quality.document.management.life.sciences.trends.2016.jpgLife Sciences quality and manufacturing organizations face three critical industry forces – increasingly stringent regulation; globalization; and virtualization of supply networks. 

These trends, along with changing user preferences, create new challenges for compliant document management including increased complexity and the need for collaboration.

Why? There are several key factors contributing to the demand for today's competitive Life Sciences organizations to embrace quality document management solutions and innovative strategies. 

  • Industry pressures are prompting Life Sciences organizations to adopt new business models, enter new and emerging global markets, and expand alliances and partnerships in order to deliver high quality, safe drugs to market faster to improve health and well-being at a lower cost.
  • To achieve these goals, life sciences organizations are becoming more strategic in how they manage manufacturing production to ensure that it is lean, efficient and uninterrupted – and at the lowest possible cost.
  • Many life sciences companies have found that an enterprise content management solution designed specifically for quality organization enables them to efficiently create and control quality and manufacturing documents, automate workflows, and ensure compliance with good manufacturing practices (GMPs).

Life Sciences organizations are looking to gain centralized, standardized, and harmonized control over — and visibility into — all quality and manufacturing documents.

quality.document.management.life.sciences.2016.jpgTrending: What Do You Know About Title 21 CFR Part 11 & Records Management?

The focus for Life Sciences organizations today, in terms of quality manufacturing, is driven by five key goals. 

  1. Streamlining the creation, review, approval and change management of documents governing manufacturing, quality and compliance procedures across the extended enterprise.
  2. Utilizing the DIA industry-standard, out-of-the-box document taxonomy to quickly create documents, and then search, retrieve and use them.
  3. Automating distribution of new, effective documentation internally and externally.
  4. Leveraging flexible lifecycle support for multiple control levels within a single repository.
  5. Linking content across Quality, R&D, eTMF, and FDA Correspondence for consistent, simplified document management and user access.
Today, many Life Sciences companies have an outdated server infrastructure and recognize the need for a fresh start with new servers, new infrastructure, and information architecture capable of meeting greater user demand – with more automation.

Life Sciences organizations are changing the way they develop, manufacture and sell their products. To stay compliant with safety, quality and regulatory standards, Life Sciences quality and manufacturing operations must have quality manufacturing processes in line with GMP, and documentation control processes that describe, specify and record manufacturing and quality activities in compliance with current requirements.

GMP Compliance: Enhance GxP compliance while reducing the time and cost of managing quality documents.

quality.document.management.solution.2016.jpgFailure in either can have catastrophic consequences.

With the realities of quality manufacturing demands in today’s Life Sciences market, a solid document management strategy is essential to avoid devastating business events. 

An upgrade to a newer solution from legacy quality and manufacturing systems can help today’s Life Sciences organizations implement a world of enterprise content management applications at a rapid rate, avoiding the chance of a catastrophic issue in this age of digital transformation.

With certainty, the push for productivity, information integrity, agility and localization and right-to-left support is driving the Life Sciences market to research, invest and engage in intelligent, advanced content management upgrades and configurations – a trend likely to increase greatly as 2017 approaches.

Paragon's Troy Carter, Principal Consultant, Life Sciences, contributed to this blog.