spacer
home > epc > summer 2002 > why, when and how to implement electronic data capture - core decision points
PUBLICATIONS
European Pharmaceutical Contractor

Why, When and How to Implement Electronic Data Capture - Core Decision Points

European pharmaceutical companies wishing to supply the US market are regulated by the US Food and Drug Administration (FDA). There has been a 10-year dialogue between the FDA and global drug manufacturers about the acceptance of and mechanisms for implementing validated electronic signatures to replace manual sign-off throughout the drug development and manufacturing process. This article reflects on the practical impact on European pharmaceutical companies of the regulation finally agreed between the FDA and the industry, affectionately known to all as 21 CFR Part 11.

Modern LIMS to Help Support 21 CFR Part 11

In the early 1990s, members of the pharmaceutical industry met with the US Department of Health and Human Services and the Food and Drug Association (FDA) to determine how a paperless record system could be accommodated under the current Good Manufacturing Practice (GMP) regulations. In March 1997, after a six-year iterative development process with the industry, the FDA issued the final rule. Following a five-month grace period, the rule became effective on 20th August 1997.

The rule sets forth the criteria under which the FDA considers electronic records and electronic signatures to be equivalent to paper records and handwritten signatures. The rule is an extension to the predicate rules for GXPs - GLP: 21 CFR 58 for laboratories; GMP: 21 CFR 211 for manufacturing; 21 CFR 820 for medical devices; and GCP: 21 CFR 320 for clinical environments. 21 CFR Part 11, the FDA's final rule on using electronic records and electronic signatures, affects all pharmaceutical companies in Europe that sell products in the US. Even for those who do not sell within the US now, this regulation is still very important because in the near future all regulatory authorities will be working according to a similar standard.


Read full article from PDF >>

Rate this article You must be a member of the site to make a vote.  
Average rating:
0
     

There are no comments in regards to this article.

spacer
By Peter Boogaard, European Applications Manager at Applied Biosystems

Peter Boogaard has been involved in the field of laboratory automation since the introduction of commercial LIMS systems in 1981. Additionally, his career path has included several positions within database companies, including Oracle and Informix Corp. He has been Product Manager for the Informatics LIMS business unit in the US.

Peter has held several positions within the European Informatics organisation, including marketing, new business development and manager professional services. Peter Boogaard's current responsibility is managing the European Applied Biosystems Marketing Intelligence group in the Netherlands.

Print this page
Send to a friend
Privacy statement
News and Press Releases

Drive for generics sees Korea increasingly attractive to international pharma

Amsterdam, 31st July 2019: Already home to more than 40 pharmaceutical multinationals, Korea is on course to become a global biotech and pharmaceutical hub by 2025, driven by the surge of international partnerships, biosimilars, an expansion in the export of finished formulations and a robust generics market.
More info >>

White Papers

Planning the Execution of a Viral Clearance Study

Eurofins BioPharma Product Testing

Viral clearance studies are a necessary component of any regulatory submission for clinical trials or commercial product approval for all biopharmaceutical products. These studies are performed to evaluate the capability of the purification process to remove or inactivate viruses that could potentially contaminate the starting material. They are complex studies that require substantial financial and personnel resources, as well as specialized scientific expertise to perform. As such, viral clearance studies are often performed at a qualified contract testing laboratory rather than in-house. When multiple parties are involved in this process, clear communication and a comprehensive understanding of the approach and timeline is critical.
More info >>

 
Industry Events

The Universe of Pre-filled Syringes and Injection Devices

22-23 October 2019, The Swedish Exhibition & Congress Centre Gothia Towers Hotel

PDA’s Universe of Pre-filled Syringes and Injection Devices has become the must-attend meeting for everyone working in the field, and is now the world’s largest conference on this subject
More info >>

 

 

©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement