Documentation

Principle

400. The objectives of good documentation are to define the system of information and control, to minimise the risk of misinterpretation and error inherent in oral or casually written communication, and to provide unambiguous procedures to be followed.
     • Records should document the outcome of the activities carried out, and parameters measured. The system should provide a means of collating information, confirmation of performance and traceability.

General

401. All processes and associated activities in the manufacture of product should be documented and the documentation controlled.
402. Documentation should be legible, accurate, readily identifiable and retrievable.
403. Documentation should not include superfluous data and should be written in the imperative (i.e. as instructions rather than statements of what is desired or should happen).
404. Documents should not be handwritten; although, where documents require the entry of data, these entries should be made in clear, legible, indelible handwriting. Sufficient space should be provided for such entries.
405. Documents should be approved, signed and dated by appropriate and authorised persons.
406. Documents should have unambiguous contents; title, nature and purpose should be clearly stated. They should be laid out in an orderly fashion and be easy to check. Reproduced documents should be clear and legible. The reproduction of working documents from master documents must not allow any error to be introduced through the reproduction process.
407. Any alteration made to the entry on a document should be signed and dated in permanent ink; the alteration should permit the reading of the original information. Where appropriate, the reason for the alteration should be recorded.
408. The manufacturer should establish, implement and maintain a procedure for controlling documents. The procedure should ensure that:
     • documents are authorised;
     • documents are reviewed at regular intervals to ensure that they are current;
     • multiple copies are controlled with a distribution list;
     • obsolete documents are removed from all points of issue and use, and controlled to prevent further use;
     • the version of a document should be uniquely identified.
409. The retention period and storage conditions for all documents should be defined and comply with legislation.
410. A system should be in place to ensure that records containing confidential information are secured from unauthorised access.
411. Data may be recorded by electronic data processing systems, photographic or other reliable means, but detailed procedures relating to the system in use should be available and the accuracy of the records should be checked.
412. If documentation is handled by electronic data processing methods, only authorised persons should be able to enter or modify data in the computer and there should be a record of changes and deletions; access should be restricted by passwords or other means and the result of entry of critical data should be independently checked.
413. Records electronically stored should be protected by back up. It is particularly important that the data are readily available throughout the period of retention.
414. Records should be maintained to demonstrate that the quality system has operated effectively and that the specified requirements have been met.
415. Records should be completed at the time each action is taken and in such a way that all significant activities concerning the manufacture and disposition of products are traceable.

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