Amplexor in Pharmiweb

A lack of structured authoring in life sciences has limited companies’ scope to infuse regulatory processes with efficiency. But there’s scope to change that now, says Amplexor’s Romuald Braun. In engineering-based industries, use of structured authoring – routinely populating documents with approved information components - is second nature. By contrast, life sciences has muddled through with simple office-style content tools for generating routine operational and regulatory documents.

This has meant that teams have had to start from scratch each time a new or updated document is needed – finding the right data all over again, and assembling it as required. As well as being laborious, this approach is error prone. But it has been hard to address these practical constraints before now, due to departmental information silos and variances in content formats and practice.