The manufacturer shall establish arrangements for these processes including, as applicable:— (a) defined criteria for review and approval of the processes; (b) approval of equipment and qualification of personnel; (c) use of specific methods and procedures; (d) requirements for records; and (e) revalidation. The manufacturer shall establish documented procedures for the validation of the applicati ...

7.5.1.1 General requirements The manufacturer shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable:— (a) the availability of information that describes the characteristics of the product; (b) the availability of documented procedures, documented requirements, work instructions; and reference materials and refere ...

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 ...