Can I maintain batch records viz. BMR / BPR electronically?
QUADSTM provides facility to maintain BMR, BPR, Equipment Calibration etc documents in a writable Adobe Acrobat PDF format. The documents are created, maintained, retrieved and have controlled access as per 21 CFR Part 11 (Sub-part B-11.10-(b) & (c)). Information generated online at shop-floor can directly be entered into the system to avoid manual paper work.