Archiving

This chapter discusses the importance of archiving the data. As well as regulatory advice the requirements of the most useful reference guide, ISO11799, is reviewed. Practical advice on issues such as location, storage, security, and environmental controls is given. The management of the archive from preparation to transfer of data is described. Methods of indexing and cataloguing together with tracking are detailed and systems for retrieval of data are explored. The role of the archivist in audits and inspections is discussed as the content of the TMF will be assessed during audit to ensure a clear audit trail is maintained. Retention times for essential documents are reviewed in the EU the regulation stipulates that data has to be kept for 25 years. As more and more information has to be archived the use of off-site or commercial archives is becoming more common and the additional requirements for a third party service provider are described. The introduction of eArchiving and the associated problems with long term storage of electronic data are discussed along with the various methods that may be used. The FDA issued guidance for electronic data and compliance with this guidance, CFR21 part 11, is vital. CFR 21 part 11 is widely followed within Europe and the standard is frequently referred to by the regulatory inspectors.