Reference Documents:

Need to quickly reference a regulation, standard or guidance? Instead of fumbling through your personal archive or searching the net, try this area of the library for easy reference and download or a link to a site where the document can be purchased. Unfortunately not everything can be free; there are copyright laws!! We have also provided some great interpretation and application documents that may be of use in developing a compliant and efficient quality system to support your business!

Quality System Maps:

These terrific graphical representations of typical quality systems supporting Pharmaceuticals and Medical Device businesses are invaluable for assessing how complete your system is. These can also be used to map out your quality manual or QMS documentation. Check them out!

Procedure Templates:

Ever need a place to start when writing a new or improved standard operating procedure (SOP)? We all have been in that place! Here are some free templates for you to use in getting your procedure out there. We also have hundreds of templates in our archives. Just drop us a line on the Contact Page and we will get it to you ASAP.

If you do not find what you need on the site or in the referenced links. Please contact us and we will try to provide it to you or give you a place to go to get it. Our mission is to help you out. Also, register for the discussion forum and post a request for help. A colleague may have exactly what you need!

Organization Links

Home Page for the Food and Drug Administration (FDA)



Trade association representing medical device manufacturers, makers of medical equipment, software and supplies.

American Society for Quality (ASQ) is the world's leading membership organization devoted to quality.



Official site of the society for technical professionals in the healthcare manufacturing industry.




PDA provides scientific, technical and regulatory information on pharmaceutical and biopharmaceutical manufacturing and quality worldwide



The Regulatory Affairs Professionals Society (RAPS) is the leading worldwide member organization devoted to the health product regulatory profession.

Professional networking site - Find past and present colleagues and quickly.

Get the latest enforcement information by visiting the
Warning Letter Page