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Dear #SiteVisitor.FirstName#, Welcome to Forward Focus, the monthly newsletter of Tim Rosa Associates. Each issue will feature a viewpoint on a critical industry topic. We’ll focus on what's happening and what's coming down the line. The topics come from our customers—issues that you’ve told us about and keep you up at night. We work with clients in the technology, healthcare, and financial services industries, and hope the newsletter will be informative to all. Enjoy! R e g u l a t o r y C o m p l i a n c e : Documentation Holds the Key Blaise Pascal once said, "I have made this letter longer than usual, because I lack the time to make it short." Fortunately, Pascal lived in the seventeenth century and not in 2004. Today, U.S. companies are required to certify that their internal controls—processes and procedures, along with associated documentation and training—comply with stringent federal regulations from the FDA (Food and Drug Administration) and SEC (Securities and Exchange Commission). In a recent global survey conducted by PWC (PriceWaterhouseCoopers) of 160 senior financial services executives, 53% reported that reputational risk is the biggest risk their organization faces and 60% believe creating effective internal controls mitigates reputational risk. For many companies, documenting processes and procedures can be expensive, time-consuming, and distract them from their core businesses. Are you developing or enhancing internal controls? Are you developing the regulatory documentation on your own, outsourcing, or both? Can you meet the regulatory requirements? What about the filing deadlines? If not, how do you get started, avoid common pitfalls, and penalties? First, a little history... Do you need assistance with your validation documentation? Contact Tim Rosa Associates. 2 1 C F R P a r t 1 1 : A Brief History The pharmaceutical and medical device industries are increasingly automating all stages of discovery, development, and manufacturing for new drugs and medical products. In 1991, the industry requested that the FDA accept electronic records and electronic signatures for NDAs (New Drug Applications). The FDA responded by issuing the rule known as 21 CFR Part 11 (Electronic Records/Electronic Signatures) in March 1997. Part 11 describes the technical and procedural requirements that must be met if a company chooses to maintain records electronically and use electronic signatures. What is the regulation's highest-level purpose? To ensure that electronic records and signatures are trustworthy, reliable, and compatible with the FDA's public health responsibilities. And the costs of new drug development are skyrocketing. Based on a report released Bain & Co., it costs $1.7 billion to develop a new drug and just one compound now reaches the market for every 13 discovered and put in clinical trials.3 #letter.signature.repname##letter.signature.sitename# #letter.signature.email# #letter.signature.voice# #letter.signature.url#
1 Bartlett's Familiar Quotations, 1999 ed. 2 Compliance: A gap at the heart of risk management, PriceWaterhouseCoopers Global Financial Services, July 2003, p. 6. 3 New Drug Costs Sky-High: $1.7B, Bio-IT World, January 2004, p.1. |
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