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 3 key areas.
1. Reducing human error and its sometimes grievous consequences
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.
2. Streamlining submission processes
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.
3. Taking the risk out of outsourcing
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.
Join us on April 30 at 2PM ET for our new webinar, SOPs: the neglected heart of GMP. Allison Dean, Information Mapping’s Director of Professional Services, will share valuable insights on how to ensure that your documentation is helping your company operate efficiently and compliantly.