April 15, 2011

When should I start better managing my development artifacts?

A look at a common question of start-up medical device and other regulated companies that want traceability, but don’t know when to start. I'm often asked, "When is the best time to get my development artifacts in order?" The short answer is there isn't a best time. But, the better question is, "How can you afford to wait?" In the life sciences sector, companies must prove that good processes were used in the development of a product. If you know you don't have good processes, or you have a lot of manual processes, it's likely you need to get your development artifacts in order now. Many times, prospects want traceability right before a product launch or premarket approval. While Seapine Software can help migrate some of this data, it would have been much easier to do it earlier in the product development lifecycle because the prospect would have gained insight into the following areas:
  • Next steps
  • Missing tests
  • Unresolved issues
  • Proactive notifications
  • Historical records
Waiting until an FDA 483 or a warning letter is issued is obviously waiting too long, but these situations usually create a sense of urgency to get artifacts in order from the top down. Another question that I’m asked about getting product development artifacts in order is, "Who is responsible and how do I get a consensus decision?" You're unlikely to get a consensus decision because nobody wants more control or sees the bigger picture around traceability. The decision should be from the top down in the organization because traceability is the responsibility of the entire organization. If each group does their own thing and there is little automation, there is likely not good communication or processes between groups. If compliance is driving the decision for better traceability, sometimes the other groups don’t see the benefits of automating or streamlining these processes, which are:
  • Data availability for daily tasks
  • Better communication of changes
  • Reduction in manual entry and human error
  • Better risk analysis
  • Actionable traceability matrix
  • Greater insight for management
  • Electronic signatures only at key points in the process
  • Assurance of good process
All of these benefits assist in daily efficiencies and ensure compliance measures are met. There is no more scrambling around to try and find the latest information or questions about why was I the last one to know about this issue or change. It all comes down to doing things right as soon as you can, because if you don't, you won't likely bring a product to market in the near future. To learn more, I recommend downloading our Traceability Toolkit. “Part 1: Recognizing the Danger Signs of Weak Traceability” describes six symptoms that indicate your traceability may not be as strong as you think, and “Part 2: Six Exercises to Strengthen Traceability” has exercises to help determine how ready you are to prove traceability and if you can afford to wait to get your development artifacts in order.