Quality at Heart
The Nantes University Hospital in France, the Instituto Nacional de Cardiologia in Rio de Janeiro/Brazil, and the Silesian Center for Heart Diseases in Zabrze/Poland have all been partner institutes of Berlin Heart GmbH since 2011. Within the course of cardiac patient treatment, these institutes are each able to implant Berlin Heart artificial hearts. These cardiac support systems take over the heart’s pumping function for patients who suffer from severe heart failure.
These artificial hearts are generally used to bridge the waiting period until a suitable donor heart is available. Donor hearts are in short supply everywhere in the world and the waiting periods are usually very long. Artificial hearts allow patients to lead almost normal lives for many years. Two different types of support system are in use – internal and external. These are either implanted directly into the chest or are carried externally and connected to the heart via tubes. The EXCOR®-System was designed to assist younger patients. Little Miriam, for example, received treatment with this support system at the age of one – all the way until a suitable donor heart was eventually made available.
FDA-Approval Endorsed Unanimously
July 2011 marked an important milestone for Berlin Heart. The advisory council of the US Food and Drug Administration (FDA) unanimously agreed that the EXCOR® Pediatric cardiac support systems be approved for use in the USA. Berlin Heart had laid its trust in CAQ AG Factory Systems (CAQ AG) in order to be able to convince the FDA of the high standards of quality employed in its products and processes. Alexander Blueschke, the head of IT at Berlin Heart, is convinced that “Approval for use in the USA would not have been possible without the implementation of a consistent CAQ-System”.
After, in 2008, the unrestricted IDE approval for the EXCOR® Pediatric had been granted in the USA, the company one year later decided to implement an integrated quality management system by CAQ AG. Day-to-day work with the CAQ system soon became second nature and, only two years after implementation, the FDA granted its approval for EXCOR® Pediatric.
Validated Quality Management in the Medical Sector
One of the criteria that the successful CAQ supplier needed to fulfil was extensive and longstanding experience in the area of medical technology. CAQ AG was able to offer precisely that, and more. The CAQ AG systems are certified and validated for use in the USA and fulfil all the required standards (e.g. FDA 21 CFR Part 11). This was the major prerequisite for successfully seeking the approval required for being allowed to distribute the artificial hearts in the US-American market.
Prior to Berlin Heart’s final decision regarding a suitable software supplier, they conducted a comprehensive audit of CAQ AG. Berlin Heart was able to convince itself first hand, that CAQ AG not only supplied state-of-the-art quality management systems, but in fact lived and breathed quality management in its own company. The fact that the CAQ software fulfilled the necessary requirements for the area of medical technology had already been proven via the validation with certificate of suitability earlier on.
Berlin Heart decided not to just gradually expand the CAQ system step by step, but to run it as all-encompassing solution from the beginning on. The new system was to replace the existing isolated applications and unite all required applications in one management system. The modular structure of the software allowed Berlin Heart to compile one tailor-made solution that covered all its core processes. This included production accompanying quality management from goods entry via production to outgoing goods inspections. Preventive maintenance, complaint management with CAPA and the standard-compliant control of all quality related documents thereby all became part of the one consistent solution.
A Fully Validatable System
The audit showed that CAQ AG offered a fully validatable system that had been tried and tested – and proven to exceed all expectations. Now the system needed to be introduced and validated onsite at Berlin Heart. Here Berlin Heart was able to count on the support of a partner of CAQ AG with years of experience in matters regarding compliance. This partner was devoted to the qualification/validation of IT systems and had successfully assisted many companies from within the area of medical technology prepare themselves for FDA certification procedures in the past. This allowed Berlin Heart to concentrate on its strengths and processes and utilize its resources effectively. It was thereby able to rapidly and purposefully achieve certification by the FDA.
