I have an undergraduate degree in European History, French Revolution to the Present, which was then 1978. Perhaps not the most marketable of college degrees but for a lover of history it was a ton of fun. One of my favorite study subjects was the French Revolution, particularly the phase from 1789-1792; the period of almost Constitutional Monarchy, before the King was executed and the Terror set in. While this part of the Revolution failed, it does not mean that was not a noble effort by the French people, who had been inspired in large part by the success of our American Revolution.
In the spring of 1789, King Louis XVI, called the Estates-General into session. It was a national assembly that represented the three “estates” of the French people – the nobles, the clergy, and the commons. The Estates-General had not been assembled since 1614, and its deputies drew up long lists of grievances and called for sweeping political and social reforms.
The Third Estate, which had the most representatives, declared itself the National Assembly and took an oath to force a new constitution on the king. Initially seeming to yield, Louis legalized the National Assembly under the Third Estate but then surrounded Versailles with troops and dismissed Jacques Necker, a popular minister of state who had supported reforms. In response, Parisians mobilized and on July 14 stormed the Bastille, a state prison where they believed ammunition was stored, and the French Revolution began. On this date in 1789, one of the most dramatic events occurred; The Oath of the Tennis Court, where the deputies of the Third Estate, which represent commoners and the lower clergy, met on the Jeu de Paume, an indoor tennis court, in defiance of King Louis XVI’s order to disperse. In these modest surroundings, they took a historic oath not to disband until a new French constitution had been adopted.
The Oath of the Tennis Court was recorded for each member who took part. In other words, there was full documentation of who took the oath and the substance of the oath taken. It was a very good example of what I continue to hammer as the three most important things in Foreign Corrupt Practices Act (FCPA) compliance, that being Document, Document, and Document. However, many people ask what that means more than simply writing something down.
I am currently attending the UL EduNeering Leadership Forum and there are several compliance representatives from the pharmaceutical industry in attendance. One thing I have learned is that the pharmaceutical industry has a definition of Good Documentation Practice (GDP), which describes standards by which documentation is created and maintained in the industry. Although the US Food and Drug Administration (FDA) sets some GDP standards, others fall under the Current Good Manufacturing Practice (cGMP). Finally, all pharmaceutical, bioscience and healthcare companies, as well as their vendor partners, must observe GDP or face warnings or penalties levied by the FDA.
In an article by Barry Peters and Heather D. Ferrence, entitled “Importance of Implementing Good Documentation Practices”, they note that the World Health Organization (WHO) says the some of the purposes of GDP include:
- To define the specifications and procedures for all materials and methods of manufacture and control.
- To ensure that all personnel concerned with manufacturing know what to do and when to do it.
- To ensure that authorized persons have all the information necessary to decide whether or not to release a batch of a drug for sale.
- To ensure the existence of documented evidence, traceability and to provide records and an audit trail that will permit investigation.
- To ensure the availability of the data needed for validation, review and statistical analysis.
Moreover, “an essential part of all aspects related to Good Manufacturing Practices (GMP), adhering to GDP helps prevent errors within various processes, such as product quality and safety, state of manufacturing facilities and other related activities, and ensures that each company is following strict standard operating procedures (SOPs). In a regulated industry, such as pharmaceuticals, quality cannot be assured without accurate documents and GDP.” Finally, it is to be noted that “it is imperative that all documentation is concise, legible, accurate and traceable.”
Adapting the authors’ suggestions specific to the pharmaceutical industry, I submit the following for your consideration in your Document, Document, and Document practices in FCPA compliance:
- Lack of proper record keeping when documents are transferred from one department to another.
- Critical oversight regarding document issue, data collection and document review.
- Consistent labeling that includes identification codes and any document revision codes.
- Ensuring proper security and storage of documents during review process.
- Proper and consistent identification of all documents through all processes.
- Ensuring that all those whose signatures appear on the documents understand why they signed the documents as well as any and all responsibilities associated with the signing of the documents.
To the above list I would add some additional suggestions:
Document maintenance
- Regularly reviewed and kept current
- Retained and available for appropriate duration
- Electronic document management systems are validated
- Electronic records are backed up
Document modification
- Handwritten modifications are signed and dated
- Altered text is not obscured (e.g., no correction fluid)
- Where appropriate, the reason for alteration must be noted
- Controls exist to prevent the inadvertent use of superseded documents
- Electronic versions can only be modified by authorized personnel
- Access to electronic versions must be controlled by password or other means
- A history (audit trail) must be maintained of changes and deletions to electronic versions
- Supporting documents can be added to the original document as an attachment for clarification or recording data. Attachments should be referenced at least once within the original document. Ideally, each page of the attachment is clearly identified (i.e. labeled as “Attachment X”, “Page X of X”, signed and dated by person who attached it, etc.)
Setting and following good document practices is an essential aspect of compliance with federal regulations, such as the FDA, who governs large aspects of the pharmaceutical industry, and other federal laws such as the FCPA. So in addition to documenting your actions, you should also follow a written protocol for document maintenance and subsequent modifications.
This publication contains general information only and is based on the experiences and research of the author. The author is not, by means of this publication, rendering business, legal advice, or other professional advice or services. This publication is not a substitute for such legal advice or services, nor should it be used as a basis for any decision or action that may affect your business. Before making any decision or taking any action that may affect your business, you should consult a qualified legal advisor. The author, his affiliates, and related entities shall not be responsible for any loss sustained by any person or entity that relies on this publication. The Author gives his permission to link, post, distribute, or reference this article for any lawful purpose, provided attribution is made to the author. The author can be reached at tfox@tfoxlaw.com.
© Thomas R. Fox, 2014
FCPA Compliance and Ethics Blog 