We are implementing an Electronic Documentation System in my plant (IDEA forCon), that aplies part 11, and we have designed a flow chart with the standar tools of the system to create, modify, mantain and sign the SOPs of the plant. All the existing SOPs (in paper format) will be scanned and charged in the system through an accurate process that belogs to the validation cycle.
The established statement by the corporation (based on famous Guideline 2003) is that these documents cannot be considered as electronic records and only a new version edited from that existing created into the system, it can be, and, the use for this documents cannot be for official purposes (controled copies) but information use.
In my opinion that approach, limit, unhelpfully, the use of the system and does not confer additional security to electronic records.
Could you give me some feedback please?