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Resources

Product Information

Why TestStream®? (high res)

TestStream for Cerner Millennium® (high res or low res)

TestStream for Millennium CPOE (low res)

TestStream for Epic Hyperspace (high res)

TestStream for McKesson Horizon® (high res or low res)

TestStream Donor Validation Suite (high res or low res)

TestStream Scenario Definition System (high res or low res)

Blood Bank Validation for Millennium (high res or low res)

Lab and Blood Bank Validation for Sunquest® (low res)

Vedant Legacy Testing Products

Whitepapers

CIO Strategy: Automated Testing for HIS

Regulations and Compliance

ARRA/HITECH Act

HIPAA

EHR and Meaningful Use

Incentive Program for Electronic Health Records

Standards and Certification Criteria for Electronic Health Records

FDA

General Principles of Software Validation; Final Guidance for Industry and FDA Staff (CDRH, January 11, 2002; UCM085371)

Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices (September 9, 1999; UCM73779)

Guidance for Industry Process Validation: General Principles and Practices (January 2011, Revision 1; UCM070336)

AABB

Standards for Blood Banks and Transfusion Services

ISBT

ISBT Guidelines for Validation of Automated Systems in Blood Establishments

ICD-10

International Statistical Classification of Diseases and Related Health Problems 10th Revision

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