DDi LLC articles
In order to scale, you must reuse content; To reuse content, you must standardize content; To create standardized content, you must develop standards that all content creators adhere to
Why Best Practices are needed for Writing for Reuse?
Because without reuse, you cannot deliver content at scale or achieve efficiency
And if you products sell globally, you also start with best practices for writing global-ready content.
Here are four best practices t
Medical device companies creating technical documentation, clinical / post-marketing reports, labeling and quality documentation with increasing regulations and recent MDR/IVDR compliance in mind may find that their traditional approaches to these types of content may no longer work. The old document-based approach of creating plans/reports continuously and technical documentation does not lend itself to control of regulated content, multichannel publishing, and efficient and accurate change
Commercialization of new drugsrequire careful navigation through complex regulations defined by Global health authorities. Drug development process needs extensive collaborations with internal & external stakeholders, co-ordination with cross functional teams like R&D, QA, clinical research, safety, manufacturing, supply chain, marketing, and so on. At every phase of development process, companies are responsible for the safety and efficacy of their drug for human use. This needs a co
The changes the regulation brings companies need to already be reviewing their current processes, systems and supporting infrastructure for clinical trial applications and operations. They need to do so in every changing regulatory environment where Clinical Trial and related data is being ever more scrutinized.
This paper provides a synopsis of the new regulation
- Insights on timing
- The advantages of preparedness.
- The impact that Brexit