Government Regulations

21 CFR Part 11

21 CFR Part sets forth the FDA standard for electronic signatures and tracking of all changes to your database.  Organizations that wish to have electronic record sand electronic signatures accepted as equivalent to the corresponding paper records must comply with this standard.
 

ISO 9001, 16949, 13495

ISO 9001 quality management standards and guidelines are used as the basis for establishing quality management systems.
 

TITLE III (US) of the Higher Education Act of 1965 (HEA) was enacted to provide Federal assistance for a program to strengthen the administrative capacity, and establish an endowment fund in order to achieve growth and self-efficiency for developing institutions.  Amendments to the Act have altered some of the elements of the program, but it basically remains as written -- an instrument to provide assistance to institutions demonstrating a constructive effort to strengthen themselves.  The annual amount collected by Congress to support Title III Programs exceeds 200 million dollars.  In recent years,  nearly 500 colleges and universities throughout the United States have received the Title III funds annually.

 

Public Sector Accountability Act, 2001 (Bill 46) The Ontario government has recently introduced sweeping reforms to ensure that all public sector institutions are accountable for the public funding they receive -- this includes every agency of the Crown in Ontario and applies to all post-secondary institutions, hospitals, municipalities, school boards, and provincial ministries receiving government funding.
Bill 46 stresses accountability and transparency, to improve program efficiency and effectiveness. Organizations must publish an annual report, and prepare a business plan that includes a balanced budget. They will also be subject to public audit and inspection on a yearly basis.