Ensuring the Integrity of Electronic Health Records

<p>Data integrity is a critical aspect to the design implementation and usage of any system which stores processes or retrieves data. The overall intent of any data integrity technique is the same: ensure data is recorded exactly as intended and upon later retrieval ensure the data is the same as it was when originally recorded. Any alternation to the data is then traced to the person who made the modification. The integrity of data in a patient’s electronic health record is critical to ensuring the safety of the patient. </p><p>This book is relevant to production systems and quality control systems associated with the manufacture of pharmaceuticals and medical device products and updates the practical information to enable better understanding of the controls applicable to e-records. The book highlights the e-records suitability implementation and associated risk-assessed controls and e-records handling. The book also provides updated regulatory standards from global regulatory organizations such as MHRA Medicines and Healthcare Products Regulatory Agency (UK); FDA Food and Drug Administration (US); National Medical Products Association (China); TGA Therapeutic Goods Administration (Australia); SIMGP Russia State Institute of Medicines and Good Practices; and the World Health Organization to name a few.</p>