Life sciences regulatory compliance doesn’t end at the walls of the research lab, the clinic, or the pharmacy. Every aspect of life science operations, from sales and marketing to education, training, and lab operations, is subject to regulations, and new or revised regulations are being issued on a near-daily basis. With pages and pages of documentation to read through, business leaders and compliance officers simply don’t have the time to onboard all the new information, much less enforce the rules.
Lately, however, AI technology has been assisting life sciences businesses to assimilate new and revised regulations without having to spend valuable time reading volumes of regulatory documentation. New AI apps extract critical information from the documentation and deliver it in a kind of “readers digest” form. Compliance officers can then apply these actionable insights to their operations.
But that still leaves a pile of internally-generated documents for a compliance officer to comb through, searching for non-compliant language. Sales and marketing literature, training manuals, and educational materials are all vulnerable to compliance issues. Parsing the content in these printed materials is just as time-consuming and error-prone as reading the regulatory documents.
Digital technology comes to the rescue here, too, in the form of document conversion. Digitizing the printed materials creates a searchable database. When a new regulation is issued, the AI app outputs a condensed pertinent version. Then the keywords of the condensed regulation can be matched against the keywords of the digital document database. Outdated or conflicting documents can be flagged automatically, and new compliant documents can be generated quickly.
And in the event of an audit, speedy retrieval of documents shortens the audit and gives auditors confidence in the overall management of records. Digitized documents are delivered with electronic speed, far faster than staffers can locate paper documents in filing cabinets or archived storage.
The average cost for non-compliance is over $14 million. No life sciences business, large or small, wants to pay such enormous costs. Incorporate AI and document digitization into your compliance protocol, and keep that money where it belongs: in your profits.
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