T/SHSPTA 001-2024 Computer Information System Evaluation Standards for Medical Device Business Enterprises

Scope

Scope: This document specifies the requirements, evaluation rules, and evaluation methods for the functional, operational, judgment, control, network, and computer hardware and software environments of computer information systems in medical device operating enterprises. This document is applicable to the development, selection, third-party agency evaluation, and supervision and inspection by regulatory authorities of computer information systems in medical device operating enterprises. Main technical content: 4. Computer system essential functions, logical connections, judgment and control 4.1 Setting and assigning operating permissions 4.2 Process and control of first-time business review 4.3 Content of first-time business information for products, suppliers, and purchasers in the system 4.4 Setting and control of business scope 4.5 Automatic early warning and control of system expiration dates 4.6 Creation, adjustment, and linkage of business databases 4.7 Management of quality-related data, reports, records, and business invoices 4.8 Quality control of problematic products 4.9 Direct distribution management of medical devices 4.10 Unique identification management of medical devices 4.11 Function of data interaction interface with external business and regulatory systems 4.12 Management of system time and operation logs 4.13 Data security backup and retrieval 5. Requirements for network and computer hardware and software environments 5.1 Network environment requirements 5.2 Computer hardware and software environment requirements 6. System compliance evaluation 6.1 Explanation of the Computer Information System Evaluation Form 6.2 Applicable entities and evaluation methods 6.3 Evaluation conclusions 6.4 Continuous improvement Appendix A (Normative) Requirements for computer information system quality management records and fields Appendix B (Informative) Computer Information System Evaluation Form

Development Information

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