Healthcare and pharmaceuticals
Critical to a successful health service is the transfer of knowledge and skills. But this can only be achieved through the effective capturing and sharing of Standard Operating Procedures (SOPs) and protocols through a proven document management system.
Managing document distribution, as well as approvals, versions and changes, is vital as the cost of failure is invariably measured in both human and financial terms. And it’s here that EQMS can revolutionise how safely and securely your organisation operates, minimising the risk of patient harm.
What EQMS can do for your organisation
We understand that your organisation is increasingly facing pressure to comply with regulation and an expanding range of standards as the industry looks to ensure patient safety with secure and proven processes.
From pharmaceutical and medical device manufacturers looking to comply with of FDA CFR 21 Part 11 and GMP, laboratories facing the demands of ISO/IEC 17025, ISO 15189 and standards such as Clinical Pathology Accreditation, to providers of social care fighting with Care Quality Commission registration the challenges facing organisations are vast.
UK & EU Regulations for quality and safety standards for the handling of human tissues and cells, require all such establishments be inspected and accredited by the Human Fertilisation and Embryology Authority (HFEA). Accreditation is entirely dependent on there being evidence of robust processes and high standards of clinical governance.
In the UK the MHRA have regulatory powers over pharmacies, blood services and many aspects of clinical governance. The MHRA enforces GMP and ICHQ 10 in pharmacies and the Blood Safety and Quality Directive for blood services. Equivalent regulatory bodies such as the FDA in the US enforces similar regulations and organisations such as the AABB manage a rigorous accreditation processes.
As well as an obvious obligation to assure patient safety, the health professional is also faced with an increasingly litigious public, confident of its rights and enthusiastically supported by the legal profession. Non-compliance with regulatory demands and even a lack of evidence of due process puts not only the patient at risk but the health professional’s career and livelihood in danger too.
Our strong track record of working within the healthcare and pharmaceutical sector has shown that EQMS can help your organisation to:
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Reduce the risk of human error
Providing controlled distribution of and access to Standard Operating Procedures (SOPs) and other documentation which helps minimise the potential for human error -
Reduce the burden on resources
Dramatically reducing the cost and effort required to comply with multiple standards and regulations and reduce the administration burden -
Ensure compliance
Automatically manage processes and generate records that provide evidence of compliance and underpin Clinical Governance -
Assist manufacturers
EQMS assists the manufacturers of healthcare products in complying with cGMP, assuring consistent product quality and speeding up the process of bringing new products to market
Who uses EQMS
EQMS is in use extensively across the NHS at numerous NHSTrusts and in a variety of disciplines. Leeds Teaching Hospitals NHS Trust, 2Care, the Northern Institute of Genetics and the Yorkshire Bone Marrow Transplant Unit are just a few examples of organisations that have adopted EQMS to drive the pursuit of quality.
What is EQMS?
EQMS is the proven compliance management system that makes your organisation more agile and productive.
Contact us
Drop us a line with any questions you might have about the EQMS system and the ways it can help your organisation.
How our customers use EQMS
- The Directorate of Pathology required a single Quality Management System that could be deployed across all departments to reduce duplication, and ensure that all Pathology disciplines managed their documentation in a consistent, integrated manner.
- Read more about how Leeds Teaching Hospitals uses EQMS
- 2Care required an electronic Quality Management solution to reduce the duplication of documentation and speed up communication between themselves and the residential care projects they managed.
- Read more about how 2Care uses EQMS
Unrivalled support
Our expert support team works with you every step of the way to ensure that you get the most from EQMS by placing it at the heart of your business.
