Regulation 32

maintain proper, complete and accurate records of every programme, policy, system, measure, protocol or process that the licensee is required to implement under these Regulations, and every activity undertaken under or change made to that programme, policy, system, measure, protocol or process;

maintain proper, complete and accurate records of each human tissue that is received by the licensee for processing, including the time at which the human tissue is received for processing;

maintain records of every approval given by a Clinical Governance Officer or any other suitably qualified personnel designated by a Clinical Governance Officer under these Regulations;

maintain records of every policy and procedure established by a Clinical Governance Officer under these Regulations; and

take reasonable steps to ensure the confidentiality, integrity and security of every record mentioned in sub‑paragraphs (b) and (c).

establish and implement a process to ensure there is proper document control of all documents relating to the human tissue banking service;

ensure that a Clinical Governance Officer approves, signs and dates each record mentioned in paragraph (1)(a); and

ensure that at least one personnel is responsible for the document control of all documents relating to the human tissue banking service.