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2. Computerized system validation - Wikipedia

   en.wikipedia.org/wiki/Computerized_system_validation

   The system lifecycle then enters the operational phase and continues until system retirement and retention of system data based on regulatory rules. Similarly, The Rules Governing Medicinal Products in the European Union, Volume 4, Annex 11: Computerised Systems applies to all forms of computerized systems used as part of a GMP regulated ...

3. Good automated manufacturing practice - Wikipedia

   en.wikipedia.org/wiki/Good_Automated...

   The most well-known is The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture. The second edition (GAMP5) was released in July 2022. [2] Other publications in the GAMP series include: GAMP Good Practice Guide: A Risk-Based Approach to Compliant GxP Computerized Systems

4. Health information management - Wikipedia

   en.wikipedia.org/wiki/Health_information_management

   Healthcare quality and safety require that the right information be available at the right time to support patient care and health system management decisions. Gaining consensus on essential data content and documentation standards is a necessary prerequisite for high-quality data in the interconnected healthcare system of the future.

5. Title 21 CFR Part 11 - Wikipedia

   en.wikipedia.org/wiki/Title_21_CFR_Part_11

   This guidance supersedes the guidance of the same name dated April 1999; and supplements the guidance for industry on Part 11, Electronic Records; Electronic Signatures — Scope and Application and the Agency's international harmonization efforts when applying these guidances to source data generated at clinical study sites.

6. Validation master plan - Wikipedia

   en.wikipedia.org/wiki/Validation_master_plan

   A VMP is the foundation for the validation program and should include process validation, facility and utility qualification and validation, equipment qualification, cleaning and computer validation. It is a key document in the GMP ( Good manufacturing practice ) regulated pharmaceutical industry as it drives a structured approach to validation ...

7. Health information technology - Wikipedia

   en.wikipedia.org/wiki/Health_information_technology

   Health information technology (HIT) is "the application of information processing involving both computer hardware and software that deals with the storage, retrieval, sharing, and use of health care information, health data, and knowledge for communication and decision making". [8]

8. Clinical data management - Wikipedia

   en.wikipedia.org/wiki/Clinical_data_management

   The data management plan describes the activities to be conducted in the course of processing data. Key topics to cover include the SOPs to be followed, the clinical data management system (CDMS) to be used, description of data sources, data handling processes, data transfer formats and process, and quality control procedure

9. Clinical decision support system - Wikipedia

   en.wikipedia.org/wiki/Clinical_decision_support...

   A Clinical Decision Support System (CDSS) is a computerized tool designed to assist healthcare providers in making clinical decisions by integrating medical knowledge with patient data. These systems utilize algorithms, databases, and patient information to provide tailored recommendations, alerts, and reminders to healthcare professionals at ...