Article 9
Documentation 1. The manufacturer shall have a system of documentation based upon specifications, manufacturing formulae and processing and packaging instructions, procedures and records covering the different manufacturing operations that they perform. Documents shall be clear, free from errors and kept up to-date. Pre-established procedures for general manufacturing operations and conditions shall be available, together with specific documents for the manufacture of each batch. This set of documents shall make it possible to trace the history of the manufacture of each batch. The batch documentation shall be retained for at least one year after the expiry date of the batches to which it relates, or at least five years after the certification referred to in Article 30 (2) of Directive 81/851/EEC, whichever is the longer. 2. When electronic, photographic or other data processing systems are used instead of written documents, the manufacturer shall have validated the system by proving that the data will be appropriately stored during the anticipated period of storage. Data stored by these systems shall be made readily available in legible form. The electronically stored data shall be protected against loss or damage of data (e.g. by duplication or back-up and transfer onto another storage system).