Regardless whether it's ISO 9001, EU GMP, 21 CFR Part 11 or another standard - the scope of mandatory and self-governing regulations concerning the handling of documents has grown steadily over recent years. Nevertheless, the documentation of critical core processes still plays a secondary role in many companies. Lapses in this area can result in significant sanctions. In the pharmaceutical industry these range from restrictions on production or marketing permits to the closure of entire production facilities. The economic damage caused often ranges in the multi-million dollar region. eSOPS from fme provides you with an efficient solution for the electronic management of critical core processes. It allows you to safely fulfi ll the legal requirements for the processing, checking and approval processes of documents. eSOPS also simultaneously reduces the duration of these processes in your company by a significant margin.

BENEFIT

• Reduction of costs for SOP administration by more than 50%
• Shortening of process turnaround times by up to 90%
• Fulfillment of legal requirements regarding the compliance of documentation processes thanks to complete control over the review and approval process
• Short implementation time and calculable budget thanks to out-of-the-box, confi gurable software components and validation documentation