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Emerging biopharmas should update eCTD compliance standards in 2008.

By Warren Perry

Feb. 1, 2008 | The New Year is a good time for emerging biopharma companies to look at what their larger counterparts are doing in terms of regulatory compliance, particularly with regard to global electronic submissions.

For various reasons, many emerging drug discovery companies believe they do not have to adhere to the same standards as large pharma companies. Perhaps they are unaware of what is required, or simply unfamiliar with the Food and Drug Administration (FDA). But these companies can only fly under the radar for only so long. Lack of preparation can cost them lots of time, resources, and money. Some understand this, but others delay putting systems in place for as long as possible.

Companies can’t do this half way — this is an electronic content world and paper submissions are quickly falling by the wayside. Effective January 2008, the FDA’s Center for Drug Evaluation and Research (CDER) mandated that all investigational (and/or marketing) applications be submitted in an electronic Common Technical Document (eCTD) format. In that light, there are three major areas that emerging life sciences companies should keep top of mind with electronic submissions to meet the new guidelines:

1. Audit Trails
This is the single most important aspect to have in place with a system in order to validate data and ensure they are 21 CFR Part 11 compliant. A submission system should be able to easily tell a company and the FDA who did what and when in system. An audit trail is focused on metadata and content within a system — it is not only about documents that are in the system. In general, despite best intentions, it is nearly impossible to anticipate future regulatory requirements and corresponding inquiries. Companies need to focus on things that are auditable now but must also be mindful of the future. A content management system that can easily absorb and adapt to future requirements is a huge plus.

2. Control of Content
The implementation, validation, training, and operation of a System of Record is as important as the content itself. The system must be installed and maintained to meet CFR21 Part 11 standards. Standard operating procedures (SOPs) must be set up to control operation of the system itself in order to be in FDA compliance. These can cover basic things such as rebooting the system, backup, and who has access to what data. These need to be under the control of the IT department to ensure proper operation of the system. A content management system that will be used to generate eCTD’s is mission-critical for emerging life sciences companies, and is typically their first such system. Thus compliance and regulatory affairs professionals don’t have access to much of the limited IT resources. Plus, IT is often not familiar with these types of systems. Companies may need to lean on vendors that can provide services and guidance around disaster recovery, virtual system access, and security measures.

3. Consistency Across Documents
The FDA can refuse to accept a company’s submission, even if it is electronic, for seemingly trivial things such as incorrect fonts or improper margins. Authoring templates are another important change for an emerging biopharma company when it comes to FDA submissions. While it does not necessarily sound rational (What does when it comes to the Federal government?), the FDA is a government agency comprised of rules and regulations. The FDA’s nitpicky document requirements go back to when all submissions were submitted in a paper format. Some of the text might not be legible if too close to the binding. Also, companies would often use smaller fonts to cram more information onto less pages and thus reduce costs. Companies need to have templates around content consistency in regards to medical writing, SOPs, and manufacturing. Each needs to clearly define the style and layout of different documents, and provide guidance as to the expected content. All documents need to follow the same format, typically through using templates. The best way to enforce consistent, current templates is through an electronic data management system (EDMS.)

For emerging biopharma companies focusing on these three areas of compliance, the first priority is to conduct an audit of what types of documents and data will need to be entered into an EDMS. Keep in mind the document types, sources, and who will need to review and potentially approve them. You must then determine what type of system best suits your needs, for example by attending a workshop with the Drug Information Association ( or the Regulatory Affairs Professional Society ( Both organizations can point to technologies that will help you morph from an emerging pharmaceutical company to the next Wall Street success story. 

Warren Perry is a compliance advisor with QUMAS. Email:


This article appeared in Bio-IT World Magazine. 
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