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News
Aligned Elements V1.7 released
June 2010
Aligned AG releases Aligned Elements V1.7, a version where we have made an extra effort to expand the compatibility scope, improve reliability and performance. Aligned Elements is
a dedicated system for managing Design History Files to ensure exceptional transparency, consistency and control using a minimal effort.
Aligned Elements integrates the processing of Requirements, Specifications, Risks, Tests, Design Reviews and Defect Tracking with Traceability Management, automated Consistency Checks, bi-directional integration with Microsoft Word, Digital Signatures and much more.
“Aligned Elements V1.7 incorporates a large number of new features suggested by our existing customers, including improved Word synchronization, faster full text search, expanded query options etc. We have also made Aligned Elements x64 compatible and it now operates on Windows 7 as well as with SQL Server 2008." - claims Karl Larsson, Marketing Manager at Aligned
Levitronix releases next generation of CentriMag
June 2010
Levitronix GmbH (www.levitronix.com) launched the next generation of its CentriMag® Console and Monitor. The CentriMag® System controls and monitors the operation of the magnetically levitated medical blood pump. The system is CE approved and available for European market.
Levitronix uses Aligned Elements for its DHF documentation.
Business Case Study - Tecan saves time and money with modular DHFs
May 2010
Tecan - a leading player in the pipetting robot indcustry - manages to reduce their Design History File set-up time with up to 80%. By applying a modular DHF structure Tecan obtains an exceptional degree of DHF reuse, saving both time and money.
Download the full article here: [here]
IFTEST AG choses Aligned Elements
April 2010
IFTEST - Systems partner for industrial and medical electronics - EMS provider with a comprehensive service portfolio
Iftest AG is a systems partner for innovative industrial and medical electronics with a comprehensive range of services. As a reliable and skilled partner, Iftest AG has already had 25 years of success in the development and production of electronic devices.
IFTEST uses Aligned Elements to compile their product development documentation.
Turn the regulatory challenge into a competitive advantage
March 2010
"...By adopting a traceability tool, manufacturers can considerably reduce the time spent on compuiling regulatory documentation for market submissions. Aligned's Karl Larsson explains how...", in the April edition of Medical Device Developments.
Download the full article here: [here].
Aligned Elements supports Nunit integration
February 2010
Aligned Elements allows import of Nunit test results and the possibility to perform a large number of regular Aligned Elements-actions on these results. By combining the benefits of automated unit tests with the powerful analysis features of Aligned Elements, time is saved, quality is increased and trace coverage is expanded.
Read more: [here].
Download the integration package: [here].
Aligned releases Aligned Elements V1.6 Service Pack 5
January 2010
Aligned released Service Pack 5 for V1.6 on January 12th. This service pack includes full test search for linked projects, on-the-fly load of linked projects and visualization incoming traces from other projects along with a number of bug fixes.
Demonstration of Aligned Elements at Altran Event
January 2010
Altran – global partner for innovation – offers a platform for firms to get acquainted with the wide-ranging capabilities of Aligned Elements. The demo of this Design History File Management software will be held at Altrans Zurich Office in the end of January 2010 and in early March 2010.
Aligned participates at the Medical Cluster symposium "Fullfilling regulatory requirements using modern tools - Compliance made easy"
December 2009
Medical Cluster hosts the [INSIGHT] event "Fullfilling regulatory requirements using modern tools - Compliance made easy" where Aligned presents Aligned Elements for Design History File Management.
Aligned is invited together with inMedis, MAJESTY, bayoonet and Babtec to demonstrate how their products can make the regulatory challenges easier to deal with.
The event takes place on January 26th in Museum Franz Gertsch in Burgdorf. To attend this event please use this link |Apply| and send in your application.
Aligned releases Aligned Elements V1.6 Service Pack 4
November 2009
Aligned released Service Pack 4 for V1.6 on November 17th. This service pack closes a limited number of open issues regarding handling of MS Word instances, error reporting and linked projects.
