Obsolete documents identifying

The standard requires that a master list or equivalent document contol procedure identifying the current revision status of documents be established and be readify available to preclude the use of invalid and/or obsolete documents. It is important to note that this requirement only applies to documents and not to data. 

One way of identifying obsolete documents is to write SUPERSEDED or OBSOLETE on the front cover, but doing this requires that the custodian is informed. When a version of a document is replaced with a new version, the withdrawal of the obsolete version can be accomplished in the amendment instructions that accompany the revision. When documents become obsolete by total replacement, their withdrawal can also be accomplished with the amendment instruction. However, where a document becomes obsolete and is not replaced there needs to be a Document Withdrawal Notice which informs the custodian of the action to be taken and the reason for withdrawal. 

What means are used to identify obsolete documents retained for legal and/or knowledge preservation purposes ... 

A master list or an equivalent document control procedure Identifying the current revision status and distribution of documents In the management system shall be established and shall be readily available to preclude the use of Invalid andfor obsolete documents. 

Are all obsolete or invalid documents removed from use, or suitably identified ... 

The control which you exercise over external documents is somewhat limited. You cannot for instance control the revision of such documents therefore all the requirements concerning document changes will not apply. You can, however, control the use and amendment of external documents. You can control use by specifying which versions of external documents are to be used and you can remove invalid or obsolete external documents from use or identify them in a way that users know that they are invalid or obsolete. You can control the amendment of external documents by controlled distribution of amendment instructions sent to you by the issuing agency. 

All current SOPs should be available in the work area in which they are used. Each person who may need specific SOPs for his/her work should also have them, perhaps in a file near his/her desk. In addition, there should be a location in which master SOPs for all activities are filed and all SOPs should also be archived so that past revisions are accessible. All obsolete SOPs, however, should be removed and filed away from the work area and clearly identified as obsolete. The decision to revise an SOP must be based on sound observations and protocols that point to improved data accuracy and integrity. Such decisions can be based on a new procedure, a new piece of equipment, etc. SOPs are dynamic documents and should be considered for revision on a regular basis with input from the technicians and scientists doing the work. 

All SOPs, including current and obsolete versions, must be retained. This enables future reconstruction of the procedures used to perform any study, independent of personnel who were Involved in the study. Documenting the specific SOPs used in the study records clearly identifies the appropriate SOPs. 

IV.31. Changes to documents should be identified and recorded, and should be subject to review and approval, in accordance with documented procedures, by the original document review and approval functionaries or other designated persons or organizations having access to the relevant information. Distribution of revised documents, and information concerning their status, should be prompt and timely. Care should be taken to ensure that out of date, redundant documents are destroyed or clearly marked as such to prevent further use. When necessary an original document file should be established to maintain the history and to assure traceability these documents should be marked as obsolete to prevent any further use. 

Procedures shall be established to ensure that controlled documents and drawings necessary to accomplish activities are available at the locations where the activity will be performed prior to commencing the work and that obsolete or superseded documents and drawings are removed and replaced by applicable revisions In work areas In a timely manner. A master list or equivalent document control system shall be established to identify the current revisions of controlled documents and drawings. 

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