ABSTRACT
This chapter covers the controls to e-records and associated data. The controls can be implemented on manual processes with paper records to the use of computer systems. The chapter analyzes and correlates, even the data and record controls in ISO/IEC 17025 are applicable to the laboratory environments, the controls and associated regulations using manufacturing-related regulations/guidance. The laboratory shall establish and maintain procedures for identification, collection, indexing, access, filing, storage, maintenance, and disposal of quality and technical records. Quality records shall include reports from internal audits and management reviews as well as records of corrective and preventive actions. All records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Retention times of records shall be established. Data integrity arrangements must ensure that the accuracy, content, and meaning of data is retained throughout the data life cycle.
