By Charlotte Plestant (Scientific Content Manager), Shanyate Simonin (QARA Manager) - 31 Aug 2021
Since Shanyate Simonin has joined Keen Eye, she has at heart to guide the integration of AI within highly regulated environments such as the Life Sciences. “Quality assurance is the keystone of a company's compliance to regulatory requirements”, declares Shanyate. “Its role is to prevent any flaw throughout the patient care process”. In that context, a range of systematic activities needs to be processed in order to ensure the quality, integrity and reliability of information used for the purpose of patient care.
A Quality Management System (QMS) demonstrates a company’s ability to meet its applicable customer and regulatory requirements. Regardless of the company size, the essence of such a QMS across the patient and clinical trial subject care process, relies on several important objectives. These include supporting compliance to regulations and standards in vigor while ensuring the quality of the products and services that are provided, along with their efficacy. The latter implies that all the produced data are reliable.
The Life Science industry is constantly changing. Quality assurance is highly impacted since digital transformation is not only about software, but also about data management, processes and people. One of the aspects brought by the technological changes is the multiplicity of stakeholders in the data management loop. This involves more complexity in the data management process, which highly affects data security. Quality brings a diverse range of benefits such as reliability, repeatability and risk control. These aspects are particularly important in Digital Pathology where the information needs to be accurate, timely, complete and secure to take care of patients or clinical trial subjects in the best possible way.
To achieve this ambition, the effectiveness of the Keen Eye QMS relies on all the teams that build the company. With experience in medical device software and pharmaceutical industry, the Quality and Regulatory team is made up of individuals from different backgrounds, with complementary skills in the pathology field.
A challenge in quality management is to develop a proactive quality culture within a company. This is a real opportunity to ensure processes are implemented efficiently, to create value from R&D phase to the release of products and services. From the very beginning of the Keen Eye adventure, delivering high-quality products in the most responsive way has been a non-negotiable priority. Keen Eye is ISO 13485 certified since March 2017, just two years after its creation, which demonstrates this natural dedication to quality.
Implementing an effective QMS requires the deployment of a centralised quality strategy. “Topics such as defining roles and responsibilities, procedures and processes, metrics, traceability, staff training and awareness programs are part of an efficient organisation that meet quality requirements”, describes Shanyate. To ensure the company strategy fits these quality requirements and to continuously improve the QMS, Keen Eye is subjected to regular audits.
Quality is mandatory. Its role within a company such as Keen Eye is to structure the organisation so as to satisfy the requirements of all stakeholders, whether they are internal, external or of a legal or regulatory nature.
Shanyate Simonin is a Quality engineer from INSA, France. She has worked for LASSE (Laser Systems & Solutions Of Europe) as a Quality and Certification engineer before moving to the Medical Devices field. Shanyate became a QARA officer at Evolucare Technologies, a healthcare IT company, where she managed the QMS and the Regulatory affairs for healthcare softwares including Medical Devices. She then worked for Mauna Kea technologies as a Regulatory affairs specialist in Medical devices and DPO (Data Protection Officer). With her background and strong quality expertise, she has joined Keen Eye as she believes that “Quality is crucial to safeguard patient and clinical trial subject safety, product quality and data integrity all together”.