Complying with Part 11 can be a difficult thing to do. This is in part due to the fact that FDA recalled all the guidances concerning the implement of Part 11 in September 2003. Companies have been left to their own means to interpret Part 11, since the FDA leaves the inspector’s interpretation to "his own discretion."
Originally, the regulation was drafted and issued by the Agency at the request of the regulated industries. These industries requested the FDA to give guidance on the use of electronic records and signatures for submissions to FDA. Part 11 was issued on August 27, 1997 and it was quickly realized that the law would be difficult to implement (from the side of the industry) and control (from the side of the FDA).
Following a restructuring of the FDA in September 2003 the cumbersome guidances were recalled. Having someone on your team who is knowledgeable about the 21 CFR Part 11 compliance process and any updates made to the regulations is imperative.
What Is Part 11 of the Code of Federal Regulations?
The FDA’s CFR 21 Part 11 covers the rules for electronic records and signatures and other record-keeping procedures. This legislation covers all aspects of the use of electronic records (Subpart B) and electronic signatures (Subpart C) in the regulated industries.
Manufactures must abide by this law in order to comply with FDA’s regulations. As usual, it is necessary to provide documented evidence of all activities executed in order to comply with this regulation.
Training Requirements for Employees for Part 11 Compliance
When a company implements a policy of using electronic records and signatures as original documents, this must be clearly stated in the validation plan of the affected system.
In order to keep all employees of the company "in the loop" it is necessary that the computerized system, which is Part 11 relevant, be trained rigorously. This ensures everyone who uses the system is aware of the consequences of the Part 11 relevant system. The training program must be documented and archived with the other validation documentation generated for the system.
The FDA makes it clear that you must be able to keep and audit all records as well as verify the person or persons who make claims or share data with others. Failing to comply with these rules could lead to serious consequences for your company. Therefore, it is critical to have someone who understands the legal rules that must be followed by medical, dental and pharmaceutical product manufacturers.
GxP-CC is a leading global compliance consultancy company for those in the medical device, pharmaceutical and dental lab industries. Contact them for help with Part 11 compliance or any other compliance issues you are experiencing.