Speed regulatory compliance with continuous publishing

Life science organisations are increasingly focusing on how they can improve the speed and efficiency of their operations

Many are moving from multi-step serial processes to more continuous, automated ones. Drug manufacturing is the perfect example of this, with life science companies incorporating activities such as inline analytical testing to enable seamless, continuous manufacturing, resulting in operations that are faster and higher quality.

Another area in which adopting process improvement can deliver real transformative benefits is in regulatory, whereby dossier publishing can be faster, more efficient and more effective.

Moving to continuous publishing

Currently, submitting information to regulators is a disjointed process that spans multiple systems, contributors and separate tracking spreadsheets. Continuous publishing streamlines this entire process. Submission development is typically a serial process.

The process starts with a submission plan. Individual documents are then authored and reviewed. Once all the documents within a module are approved, publishers add PDF navigation before compiling and validating the submission until it is clean for delivery.

At least five systems are typically involved — a document management system, a publishing tool, a validation tool, a file share and a viewing tool — not to mention one or more spreadsheets for planning and tracking. Gaps across systems and manual processes potentially introduce inefficiencies and delays, with documents moving in and out of these systems as the process happens.

With continuous publishing, the entire process is done in a single, unified system. Submission planning information, such as the type of submission, designated countries, expected submission dates and more are managed alongside the documents. A related plan is developed to specify and track required content, along with links to existing and future documents.

Traditional publishing activities, such as adding bookmarks and navigation, are moved upstream with content creation. Other activities — including hyperlink testing, XML compilation and validation — are automated and run behind the scenes from the beginning.

A workflow-driven process moves documents and the plan itself through lifecycle states, allowing the submission plan to become a publishable structure. With every step connected, there is real-time tracking for clear visibility across the process, up to and beyond submission.

The benefits of continuous publishing

Continuous publishing makes the submission process significantly faster and easier for regulatory teams. It can turn weeks of work into days, and hours of tracking or searching into seconds.

Quality is built into the process with validations performed automatically and behind the scenes from the start; any issues are identified earlier, when they are easier to fix. With publishing activities happening throughout content development, once the last document gets approved, relatively little time is needed to submit.

Consolidating the publishing and document management capabilities into a unified regulatory information management (RIM) platform is what makes continuous publishing possible.

By eliminating the document transfer, you no longer need to wait for final approval before the publishing process can begin. Instead, you can author and publish documents in tandem. Unified RIM opens new, more productive and efficient ways of operating with authors and publishers working on the same documents at the same time.

Moving to a continuous model has the power to transform regulatory publishing. By unifying systems, it removes complexity and makes the process seamless, eliminating delays, particularly at the end of the process. It increases visibility and makes the jobs of regulatory teams easier, supporting them through an environment that improves performance and quality.

Companies