For most medical device manufacturers, the roadmap to market will start with ISO 13485:2016 certification. Obtaining an ISO 13485:2016 certificate is evidence that the Quality Management System in place is compliant with international standards and is a key component of a registration package with the regulators.
This article was originally published by SeerPharma's business partner MasterControl and is republished in-part here with their permission.
Research and operations of Medical Technology, Biotechnology and Pharmaceutical (MTP) companies aligned with and in some cases certified to Quality Management System (QMS) Standards will ensure Australia is at the forefront of medical innovation.
MTPConnect is a not-for-profit organisation, established by the Australian Federal Government’s Industry Growth Initiative. MTPConnect’s aim is to accelerate the rate of growth of the medical technologies, biotechnologies and pharmaceuticals (MTP) sector to increase commercialisation, collaboration and establish Australia as an Asia-Pacific hub...
“Our goal is to determine if the firm’s manufacturing operations are in a state of control. The CGMPs are a management-based regulatory approach. We do not specify how a company must structure its quality system. The regulations provide general expectations and we let the firm’s management structure its GMP compliance program accordingly. A GMP...
The Corrective and Preventative Action (CAPA) system is central to every Quality Management System (QMS). Quality professionals know the importance of managing CAPAs when a quality event occurs.
How SeerPharma worked closely with a leading Australian manufacturer in Tasmania to automate its material management processes.
A major sponsor and distributor of medical devices in Australia engaged SeerPharma to conduct a gap assessment of it’s Quality Management System and Operations against ISO 13485:2016. The client's current operations are licensed to ISO 9001:2015 and required assistance from SeerPharma to understand what would be required to upgrade their QMS to...
SeerPharma has over 25 years of experience implementing electronic Quality Management System (eQMS) solutions for companies operating in regulated environments. With extensive experience in the industry, we are excited to announce that we have now signed on to become a Partner for MasterControl.
SeerPharma’s Software Solutions team has been engaged to implement an electronic Quality Management System (eQMS) for a major multinational pharmaceutical company.
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