December 1, 2016

Traceability's Importance for Life Sciences Product Development


Product complexity continues to increase in the life sciences industry, making it more important than ever for companies to effectively leverage traceability in their product development process. However, more than half of industry experts surveyed say they are unable to use traceability for more than compliance purposes, according to the 2016 Life Sciences Product Development Survey Report. What prevents them from making better use of this key product development component?

The Importance of Effective Traceability

Effective traceability allows teams to document the life of the product development process, so that every artifact can be easily traced all the way back to the originator of the initial request. Click to download the full report.[/caption] By creating relationships and links between development artifacts, effective traceability allows stakeholders, managers, and regulators to quickly review, from a high level, every action and decision within the product development lifecycle—or drill down to detailed information, as needed. Every relationship and artifact change can be traced all the way back to the original requirement, providing instant visibility into product data. From a compliance standpoint, traceability tracks, relates, and verifies each step and activity within the development process. It helps life sciences organizations better monitor and analyze:

  • Product development projects
  • Verification and validation activities
  • Internally validated IT systems
  • Product approvals

From a business-value standpoint, an integrated product development solution:

  • Improves visibility and collaboration among stakeholders, reducing errors and duplication of effort.
  • Provides managers with timely and accurate information they need to make informed business decisions and keep the development process moving.
  • More quickly defines and mitigates issues and challenges to speed product development.
  • Boosts performance and eliminates wasteful costs by improving efficiency in every area of the development process.

In addition to meeting regulatory compliance, traceability can help companies bring quality products to market more quickly, safely, and profitably. Nearly half of survey respondents (46%) said they are able to leverage traceability to help manage risk, make better decisions, and identify validation coverage, among other key areas. charts_large-_q53

Barriers to Leveraging Traceability

With such significant benefits available, what prevents companies from taking full advantage of traceability? Why are some only using it to check off an item on a compliance list? The 54% of survey respondents who have been unsuccessful in leveraging traceability identified some common barriers, including:

  • It takes too long to find the report. (21%)
  • They have no visibility into relevant data. (18%)
  • The information is often inaccurate. (16%)

The most common barrier they identified, however, was a lack of the right tools and technology (36%). Only 14% of respondents reported using dedicated traceability management tools.   charts_large-_q26   So what are the rest using? Most seem to be assembling traceability reports and matrices manually, using Microsoft Word and Excel. More than two-thirds (67%) said their development process is heavily centered on documents, rather than artifacts; of this group, 85% said they use Word and Excel. Manually performing traceability, however, can be time-consuming and costly, which may explain why these respondents are unable to get more use out of their traceable data.

Improving Traceability Tools

Survey respondents who use dedicated traceability management tools are mostly satisfied with the compliance enforcement, accuracy of information, and access to relevant information their tools provide. The three top areas respondents are dissatisfied with include:

  1. Communication and collaboration (35%)
  2. Automatic change notifications (35%)
  3. Bi-directional linking and traceability (33%)

When asked for their recommendations for improving their traceability management, the leading answer was "better tools."   charts_large-_q40-traceability  

Learn More

The 2016 Life Sciences Product Development Survey Report is now available. To learn more about traceability's benefits, as well as how to improve your traceability, explore our library of white papers and guides.