Standards
With public concerns increasing around the quality of services within healthcare, both nationally and internationally, regulatory bodies have been given an increased requirement to ensure these services meet the required criteria.
With modules to effectively manage Documents, CA/PA, Audit, Suppliers, Assets and Staff Competencies, Q-Pulse can help ensure requirements for each regulation and standard are met effectively.
Nationally and internationally, and across multiple sectors within the healthcare marketplace, Q-Pulse has been used to assist organisations in meeting regulations and standards including:
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21 CFR Part 606
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42 CFR Part 121
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American Association of Blood Banks (AABB)
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Association of Organ Procurement Organizations (AOPO)
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American Association of Tissue Banks (AATB)
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Care Quality Commission (CQC)
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Clinical Pathology Accreditation (CPA)
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College of American Pathologists (CAP)
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EU-Blood Safety Directive
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Foundation for the Accreditation of Cellular Therapy (FACT)
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Good Clinical Practice (GCP)
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Good Laboratory Practice (GLP)/ 21 CFR Part 1271
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Good Manufacturing Practice (GMP)/ 21CFR Part 210 and 210
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Human Tissue Authority (HTA)
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Human Fertilisation and Embryology Authority (HFEA)
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Ionising Radiation (Medical Exposure) Regulations 2000 (IR(ME)R )
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ISO 9001
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ISO 15189
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ISO 17025
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Joint Accreditation Committee ISCT EBMT (JACIE)
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Medicines and Healthcare products Regulatory Agency (MHRA)
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National Association of Testing Authorities (NATA)
Gael’s Q-Pulse solution also offers optional EU-GMP Annex 11/ FDA 21 CFR Part 11 capabilities to provide the correct controls to organisations having to meet GMP requirements.
In addition to this, Gael also offers a Validation Support Service to assist organisations in developing their Q-Pulse validation documentation.
By providing a flexible solution, Q-Pulse can be adapted to meet any number of the above standards and regulations, simultaneously ensuring that your solution can change as your compliance and regulatory requirements change.