Aligned exhibits at Swiss Innovation Forum, Basel on Nov. 5th
October 2009
On November 5th 2009, Aligned exhibits at the Swiss Innovation Forum in Basel. We have been invited to participate as a partner of Altran (Stand 24). The 4th Swiss Innovation Forum will take place at the Congress Center in Basel. Your registration will be accepted under following link: registration
We look forward to see you there.
Aligned releases Aligned Elements V1.6 Service Pack 3
October 2009
Aligned released Service Pack 3 for V1.6 on October 18th. This Service pack focus on reliability with more than 90 open issues closed.
Enigma Diagnostics selects Aligned Elements
September 2009
Enigma Diagnostics Limited is a recognised leader in developing rapid diagnostics for the detection and identification of infectious organisms, such as bacteria and viruses, in environmental, clinical and biological samples.
Enigma develops portable and totally automated PCR (polymerase chain reaction) based diagnostic instruments that provide rapid and decisive results in real time allowing the user to take immediate action at the point of care.
Enigma has chosen Aligned Elements for its Design History File Management.
Aligned is now member of Medical Cluster
September 2009
As of September 2009 Aligned is official member of the Swiss Medical Cluster. The Medical Cluster brings together manufacturers, suppliers, service providers and research and development firms along the medtech value-added chain from throughout Switzerland. The association has more than 100 members.
More information about the Medical Cluster can be found at www.medical-cluster.ch.
Endosense receives CE mark for Tacticath® force-sensing ablation catheter
August 2009
We are happy to announce that one of our customers, Endosense, a medical technology company focused on improving efficacy, safety and reproducibility of catheter ablation for the treatment of cardiac arrhythmias, has received the CE mark for its TactiCath system. The first and only force-sensing ablation catheter developed worldwide, TactiCath gives physicians a real-time, objective measure of contact force during the catheter ablation procedure.
The CE mark allows physicians across Europe to use TactiCath in the treatment of supraventricular tachycardia (SVT) of the right atrium.
“The CE mark for TactiCath opens new horizons for Endosense, as we are establishing a new standard in the catheter ablation treatment of cardiac arrythmias,” said Eric Le Royer, president and chief executive officer of Endosense.
Endosense uses Aligned Elements for managing the Design History Files of their products.
Aligned releases Aligned Elements V1.6 Service Pack 2
June 2009
Aligned released Service Pack 2 for V1.6 on June 14th. This Service pack focus on security issues and closes a number of open defects reported for V1.6 SP 1.
Tecan uses Aligned Elements E-Signatures in their Design History File Management
June 2009
Tecan AG is a leading global provider of laboratory instruments and solutions in biopharmaceuticals, forensics, and clinical diagnostics. Tecan specializes in automation solutions for laboratories in the life sciences sector. Since 2007, Tecan is using Aligned Elements to manage its Design History Files and have made extensive use of the capabilities offered by the product. In an effort to increase productivity, Tecan has decided to use Aligned Elements' Electronic Signatures to speed up the sign-offs of a number of DHF relevant documents.
Jan Cart, System Engineer, "We have targeted a set of deliverables where we think electronic signing will increase our productivity substantially vis a vis relying on hand-written signatures. Since Aligned Elements offers this possibility, we are eager to see what it can do for us. We will soon have 16 R&D team members equipped with electronic certificates for a pilot project. Hopefully we will see the results pretty soon."
Mario Billia, Risk Manager R&D, claims: "FDA has clearly pointed out that it endorses DHF's being submitted in electronic format and it further supports this path by explicitly accepting electronic signature based on the X509 V3 standard. I am of the opinion that the acceptance by FDA allows us to further explore these opportunities and find out how they can increase our own productivity."
The SiLA consortium for Standardization in Lab Automation chooses Aligned Elements
May 2009
The SiLA consortium, consisting of leading manufacturers, software suppliers, system integrators and pharma/biotech corporations, develops a new interface standard for rapid integration of lab automation systems. System procurers of lab automation systems, integrators and device suppliers shall all benefit alike from a common standard for device control and data interchange. Members of the consortium include Novartis Pharma, Roche, Actelion, Tecan, Hamilton, Perkin Elmer, Agilent Technologies and Thermo Fisher.
SiLA has chosen Aligned Elements for documenting, managing and monitoring the SiLA Interface Standard Requirements and Specifications.