Complete Traceability in proALPHA
One of the standard software modules that CAQ AG provides is a default interface that connects with all established ERP systems. It only needs to be parameterized once when it is implemented. For the proALPHA ERP system that Berlin Heart uses, CAQ AG offers a certified interface that was enhanced to include a variety of functions specifically for Berlin Heart. Functions that were already part of the interface included the synchronization of master data and the generation of inspection orders from within the ERP system. Additionally, the known batch information for each production order was now exported to the applicable inspection order. This means that all the inspector needs to do is confirm via mouse-click, e.g. that the planned screw was used in the relevant production step. If, for example, a part from an unplanned batch happens to be used in a process, then the CAQ system will, of course, directly report this back as well.
This ensures that the batch information for each individual part of every article is consistently available in both the ERP and CAQ management systems and can be traced comfortably. Searching in orders or larger tables, or needing to ask other departments in the company for information are a thing of the past. The quality managers responsible know that they can extensively answer any quality-related question in next to no time.
Fully integrated Systems during and after Updates
Both management systems (CAQ and ERP) remain fully integrated – even if one of the two undergoes an update procedure. Even if the database structures are changed within the framework of an update, the compatibility and integration of the two systems remains secured.
In order to be able to check new features that are included in a new release, the IT team of Berlin Heart extensively tests every update prior to applying it to the actual production system. They use the so-called ‘sandbox’ for this purpose. The ‘sandbox’ is a test environment which operates outside of the actual production system. All updates so far have been tested intensively and been deemed fully satisfactory. Hence, the IT team at Berlin Heart has always been able to rapidly distribute the updates to the individual workstations.
To ensure that the software tests are as efficient as possible, the IT team at Berlin Heart received comprehensive support via CAQ AG’s Support and Update Information System “SUI”. This online portal for CAQ AG’s customers features all changes made to the CAQ software within individual updates or release changes. Apart from providing effective assistance to CAQ AG customers, this complete documentation of the programming history is a necessary prerequisite for being able to validate a CAQ system.
The standard module AuditTrail.Net was also very helpful in fulfilling FDA guidelines. It keeps track of every individual record or field change and stores this information in a separate, highly protected data structure. Date, time, user, workstation, and changes made are all saved in a logbook. This means that no change is left unnoticed – be it the entry of inspection results, changes made to a library, or determining corrective and preventive actions.
AuditTrail.Net allows Berlin Heart to fulfill the requirements laid out by the regulating authorities, that govern, how data is to be stored in electronic format when IT systems are implemented to replace paper-based processes. In contrast to a simple logbook, the changes made are not only recorded, but can also be comfortably examined and evaluated – and all of this throughout the entire life-span of the CAQ system. Without this function, approval in the USA would not have been possible.
Controlled Complaint Management
Even though this was not a prerequisite featured in the demands of the standard, Berlin Heart also integrated its complaint management into the quality related document management system. Inbound and outbound complaints could now be controlled automatically via the document management system. After the reports are created, they are distributed directly to the persons responsible. Approvals may only be granted by the persons that are entitled to do so, and it is not possible to circumvent any of the process nodes that are put in place.
JobControl.Net automatically keeps track of the due date specified for the completion of each individual complaint. The central action and escalation management monitors the status of every complaint and reports back when an action is completed. If desired, it is also possible to specify that the persons responsible be notified via e-mail automatically of immanent and past due dates. It is even possible to specify that in certain, highly critical cases, the superior should be notified via e-mail if mails sent to a subordinate remain unanswered.
The standard form module Form.Net ensures that the reports created in the complaint management system precisely correspond to the prerequisites of Berlin Heart and its customers. This form generator allows free formatting of any number of report templates. If the default, standard-compliant forms included do not suffice, they can, of course, be altered to meet individual requirements. It is also possible to devise completely new reports, access all relevant database fields directly in the form, and even include photographs or drawings. Form.Net makes manually creating or supplementing complaint reports a thing of the past.
In the two years since the introduction of the CAQ system, Berlin Heart’s quality manager Alexander Blueschke has been able to convince himself first hand of the performance and reliability that the software has to offer. He therefore feels well-equipped for the full-scale launch of Berlin Heart’s products in the US-American market, and is looking forward to the further expansion of the CAQ system in light of the increase in production output that is expected.