UK-based Orthoplastics Ltd manufacture and supply medical grade UHMW-PE material to the orthopaedic implant market. Orthoplastics also sub-contract the manufacture of component parts for orthopaedic implant
manufacturers for assembly into the finished implantable device.

Q-Pulse provides medical device manufacturers and their suppliers with a compliance management solution that helps manage processes including Document Control, Auditing, and CA/PA Management, in regulatory environments such as 21 CFR Parts 11 and 820 and the European Medical Device Directive.

From internal and external audits of the company and its suppliers, to third-party audits by customers and regulatory bodies, systems at Orthoplastics are constantly under scrutiny. In maintaining and improving their regulatory compliance, they chose Q-Pulse from Gael Ltd.

‘In the medical device industry, regulatory bodies in the US and EU are increasingly emphasising the need to address non-conformances and customer complaints at each stage of the manufacturing process,’ explains Mark Day, Quality Manager at Orthoplastics.

‘As with any sub-contractor business, the customer is of the utmost importance to us. We have procedures, quality agreements, product specifications and drawings for each customer, as well as for each product range.

‘In reviewing a range of software solutions, it was important to consider factors such as functionality, user-friendliness and cost-effectiveness. We needed a platform that offered a control system that was easy to use and provided good traceability, particularly with relation to the status of CA/PAs and Audits.’

With manufacturers under increasing scrutiny by regulators, Orthoplastics maintain Quality and Environmental Management Systems (QEMS) that are certified to ISO 9001, ISO 13485 and ISO 14001.

As a critical supplier to several manufacturers, Orthoplastics needed a solution that would also help them to meet their customers’ needs in allowing them to comply with the industry requirements demanded by both the FDA’s 21 CFR Part 820 and the EU’s Medical Device Directive.

Key benefits of using Q-Pulse at Orthoplastics include:

• Accessibility to a selection of data sources for multiple users
• Ability to provide supporting data for Audits and CA/PAs at the push of a button
• All critical functions are available and interlinked allowing greater visibility of the QEMS achieving compliance with ISO 13485 case study 3

‘The system’s initial benefit to us was in managing Document Control activities and recording CA/PAs, where Q-Pulse allowed us to attach relevant supporting evidence to each record,’ says Mark. ‘To begin with, we used Q-Pulse to control all internal QEMS documents, including SOP, work instructions and forms.

‘We were then able to expand its use to include externally controlled documents such as customer specifications and procedures, legislation etc. Q-Pulse has helped us to reduce the time and effort spent throughout the document management process, and we now spend significantly less time and effort in copying, stamping, filing etc.

‘With access to a selection of data sources for multiple users, we’ve also been able to increase the availability of QEMS information in all areas and at all levels of the organisation. Appropriate security ensures that users can view only the records and documents relevant to their role and responsibility.

‘Increasing industry emphasis on addressing complaints and non-conformances has meant that Q-Pulse’s CA/PA functionality has been a real boon for us. The flexibility to customise CA/PA templates with additional stages, eg review and containment has given us powerful tools to meet these requirements.