, and quality control of product outputs, anytime and anywhere. It is easy to implement into your manufacturing system, helping you meet the standards for Good Manufacturing Practices within ISO 13485, 21 CFR Part 820, and other quality management system requirements.

It tracks every step of the manufacturing process, preventing errors, and ensures quality through real-time data and automated quality checks. With this, the products manufactured are up to the industry standard.

This solution facilitates an Electronic Batch Record (EBR) or Device History Record (DHR) , simplifying the production documentation process and traceability management. It streamlines operations, enhances efficiency, and ensures the safe production of medical devices.

The system is capable of documenting complete, consistent, and accurate data in accordance with the ALCOA++ documentation principles and with security checksum (SHA-2) against data manipulation.  This guarantees full data integrity, meeting regulatory compliances, and seamless audits.

This system supports EBR, allowing you to electronically track and document your manufacturing lots and units with a fixed timestamp. In the case of a product recall, EBR lets you quickly identify the affected products and all involved Supplier Lots, streamline the recall process, and protect customers.

The user interface shows a list of any incidents that may have occurred during charge processing, with each incident requiring justification and an electronic signature that follows the CFR Part 11. It’s activated for runtime situations, such as scraps, inspections, carrier manipulation, and other changes.

Versioning ensures the traceability of changes throughout the manufacturing process - what was changed, when and why it got changed, who made the changes, and who approved it.

On top of that, the audit trail feature allows you to set up your own configurations for the user actions, activities, or data changes required to document on the database according to your processes. It lets you stay on track with the documentation for future audits.

Let’s be audit ready and reach your manufactory’s full potential!

Leverage your quality assurance, traceability, and efficiency with InFrame Synapse MES Medical Devices Edition!

LineWorks SQM

Quality standard improvement on the supply chain

This add-on module for LineWorks SPACE helps you collaborate more closely with your subcontractors and suppliers at production sites distributed throughout the world. By means of electronic Certificate of Analysis (eCOA), you implement, verify, and continuously improve mandatory quality standards for your entire supply chain. This helps you reduce your efforts for incoming quality control (IQC). Or even you can skip this inspection in case of your trusted suppliers. Before the goods are dispatched, your suppliers will send you their quality data in the form of these electronic Certificate of Analysis, online. Automatically, all incoming data will be checked by SQM (Supplier Quality Management). Your suppliers will immediately be notified about SQM’s analyses results. Online, they will receive your approval for physical shipment of their goods. By doing so, just goods with proper standards will be in transit that meet both, your product specifications and your quality requirements.

For manufacturers

• Accelerate time to market with rapid integration of new members on the supply chain

• Shorten approval times for new supply chains having available a complete standardized quality report for the entire value stream

• Just in time delivery

• Just goods with proper standards are in transit

• Lower business risk and unnecessary cost by eliminating human errors for data entry and spec checking

• Save cost and time by reducing or eliminating efforts for incoming quality control (IQC)

• Share quality data throughout your fab in correlation with your suppliers' quality

• Improve production yield

• Increase productivity with fast, easy-to-use Web portal for data upload and notification

• Enhance quality insight through automated reporting, trend and supplier rating analyses

• Supplier ratings

For suppliers

• Save time and money by avoiding costly rejects – deliver only high faultless goods

• Increase productivity and efficiency with a consistent solution that helps implement mandatory quality standards according to agreements

• Increase supply chain dynamics

• Be compliant with individual policies using documented electronic Certificates of Analyses (eCOA)

Electronic Certificates of Analysis (eCOA) to be used for quality assurance on the supply chain

Manufacturers’ quality assurance issues lot or batch-bound Certificates of Analysis to their products actually manufactured. With regard to GMP (Good Manufacturing Practice) compliance, these certificates are used during transport as goods accompanying documents, especially in foreign trade as well as for security and control regulations. Their content lists the results of performed in-process tests or final inspections for approval, methods, and qualitative outcome. In addition, however, they also confirm that a regulated product meets its product specifications according to individual customer agreements. Without automation, the latter performance requirements can quickly lead to a significant use of your resources.

The solutions LineWorks SQM and LineWorks CQM offer the automated creation of electronic Certificates of Analysis (eCOA) which can flexibly be tailored to your individual customer requirements. The overall goal is the resource-saving drawing up of Certificates of Analysis and prompt availability of quality data on the entire supply chain. Approval processes for complete supply chains and for material movements will be streamlined such that just goods with proper standards will be in transit.

In conjunction with LineWorks SPACE as their backbone, LineWorks SQM and LineWorks CQM can fully show their potentials. The combination with the powerful online SPC system provides much more information, not only for supplier ratings or scorecards. You gain a much larger scope for your analyses, e.g. for correlations and Root Cause Analyses, with rules that, by determination, can trigger immediate countermeasures.

