From the earliest phases of research and development to manufacturing and distributing new products, pharmaceutical and biotechnology companies are challenged by the sheer volume and complexity of the information they need to manage. They’re also heavily regulated.
Recognizing the importance of documentation to operational efficiency and compliance, industry leaders are improving its quality and consistency in these 4 key areas.
In the interests of improving product safety and reducing risk, companies are reviewing their SOPs and work instructions for accessibility, accuracy and clarity. Eliminating gaps, inconsistencies and obsolete content can greatly reduce errors.
Submission processes for new drugs and devices are documentation-intensive. Unclear or inaccurate documents are often the cause of long delays in approval of new products. Companies gain competitive advantage by submitting clear, accurate and unambiguous documentation that minimizes regulators’ requests for clarification or other concerns.
Outsourcing of clinical research, manufacturing and other core functions can boost efficiency but also increase exposure to risk and regulatory intervention. Pharmaceutical and medical device companies have learned that outsourcing is an area where the quality and consistency of documentation is critical to success, especially where translation or localization issues are concerned.
Your documents contain valuable information that maximizes efficiency and safety, promotes best practices, and ensures high-quality customer experiences. However, the best documents in the world don’t mean a thing if they languish in binders or get lost in portals, never seeing the light of day.
With a digital solution, your documents are always up-to-date and accessible to your employees. Dynamic and interactive content like videos, images, flashcards and quizzes make the experience memorable and impactful.
Information Mapping has been helping pharma and biotech companies improve and digitize their procedure and process documentation for many years. In our white paper '7 Features of Successful Compliance Documentation' we'll give you 7 essential features to keep in mind when writing Quality Manuals, SOPs, Work Instructions, and so one.
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