How is Pharmaceutical
Compliance Software Used?
Pharmaceutical agencies face pressure for every turn. Whether that’s from sanctions from regulatory agencies like the European Medicines Agency (EMA) or the Food and Drug Administration (FDA) or the looming threat of reputational damage — continuing to innovate, develop new products for multiple markets, grow your business and maintain compliance is a mammoth undertaking. You need a reliable tool that provides a single source-of-truth for creating, writing, and approving content within an optimized and efficient workflow.
Pharmaceutical regulatory compliance software harmonizes assets across locations, supporting better workflows, improved collaboration and quicker editing and approval cycles. Additionally, you can feel confident that you are providing the general public with pharmaceutical ingredients that are sufficiently tested and are likely to enhance their quality of life.
Make no mistake: compliance is not something you can rubber stamp. There are staggering repercussions for failing to adhere to the highest quality and safety standards, the risk to human health being the ultimate responsibility to bear.
You need pharmaceutical compliance software that manages assets throughout your entire content estate, regardless of format, location or channel.
Only with a pharma regulatory compliance solution provider can you reap the benefits of productivity and increased efficiency, while constantly improving patient safety.
Benefits of Compliance Software
In The Pharma Industry
Developing medicines requires being able to share knowledge across channels easily. Medicine development is completed across operations, platforms, and locations, with a content repository that can include disparate files like text, tables, properties, pictures, videos and graphics.
It is not a small feat to achieve compliance for regulation-heavy Structured Product Labeling (SPL) across channels while avoiding the pitfalls of human error and mistakes. You need pharmaceutical regulatory compliance software calibrated to meet these unique needs.
Achieving compliance starts with Quark Publishing Platform (QPP) NextGen and its structured authoring plugins Quark XML Author and Quark Author. These plug-ins auto-generate XML metadata to let you create reusable content building blocks to save time and manage content validation across the whole content ecosystem. Quark XML Author can be used within the familiar environment of Microsoft Word and functions on mobile devices or offline use.
Quark Author uses a standard web browser and gives an alternative option to using Microsoft Word. Content blocks utilize a single source-of-truth that automatically updates when the original content changes. Users can also use these tools to migrate their existing files to XML-based content components.
It’s no wonder why so many worldwide leaders in the pharma industry, including those in BioTech, clinical research organizations, generics, healthcare, large pharma, medical devices & equipment, pharmaceuticals, and more, depend on Quark.
There are unlimited advantages to pharmaceutical compliance software. Some key benefits include the following:
- Managing critical content in one central repository
- Safeguarding compliance even in the face of nuanced situations
- Accelerating collaboration and time to market for medications
- Eliminating errors and barriers that add to cost
