Life sciences companies are document and information intensive businesses that operate under continual scrutiny from both domestic and international regulatory authorities. Mounting business pressures in the pharmaceutical, biotechnology, medical device, health care, clinical services, and related industries require that these companies wring ever greater returns from their operations. In this unforgiving environment it is vital that organizations maintain compliance with governmental regulations such as FDA's 21 CFR Part 11, the US Health Insurance Portability and Accountability Act (HIPAA), and industry standards as efficiently and effectively as possible.

Sitrof has many years of experience implementing content management and business process automation solutions for clients in the life sciences. Our staff are experts in computer system validation and in the specific requirements faced by regulated industries. Read our case studies to see some of our Document Management and Records Management success stories for companies like yours.

Sitrof Compliance Module built for Xerox DocuShare The Sitrof Compliance Module built for Xerox DocuShare provides an affordable, easy to use, fully compliant electronic document management solution. The Sitrof Compliance Module enables your organization to electronically manage SOP's, Work Instructions, Master Production Records, Training Records, Annual Product Reports, and other controlled content. Key benefits of the Compliance Module include: afforable - you will be up and running in days not months fully compliant with 21 CFR Part 11 electronic signatures eliminate the need to circulate and retain paper documents easy to use and administer includes full life-cycle validation documentation (from Validation Master Plan through Final Validation Report) Learn more >