Skip to main content
SpringerLink
Log in

A compliance office for heavily regulated enterprises — a best practice approach to meeting US FDA requirements

  • Published:
BT Technology Journal

Abstract

In order to thrive in today’s world of connectivity, convergence of services, and globalisation, heavily regulated companies must partner with their service providers to ensure both high quality service and regulatory compliance. Service providers must support clients from an environment that satisfies the regulatory needs, including that the service providers’ software tools are validated to the standards required by the US Food and Drug Administration. This paper describes the unique approach BT has taken to meeting these requirements, in particular for our pharmaceutical clients.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Swann J P: ’History of the FDA’, PhD, FDA History Office — http://www.fda.gov/oc/historyoffda/fulltext.html

  2. 21 CFR 210: ‘Current Good Manufacturing Practices for Drugs — General’ and 21 CFR 211: ‘Current Good Manufacturing Practices for Finished Pharmaceuticals’, Code of Federal Regulations, US Food and Drug Administartion (2005).

  3. ’Computerised Drug Processing: Input/Output Checking’ (FDA 1982 a) and ‘Computerised Drug Processing: Identification of ‘Persons’ on Batch Production and Control Records’, (FDA 1982 b) — http://www.fda.gov/

  4. ’Understanding, Experience, and Technology for Compliance’, Systems Validation for 21 CFR Part 11 Compliance, MetricStream Inc (2006) — http://www.metricstream.com/insights/sys_validaiton.htm

  5. Huber L: ’Validation of Computerised Analytical and Networked Systems’, CRC Press LLC (2002).

  6. Good Automated Manufacturing Practices (GAMP) Forum — http://www.gampforum.com/

  7. EU Directive ’EC Guide to Good Manufacturing Practice for Medicinal Products’, (Commission of the EC 1992); Australian ‘Code of Good Manufacturing Practice for Therapeutic Goods’ (TGA 1990); UKL Medicines Control Agency (MCA); GAMP4 (GAMP Forum 2001) with 14 chapters, 25 Appendices.

  8. SMB Validation — www.smbvalidation.com/q21cfr.html

Download references

Authors
  1. J. K. Himmelreich
    View author publications

    You can also search for this author in PubMed Google Scholar

About this article

Cite this article

Himmelreich, J.K. A compliance office for heavily regulated enterprises — a best practice approach to meeting US FDA requirements. BT Technol J 25, 41–49 (2007). https://doi.org/10.1007/s10550-007-0007-7

Download citation

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10550-007-0007-7

Keywords

Search

Navigation