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By Curt Finch
Implementing timesheet software that contains all of these features is necessary in order for your business to be able to comply with Part 11 regulations. According to www.21CFRPart11.com, the right vendor “can offer an application containing the required technical requirements of a compliant system.” [see www.21cfrpart11.com/pages/faq/index.htm]. This will enable you to make the transition from paper to electronic records as painless as possible.
In 2007, the FDA plans to release its amendments to 21 CFR Part 11, and this will change the way laboratories manage their electronic records. The goal is to create and thoroughly document a pragmatic process by which regulatory compliance initiatives can be prioritized while still maintaining overall productivity. The deliverable is a careful, thorough, risk-based methodology that enables companies to build quality into their processes based on qualified regulatory risks and identification of key areas for increasing efficiency.
Unfortunately, even after ten years, there is still much confusion over 21 CFR Part 11. Some of this confusion is caused by software vendors who are trying to sell in this sphere. For example, it is not possible for any vendor to offer a turnkey 'Part 11 compliant system,' and any vendor who makes such a claim is wrong. Part 11 requires both procedural controls (i.e. notification, training, standard operating procedures and administration) and administrative controls to be put in place by the user in addition to the technical controls that vendors offer. At best, you can find an application that contains the technical requirements of a compliant system.
Another area of confusion concerning Part 11 is handwritten signatures. Having handwritten signatures on paper is only acceptable if the signatures are somehow linked to electronic records so that signers cannot repudiate records. What this means is that electronic and handwritten signatures executed electronically must be verifiably bound to their respective records to ensure that signatures could not be excised, copied, or otherwise transferred to falsify another electronic record. Not surprisingly, technology solutions typically do this better than paper-based ones.
If you are a small business who works with pharmaceutical companies, then you must be in compliance with all provisions of 21 CFR Part 11, according to the FDA. More information is available at http://www.21cfrpart11.com.
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