Design and development validation: Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. Design validation shall be performed under defined operating conditions on initial production units, lots, or batches or their equivalence. Design v ...

Data management (a) Procedures used for data review, database cleaning, and issuing and resolving data queries. (b) Procedures for verification, validation and securing of electronic clinical data systems, if applicable. (c) Procedures for data retention. (d) Specified retention period. (e) Other aspects of clinical quality assurance, as appropriate. 1.9 Amendments to the clinical investigation pl ...