Orthoplastics meet US and European regulatory requirements with Q-Pulse

With manufacturers under increasing scrutiny by regulators, Orthoplastics maintain Quality and Environmental Management Systems (QEMS) that are certified to ISO 9001, ISO 13485, ISO 17025, ISO 14001 and OHSAS 18001, as well as the FDA’s 21 CFR Part 820 and the EU’s 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.

Ideagen provided Orthoplastics with a compliance management solution to help manage and reorganise their compliance activities via electronic document control, auditing, and CA/PA management.

Benefits

• Working with a centralised system for all internal and external QEMS documents – including SOPs, work instructions, customer specifications, procedures and legislation
• Significantly reduced document management processes
• All documents, auditing and CAPA activities interlinked to provide greater visibility
• Reduced risk of staff overlooking actions, which has accelerated time to completion
• Increased availability of QEMS information to all areas and all levels of the business
• Security requirements met as only documents relevant to role and seniority can be accessed
• Ability to demonstrate compliance on demand for authorities, regulatory bodies and customers