Cornerstone data analysis software allows efficient work to design experiments and explore data, analyze dependencies, and find answers you can act upon, immediately, interactively, and without any programming.

Save time and money

· Engineer oriented execution of statistics tasks without being burdened with statistics details

· Reduce the amount of experiments via statistically optimized experiment plans and speed up overall development

· Optimizing your executed experiments via structured planning, data collection, and result analysis

· Automatic capturing compact, reusable workflows

· Easy and fast correlation detection in the data even working on Big Data infrastructure

· Fast finding of a usable process model and root-cause analysis via exploratory and visual data analysis

· Easy investigations of how noise in the process variables influences the process responses

Gain more information with less effort by better usability

· Understand results quickly and easily

· Benefit from example use cases of others

· Reduce reporting effort by a direct link to MS Office (WORD, PowerPoint) including a template functionality

Endless possibilities: Design experiments, explore, and analyze data

· Apply Design of Experiments (DoE)

· Perform technical data analyses

· Model and optimize processes

· Investigate process sensitivity and learn how noise in certain process variables will propagate to the responses of the same process

· Capture workflow for re-use

· Present data at high quality

· Use extensive statistical functions

· Accomplish these tasks specifically and in record speed

· Build your own application with the Cornerstone Extension Language (CEL)

We speak your language
Cornerstone Extension Language (CEL)

Specially tailor Cornerstone to meet your specific needs. With Cornerstone Extension Language (CEL), for example, you can easily create applications, new dialogs, menus, and other analysis tools. The open architecture that is coupled with CEL makes it possible for the software to meet almost any specific requirements your organization may have. Or you can simply integrate the features provided into another software application.

CornerstoneR and the R Interface

The widely-used programming language and open-source software R is well-known for its nearly endless capabilities in Statistical Computing. Thus, the R interface in Cornerstone opens a door to powerful graphical and statistical tools, e.g., for Data Preprocessing, Analysis, and Machine Learning, making Cornerstone more powerful than ever before. Do not be worried if you are not familiar with the R language: camLine’s new free extension CornerstoneR provides already many flexible, state-of-the-art functionalities which can easily be accessed from Cornerstone without any coding knowledge

In the current economic climate, it is becoming increasingly important to reduce the cost of manufacturing technology development and reduce the time to market for new products. This is especially true for knowledge-intensive high-tech companies such as those in the semiconductor and photovoltaic industries, pharmaceuticals, etc. camLine offers a complete solution with software and services that enable companies to leverage their existing knowledge, optimize their R&D workflow and develop their manufacturing technologies faster and more cost-effective. Through close integration with already available MES, RMS, SPC and other solutions at the customer site, the transition from the initial idea to series production can take place much faster and more seamlessly.

To help achieve these goals, camLine offers the Process Development Execution System (PDES), XperiDesk. PDES improves project and technology planning, assists with preparation, and supports the consistent tracking of experimental technology development. It provides easy and flexible access to existing knowledge and enables users to make full use of their experiences and lessons learned.

XperiDesk supports cooperation in research institutions and safeguards the organization’s “knowledge advantage”

Fewer learning cycles

Reduction of development time and costs by reducing the number of development iterations

Do not relearn existing knowledge:
With XperiDesk, you can access and reuse knowledge, information and data faster and more effectively. Improve the collaboration between the different development departments, locations, and even collaboration partners in the supply-chains. Enable engineers to automatically create complete documentation and make full use of existing knowledge with XperiDesk.

The idea - XperiDesk Development cycle

Learn in an alternative way: Avoid unnecessary experiments with XperiDesk and accelerate development by using virtual prototyping. Use the knowledge-based process verification in XperiDesk together with TCAD simulation tools to gain knowledge early on and prevent avoidable, costly errors.

Learn more from experiments: Gain more knowledge with fewer experiment iterations. Use XperiDesk for the complete documentation of experiments, including experiment design and tracking, measurement data analysis, and the correlation and visualization of data and information. Accelerate data retrieval with customizable reports and flexible one-click information search.

Reduced cycle time

XperiDesk reduces the number of required experiments through consistently applicable experiment design and comprehensive information collection and documentation. This implies that valuable resources can be released for savings or further innovations.

XperiDesk avoids incorrectly defined experiments through virtual, knowledge-based verification, thus reducing the probability of scrap and plant downtimes due to contamination, for example.

Use and protection of Intellectual Property (IP)

Intellectual Property is valuable. XperiDesk makes IP immediately accessible to all engineers and enables them to protect it comprehensively and securely.

Use the fully documented IP for technology transfers and customer projects with XperiDesk. Enable application engineers to save time on technology transfer projects by providing access to historical and comprehensive development data with XperiDesk.