Regulatory/GMP Compliance

Feb 15, 2004
BioPharm International
How can you be sure only authorized users are entering data into your system? Is your electronic signature yours alone? Are you sure operators can?t invalidate your data? Is your company in compliance with FDA data security regulations? The second article in our series on 21 CFR Part 11 will help you answer these questions.
Feb 15, 2004
BioPharm International
Protecting the integrity of data is a challenge of 21 CFR Part 11 compliance. Integrity requires records to be complete, intact, and maintained in their original context ? associated with the procedures which were used to create the data.
Feb 15, 2004
BioPharm International
The FDA?s risk-based approach to pharmaceutical cGMPs applies to 21 CFR Part 11 enforcement as well. Understanding different methodologies for assessing and managing risk will help you develop and begin to implement a compliance plan.
Feb 15, 2004
BioPharm International
The FDA rule on electronic signatures and electronic records was issued in 1997, but the details of implementation are still being debated. The 2003 FDA guidance redefines the scope of 21 CFR Part 11. Understanding which records now fall under the scope of the rule can help you begin implementing your compliance plan.
Feb 15, 2004
BioPharm International
Networks are part of the compliance picture. Recent FDA warning letters show the agency considers network monitoring and qualification a necessary part of maintaining the security and integrity of electronic records.
Feb 01, 2004
BioPharm International
This article focuses on the front end of qualifying a new raw material from a given supplier. Once qualified, this status must be maintained by periodic review and requalification.
Jan 01, 2004
BioPharm International
Training programs do not have to be complex to be successful. There are basic elements, however, that all must have to meet FDA requirements and ensure that employees have the knowledge and skills to maintain high quality standards.
Oct 01, 2003
BioPharm International
Biotech companies are among the most intensive instrumentation users of any FDA-regulated business. Because of the complex nature of these companies' research and manufacturing, they typically have a larger number of instruments per employee.
Aug 01, 2003
BioPharm International
Good laboratory practice is the central dogma of all laboratory research and investigation - it's your commitment to regulators - and poor laboratory controls are a common cause of 483 observations and preapproval inspection failures.
Jul 01, 2003
BioPharm International
A successful outcome to an FDA inspection is the fruit of planning, preparing, and training. Cultivate confident employees who are appropriately coached and clear about their responsibilities.
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