SmartScan meets or exceeds the guidance published in FDA 21 CFR Part 11 which covers the security (preventing change) of data stored in electronic form and electronic signatures.
SmartScan also meets or exceeds the cleanroom environmental monitoring requirements published by U.S. Pharmacopeia in USP. This document sets practice standards to help ensure that compounded sterile preparations are of high quality and that the preparation process is safe.
ISO 14644 has replaced the old FED-STD-209E that specified the classification of air cleanliness of cleanrooms in terms of concentration of airborne particles. SmartScan provides the facilities to allow users to meet the requirements of the new standard in a variety of ways, mainly the ability to automatically adjust the monitoring point limits based on the operational condition of the cleanroom (“in operation” or “at rest”).
SmartScan meets or exceeds the monitoring requirements of the following Healthcare Accreditation Agencies based in the United States.
- Healthcare Facilities Accreditation Program (HFAP)
- Joint Commission (JC)
- Community Health Accreditation Program (CHAP)
- Accreditation Commission for Health Care Inc. (ACHC)
- The Compliance Team: “Exemplary Provider Programs”
- Healthcare Quality Association on Accreditation (HQAA)
- DNV Healthcare Inc.
Also, SmartScan meets or exceeds the monitoring requirements of the following Laboratory Accreditation Agencies.
- College of American Pathologists (CAP)
- National Accrediting Agency for Clinical Laboratory Sciences (NAACLS)
- American Association for Lab Accreditation (A2LA)
- ANSI-ASQ National Accreditation Board (ANAB)
- International Accreditation Service, Inc. (IAS)
- National Voluntary Laboratory Accreditation Program (NVLAP)
- Laboratory Accreditation Bureau (L-A-B)
- Perry Johnson Laboratory Accreditation, Inc. (PJLA)
Blood Banks come under FDA scrutiny as well as the following Blood Bank Accreditation Agencies. SmartScan meets or exceeds the online monitoring requirements of each.
- American Association of Blood Banks (AABB)
- Foundation for the Accreditation of Cellular Therapy (FACT)
Although it has not been studied in detail, SmartScan probably meets the online monitoring requirements of the following International Healthcare Accreditation Agencies.
- Malaysian Society for Quality in Health, or MSQH – based in Malaysia
- QHA Trent Accreditation – based in the UK-Europe
- Australian Council for Healthcare Standards International, or ACHSI – based in Australia
- Accreditation Canada – based in Canada
- Thailand Hospital HA – based in Bangkok, Thailand
- Taiwan Joint Commission on Hospital Accreditation – based in Taipei, Taiwan
- La Haute Autorité de Santé, French National Authority for Health, based in Paris, France
- DNV Healthcare – based in Norway and the USA