Quality Assurance

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Express Diagnostics has consistently implemented and supported the most effective and up-to-date quality control and auditing systems possible. Our approach to quality is encompassed by two systems, ISO 9001:2000 and Good Clinical Practice (GCP).

The International Organisation for Standardization (ISO) 9000 is a series of international standards, it may be fair to claim that they are the most influential and successful standards ever devised. They are viewed as a framework for good management across the whole of a business.

GCP Quality Assurance ukas Quality Assurance

This series of standards result from an extensive consultation process and have been carefully drafted to offer a whole range of benefits. Description of the process of implementation to a modernised and enlarged framework that reflects the latest management thinking and takes full account of a wealth of solid, practical experience of ISO 9000 systems. Express Diagnostics holds ISO9000 accreditation with the British Standards Institute.

What is ISO9000 accreditation?

ISO 9000 is the internationally recognised standard for an organisation’s internal Quality Management. The term ‘quality’ refers to all those features of a product or service which are required by the customer. An organisation’s ‘Quality Management’ refers to an organisation’s actions to ensure that its products or services satisfy its customers’ quality requirements and complies with any regulations applicable to those products or services.

What is Good Clinical Practice (GCP)?

Definition from EU Directive 2001/20/EC, article 1, clause 2:

Good clinical practice is a set of internationally recognised ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.

Express Diagnostics follows strict regulatory guidelines ensuring the consistently highest quality data possible. Our quality control processes are continually updated to the ever changing requirements and regulations within the pharmaceutical industry. Quality checks are consistent throughout processing of data from receipt to delivery of data to the client or sponsor and until the final database lock.

At Express Diagnostics we use a quality management system that uses regulatory-compliant standard operating procedures. With regular internal process audits and client audits/evaluations conducted to ensure the effectiveness of our quality management system and SOP adherence. All of our standard operating procedures as well as our computer systems are validated and maintained under a controlled change system until no longer required or obsolete.