CryoConcepts is a company that manufactures cryosurgical devices under the guidance of FDA and ISO regulations for use by health care professionals. Because of the company structure where employees are decentralized with some located in other countries, a brick and mortar approach to the Quality System Documentation Control would have been difficult to implement and maintain. With that in mind, an internet-based cloud approach to a shared system was adopted early as one of the company’s philosophies.
The Document Control Module is a perfect fit for ours needs. Early in the life of CryoConcepts, we implemented the Document Control Module to support the structure for our Quality Management System. It houses our quality system documents and design files.
We make extensive use of the change control and revision tracking capabilities already built into the system. Use of the Document Control Module has streamlined our document assessment, approval and publication processes providing our employees secure access over the internet enabling us to put the most current documents into effect quickly and efficiently.
Another valuable aspect of the Document Control Module is that a computer with internet access is all that is needed to implement and access the system. BizzMine takes care of the rest. We did not have the upfront capital costs of hardware (servers, routers, etc) nor software. We’ve also saved on personnel costs by teaming with BizzMine. They take care of the day-to-day tasks of help desk, system maintenance, backups, disaster recovery preparedness, etc.
As an early stage company, our employees wear multiple hats.
Having BizzMine provide support for the Quality System infrastructure has freed us up to concentrate on growing the business.
Larry Fishler, Director of Operations
The production and it’s facilities need to comply to high standards from legislation on pharmaceuticals productions. Within the quality system CAPA-management (corrective action and preventive action), Complaints and Management of Change (MoC) are important processes that have to fulfill to GMP, ISO and FDA requirements.
These processes have been executed in a paper-based system. With the BizzMine workflow module the CAPA and MoC processes have been made ‘paperless’ and is compliant to the requirements of 21 CFR Part 11 (Electronic Records; Electronic Signatures).
It has been proved that both the software and the customized applications are able to be qualified for use in a pharmaceuticals environment.
With a good preparation on the design of the forms and workflows, BizzMine was able to implement both CAPA and MoC application within two days.
The necessary but limited need of support after the Implementation responded to quickly and excellent by BizzMine. The workflow module has reduced the workload and risks on important regulatory aspects.
Jeroen de Jong, Manager QHSE
In 2020 Laurastar celebrates its 40th anniversary with the relocation of the international headquarters to a new building and the opening of a new factory.
Laurastar is the leading brand in professional ironing systems committed for textile care and against planned obsolescence. A permanent requirement of very high quality, precision and aesthetics making this Swiss know-how a world reference.
Laurastar trusts BizzMine for document management and quality.
After an evaluation of BizzMine, Bpm’online and MS SharePoint, Laurastar opted to implement BizzMine, the new software of a stable company with 25 years of experience, for its management of documents and processes related to quality certification.
We visited Laurastar’s global headquarters to ask the Quality and IT manager about their experience with BizzMine.
“Initially, Laurastar mainly needed and electronic solution to manage all procedures and instructions for ISO certification. Using BizzMine we have found that it is also the perfect tool for our internal audits. For example, we have created solutions in BizzMine for our supplier entry controls.”
The installation and implementation of the first processes went very quickly.
“The installation and implementation of the first processes went very quickly. Being able to work with the system within a few days convinced everyone. In BizzMine users know exactly how to create and adapt the processes themselves, without any programming knowledge. BizzMine is a user-friendly and powerful solution.” As an expert in user experience, at Laurastar they know perfectly what an intelligent product is.
To the question if it would be interesting to manage calibration in BizzMine, the answer was “so much the better if it is possible.”
Laurastar is also very satisfied with the service provided: training, support… everything is running efficiently and quickly, and this help is clearly a valuable asset.
Alexandra Vlachou, Quality Manager