Osellus offers a full suite of software development and consulting services focussed specifically on U.S. Food and Drug Administration ("FDA") 21 Code of Federal Regulations Part 11 ("21 CFR Part 11" or "Part 11") regulation on electronic records and signatures.

21 CFR Part 11 compliance is an important consideration for an increasing number of clinical research and pharmaceutical projects. Organizations that rely on Osellus Part 11 services are able to reach and maintain compliance across their information systems in minimum time and reduced cost. Osellus Part 11 services help to prepare your applications for the eventual FDA audit, irrespective of whether you develop software in-house or use Osellus to develop your software application.

Osellus 21 CFR Part 11 solution includes the following services and deliverables:

• Ground up development of new software applications that are warranted to be compliant with the Part 11 regulation
• Assessment of existing software applications and information systems in order to determine compliance level
• Gap analysis, risk assessment and development of compliance roadmap
• Mock audit orchestration and accompaniment of client through actual FDA audits

To receive a no-charge obligation free consultation on how Osellus Part 11 services can help your information systems can achieve FDA compliance contact us at This e-mail address is being protected from spam bots, you need JavaScript enabled to view it or at +1-416-603-6667.