Digital Health
The situation
A technology company was emerging into the life science space with a brand-new technology that could revolutionise accessing the right patients for the right trials. The company had little experience in the R&D side of pharmaceutical and device work, no quality organisation existed and little experience with the regulatory frameworks surrounding their offerings
The Solution
DQA provided senior executive level expertise to support the organisation, formulating a quality strategy, introducing the company to the regulations and guidance in the healthcare world, including a full suite of services for validation of their software solution.
Results
A fully compliant QMS, fully validated software solutions, meetings with leading healthcare authorities, allowing the company to place itself in the regulatory framework and to have ongoing contact with key regulators. This led to winning contracts with several key organisations in the pharmaceutical, device and contract research spaces.
DQA Advantage
Connectivity. DQA connected the company with key regulators, connected the products they had in the Artificial Intelligence World with real world scenarios, provided key advice on a ‘right sized’ QMS, and led the company through it’s first audits and assessments. A quality organisation was formalised within the company and DQA was retained to consult to the QA group post-adoption.
Healthcare
The Situation
A small biotech firm was in the process of submitting its first product for registration to worldwide regulatory agencies with limited knowledge of the regulatory aspects of technology surrounding their application, quality system and preparedness for inspection.
The Solution
DQA provided insight into the current regulatory frameworks, conducted on-site inspection preparation meetings. Assisted with the completion of inspection questionnaires and completed internal audits of key systems that were in scope of the submission
Results
The company successfully navigated their first submission, and their product is now approved for use. The areas of the company that were prepared and received an audit were ready to answer the questions from the regulatory agencies which they had been trained for.
DQA Advantage
Success. As the principal consultant had been through many inspections, and, had dealt with the unexpected results of inspections such as regulatory actions, the company that contracted with DQA had knowledge of all scenarios that could be expected, and could answer questions eloquently with the right amount of detail.
MEDICAL DEVICES
The Situation
An emerging technology company had a software as a medical device product, that had gone through the initial research. However, the company was technology based and did not have a regulatory organisation to guide them.
The Solution
DQA senior personnel mentored the CEO in the quality and regulatory standards expected to emerge into the market. A full dissection was conducted of Industry Standards (ISO/IEC), Regulations (Global and Country Specific) and Guidance for submission of the device to key regulatory authority review departments.
Results
The company has now conducted its first submission and is awaiting positive regulatory opinion. The journey the company has taken has embedded quality into its systems and given global awareness of the place of IT quality within the organisation, and its importance now and in the future.
DQA Advantage
Understanding. Total and unequivocal understanding of the regulatory frameworks, and the ‘how to’ approach of implementation. Making the client a success as central to our customer focus ethos.
VETERINARY
The Situation
The organisation wanted to perform GLP studies in non-commercial veterinary operating theatres with unvalidated equipment, and a lack of awareness of current regulatory guidance
The Solution
DQA put forward a team of experts who were able to diagnose the issues, produce a remediation plan and implement the solution, as a right first-time exercise so that the client could successfully take regulated work from a client.
Results
The organisation successfully ran the GLP studies in an environment that was compliant with GLP regulations and was advised on future advances for further compliance efforts, to ensure that they continued to work to GLP.
DQA Advantage
Adaption. DQA Experts were able to adapt to the non-commercial environment and ensured that they had the correct controls in place, for a right sized approach to validation, which encompassed GLP compliance, and remained on-call after the completion of the project to ensure that any questions or queries could be answered and challenges mitigated.