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Tag: Medical Information

Pharma lab technicians work with confidence, supported by governed, traceable Quality and CMC content that helps demonstrate compliance through review, audit, and lifecycle change.

How a leading biopharmaceutical company upgraded its content creation process

Deviating from familiarity can make people feel uncomfortable. At the same time, humans are adaptable; have you ever protested a software update for an app on your phone? You likely grumbled a little bit, but before you even realized it, you were moving on with your life, if not appreciating the improvements.

Pharma professional uses an outdated document-based system, struggling to maintain authoritative, traceable regulated content as information changes across the lifecycle.

How SCA can extend the lifespan of Life Sciences content

Imagine your team of medical information writers has spent days, months, maybe even years authoring, reviewing, and updating drug development content in a program like Microsoft Word. This process involved the writing itself and multiple rounds of reviews, as well as sifting through hundreds of paragraphs to update a single sentence and countless hours reconciling various versions.

Global technology company supporting pharma teams with structured content authoring, enabling governed, reusable content to remain authoritative and traceable across regulated lifecycle change.

Don’t get lost in translation: How SCA simplifies Pharma authoring complexities

For many Life Sciences organizations, a leading challenge — on top of a very long product development cycle — is that the work is completed across departments, time zones, and even languages. Many pharma content teams must work collaboratively using tools that don’t support an efficient exchange of information, especially when you factor in translation and localization.

Pharma leaders express confidence in their new structured content authoring platform, using governed, reusable content to maintain authority and traceability through review, approval, and lifecycle change.

Can your documentation solution flex with your organization?

For Pharma businesses of all sizes, the right tools can enable efficiency, collaboration and effective use of available resources. When it comes to medical information writing teams, structured component authoring (SCA) is a solution with great promise for a complex authoring process. However, not all SCA platforms are designed to flex to match the needs of all organizations.

Pharma leader follows document approval controls, verifying authorized access, review history, and traceability to maintain governed regulated content through lifecycle change.

Could one documentation solution save you time and money

Use this checklist to discover if it\’s time to move to a more efficient authoring solution. Structured component authoring (SCA) can help your organization save valuable time and resources by authoring, reviewing, updating and publishing content — all from one integrated platform.

Webinar announcement on medical affairs

Behind the scenes: Why medical information authors need SCA

We believe that Life Sciences organizations need a centralized platform for medical information authoring, so we’re sitting down with experts to examine some of the greatest inefficiencies in the industry. To kick off our series, we interviewed Docuvera Medical Affairs SME Kenneth Galloway to hear what challenges writers face and learn how structured component authoring (SCA) can streamline the process for the whole organization.

Illustration of connected octagons represents relationships between governed structured content components, preserving authority, metadata, and traceability as regulated information is reused across the lifecycle.

7 necessities for structured component authoring, part 2

For Life Sciences organizations, the medical authoring process requires agility to comply with complex documentation requirements. From dozens of authors and strict regulations to multiple review cycles, you need a solution that moves with your projects — a flexibility that might be missing if you still depend on programs like Microsoft Word for your content development and publication.

Illustration of connected lines represents relationships between governed structured content components, preserving authority, metadata, and traceability as regulated information is reused across the lifecycle.

7 necessities for structured component authoring, part 1

For Life Sciences organizations, agility in the face of regulatory change is essential. In the complex medical authoring process, content development and publishing should be easy and intuitive, and not get in the way of your groundbreaking work.

Life sciences leader reviews regulated documents on a monitor, verifying authoritative content, approval history, and traceability to support lifecycle change and regulatory responses.

Do it write: from implementation to authoring in no time

When organizations invest in new platforms and technology, it’s a big deal. From making the actual purchase of the tool to using IT resources to getting everything up and running, it can be a major lift — and a major expense.

Pharma team reviews regulated documents together, verifying authoritative content, approval history, and traceability as information moves through review and lifecycle change.

3 tips to efficiently manage the internal and external medical writing process

For authors in the Life Sciences industry, there are typically many moving parts — and many people working simultaneously — on any given project. Getting people on the same page is critical when you are creating medical documentation. And, this is even more of a challenge when you have a combination of internal and external teams collaborating on a project.

Legacy copy-and-paste process shows regulated content duplicated across documents, making it difficult to preserve authoritative statements, traceability, and control as content changes across the lifecycle.

SCA: Authoring that feels familiar (but better)

Medical authoring has long relied on programs like Microsoft Word, and with good reason. The desktop publishing platform is user-friendly, universally familiar and has hardly changed in the three decades since its first release.

Global pharma team review an outdated document-based system, searching for authoritative, traceable information needed to answer regulatory questions and manage lifecycle change with confidence.

SCA: A solution that works from author through IT

IT teams are the unsung heroes of every enterprise organization. From securing endpoints, maintaining the network and troubleshooting, to executing new technologies that can change the course of business, IT is busy. And, like many departments, IT is often under-resourced and overworked. The last thing they want is to undertake launching a solution that requires extensive support or barriers to implementation.

Pharma leaders examine information closely, searching for authoritative, traceable evidence needed to answer regulatory questions with confidence.

What to look for in structured component authoring solution

In the Life Sciences industry, anything that can help keep your organization agile in the face of regulatory change is essential. Content development and publication decisions should be easy to make, leaving you free to focus on more important things. If you know what to look for, a structured component authoring solution can help.

Pharma technology leaders evaluate a content governance approach designed to preserve authoritative, traceable regulated statements as content changes and is reused across the lifecycle.

The most important benefits of structured component authoring

Reliable, compliant documentation is essential, but creating, reviewing, and publishing that content takes time and human resources. With Docuvera’s intuitive SCA solution, your organization can reap the benefits of a cloud-based documentation system designed exclusively for Life Sciences.

Docuvera for Medical Information

Download the data sheet to see how using Docuvera’s component authoring approach of authoring, reviewing and updating discrete blocks of content only once, the creation of medical letters can be improved.

See what structured component authoring can do for you.

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