More information about SiLA can be found at www.sila.coop.
Qiagen Instruments uses Aligned Elements with Citrix for flexible multi-site access
May 2009
Qiagen Instruments is a multinational actor in the sample and assay technology industry with a large multi-site R&D organization. Qiagen applies Aligned Elements for DHF Management and a significant part of the Project R&D team is constantly involved in the ongoing DHF activities.
"With our Team residing on two different physical sites (one in Germany and one in Switzerland), we had a situation where the performance of Aligned Elements was impaired from our current IT infrastructure. The data transfer capacity between the two sites did not correspond to our new needs and we had to do something to improve the performance." says Mr Roger Hueppi, Project Manager.
"We decided to place Aligned Elements in our existing Citrix environment and see what happened. The performance improvemed strongly. Operations that previously took minutes now occur within seconds.Our productivity has improved accordingly.", continues Mr Hueppi.
"As a further benefit, the Aligned Elements client is also available over our Citrix Web Interface which makes it possible for external team members to access our DHFs."
"Since we have trained over 50 users on Aligned Elements there were a considerable number of Aligned Elements client installations to maintain. With our migration to Citrix, a significant maintenance reduction could be achieved for the two local IT teams.", Mr. Hueppi claims. "Right now, we see only advantages with this approach."
Aligned releases Aligned Elements V1.6 Service Pack 1
Apr 2009
Aligned released Service Pack 1 for V1.6 on April 6th. This Service pack focus on performance improvements and closes a number of open defects reported for V1.6.
Aligned publishes preconfigured DHF content for Aligned Elements
Mar 2009
Aligned Elements presents an array of free downloadable content for Aligned Elements V1.6.
The preconfigured content which includes UserGroups, Queries and Export Transformations, can be imported in any Aligned Elements V1.6 client. See more information [here].
"We hope that this content will give our users and customers a valuable head-start when it comes to using Aligned Eements for documenting their Medical Devices." - states Karl Larsson, Director of Marketing. "This content which can be donwloaded from our website, can be used instantly. No installation is needed."
Aligned Elements V1.6 released
Feb 2009
Aligned AG makes their DHF Management system “Aligned Elements” even more attractive for the Medical Device Industry. Aligned Elements is
a dedicated system for managing Design History Files to ensure exceptional transparency, consistency and control using a minimal effort.
Aligned Elements integrates the processing of Requirements, Specifications, Risks, Tests, Design Reviews and Defect Tracking with Traceability Management, automated Consistency Checks, bi-directional integration with Microsoft Word, Digital Signatures and much more.
“We have made Aligned Elements V1.6 even more attractive for the Medical Device industry by making Industry Regulations an integral part of the system. You can now check how well your DHF content matches the rules of given norms and regulations. Furthermore, we have managed to seamlessly integrate Defect Tracking Items from external systems such as Altassian’s “Jira” and the Open Source System “Trac”. These Items can now be managed and traced from within the Aligned Elements Client.
REMP has chosen Aligned Element
Jan 2009
REMP develops and produces devices, consumables, software and fully automated sample processing and storage systems mainly used in
Research and Development by the world's leading pharmaceutical and agrochemical companies.
REMP products include systems and services, workstations, consumables and software applications for sample storage and retrieval, cherry-picking, climate control down to −80° C, plate replication and reformatting, powder dosing, vial weighing, tube capping and uncapping, thermal sealing, and piercing.
Since the beginning of 2009, REMP has decided to use Aligned Elements for their Design History File Management.
Qiagen Instruments goes with Aligned Elements for DHF Management
Dec 2008
Qiagen (NASDAQ: QGEN), a global leader in sample and assay technologies, has chosen Aligned Element to assist their Design History File Management process.
Qiagen provides hundreds of high quality products accorss a range of markets including Life Science, Pharma, Applied Testing and Diagnostics.
This multi-million dollar corporation develops highly complex products, bringing together expert competencies in chemical assays, modulare hardware, software, consumables and process integration. With over 34 multinational sites, the coordination effort of DHF's is going to be supported by Aligned Elements keeping several thousands of items under design control.