The College of American Pathologists (CAP), Clinical Pathology Accreditation (CPA), Medicines and Healthcare Products Regulatory Agency (MHRA) and the Food and Drug Administration (FDA) are committed to ensuring quality and best practice is maintained to a high level. Compliance with ISO 15189 demands commitment to operational excellence and this places a burden of work on the laboratory.
The historic management approach of fragmented systems, paper and manual processes, electronic documents, spreadsheets and email is inadequate and creates a crippling bureaucratic burden.
- Audits must be carried out to ensure these procedures followed, staﬀ can easily report problems.
- Assets must calibrated and maintained with an audit trail.
- Suppliers must be audited to ensure their products and Services are of the necessary standard.
- Risks must be identiﬁed and treated.
- Staﬀ must be shown to be competent.
Q-Pulse, from Ideagen, is a fully integrated Electronic Quality Management Solution (eQMS) that helps laboratories transform their operational processes and substantially decrease the time spent on compliance activities.
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