Hate 21 CFR Part 11? Consider the alternatives. (Pan Pharma and a cautionary tale from Australia)

Today, I came across a news story about Pan Pharmaceutical Co., a contract pharma manufacturer in Australia, that reminded me of why regulations on electronic records are so important.  Criminals may bypass the law entirely, but at least having regulations in place addresses the human tendency to fudge data, fill information in later, or simply forget about it. To summarize: drugs that Pan had manufactured were recalled over two years ago after "discrepancies" (too much active ingredient in formulations was one of the milder problems) were found in the way that Pan manufactured the motion sickness drug, Travacalm, under contract with Key Pharmaceuticals.  The recalls led to $200 million in financial losses. It is alleged that the head of Pan Pharma had ordered his IT director to destroy all computer-based manufacturing records before a site inspection, and to make it impossible for computer forensics experts to recover it. This week in court, the former company's former IT director is said to have testified that the owner told him to "make sure that the data are not retrievable by anyone ¦ just do whatever you can." The owner has been charged with ordering destruction of the data while aware that it might be required in court. This could lead to consumer lawsuits, suits by Key Pharmaceuticals, on behalf of which Pan made the medicine, and prosecution for breach of license.  Last month, Pan's owner had had the temerity to sue Australian regulatory authorities for loss of business, income, etc. That suit is unlikely to get far, given recent developments. But, if that isn't enough, another former director of the company has been implicated in exporting counterfeiting drugs. -AMS