Regulated Content

MANAGING REGULATED PRODUCT CONTENT WITHIN LIFESCIENCES AND MEDICAL DEVICE INDUSTRIES

The product information that must accompany a pharmaceutical product or medical device is regulated, scientifically validated information that is relied upon by the healthcare professionals who prescribe it, and by patients and consumers who need to be informed on its safe use. As a result, this product information must be accurate and up to date to ensure patient safety and wellbeing.

The regulatory requirements for the type and format of product information can vary between different countries, and will likely also vary based on product pack type or dosage form.

For globally marketed pharmaceuticals and medical devices, this represents a significant operational challenge, where failure to adequately control the many, different combinations and variations of product information will result in regulatory non-compliance and potential product recall.

To compound this challenge, there is a growing demand to deliver product information through digital formats and channels, including social media, in addition to traditional physical formats such as leaflets, inserts and data sheets. The ability to manage electronic product information is critical in enabling digital healthcare initiatives and better-informed patients.

As a result, one of the growing operational problems for clinical trial organizations, pharmaceutical and medical device manufacturers is in assuring the provision of the correct, approved product information, consistently and compliantly, across all physical and digital channels.

How PRISYM ID Technology Can Help

At PRISYM ID, our innovative technologies can be used to control this product information as content ‘components’, such as indications, warnings, precautions, symbols, dosage and expiration, whether used in physical labels, inserts and packaging, or as electronic product information in e-labels, e-IFUs (electronic Instructions For Use) or online communications.

Being able to identify, control and report on where these content components are required or used, across physical and digital formats and channels, represents a critically important business capability. Significantly, this content component-level capability is one that the document management systems in use widely today are simply unable to provide.

If you recognize this challenge within your pharmaceutical or medical device organization, and would like to understand how PRISYM ID’s unique technologies can provide you control over the content components in your product information, across physical and digital channels, please get in touch.

 

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