Regulated Environments
The cost of 21CFR11 compliance has caused many companies to continue with paper notebooks as the primary record in at least some of their regulated processes. Whilst this approach avoids costly and rigid electronic record keeping systems, it does mean users still need to deal with the problems of the traditional Bound Laboratory Notebook.
Amphora’s CompliantPad™ security paper provides all the security and control associated with a Bound Laboratory Notebook, with all the convenience associated with loose leaf paper. CompliantPad™ can be delivered as:
- Separate “unbound” laboratory notebooks, which can be used and managed just like the Bound Laboratory Notebook, but can be easily used with computer printers. In addition, where signatures are required, the pages that need signing can be sent through the signature process, without the scientist losing access to the full notebook.
- As loose leaf security paper, which can be used for batch records, compliance forms etc.
The CompliantPad™ solution is used by thousands of scientists around the world, as a simple, pragmatic way of keeping records in an regulated environment.