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Hello everyone,
I am working on improving the issuance of controlled documents (forms for QC testing). I found this guidance for industry called
"Data integrity and Compliance with Drug cGMP Questions and Answers" and question 6 addresses issuing blank forms. Bound paginated books is an option I have been leaning towards because is specially convenient for use in the lab, control and reconciliation but if some forms are needed to be filed with the master batch record is not an ideal option. I am tangled there because many of the forms can't be issued by batch either. Do you have any recommendations? My alternative to bound books is a cover sheet where the forms issued will be recorded ( our system is set up to provide unique copy numbers), how many who received and in what lots if some of those were for final testing. Thank you for your input! I just want to be in alignment with current practices.