For biopharmaceutical organizations working with contract labs, it’s important to consider how data and methods will be transferred and how generated data will be managed so that it meets data integrity and compliance requirements.
Analytical methods transfer. Data integrity. A changing and more stringent regulatory landscape. All this, and more, impacts productivity in upstream and downstream biopharmaceutical processes. How is Waters looking to help address development challenges for biologics and biosimilars?
Halting a chromatographic analysis where the system is not performing correctly or when another error is evident in the separation is a valuable and scientific way to avoid creating unusable data that needs to be subsequently invalidated following a defined analytical lab error/result SOP. But what do you do with that orphan data?
Removing the ability for individual users to either delete data or to disable audit trails is expected to be both implemented and validated for data integrity. But when changes are required, what editing tools should be accessible to an analyst?
Orphan data may exist for any number of scientific or operational reasons, but in today’s environment – until the regulators trust the companies again – each piece of orphan data is suspect and may contain evidence of data tampering. So can you delete it?
3 signs that you need to create a culture of compliance As mentioned in my first post on data integrity, people trust that companies create safe, quality products and rely on data to support that belief. But most product data, especially laboratory testing, should be designed to catch studies, batches, or test samples that fail…
What can happen when a laboratory doesn’t know that its electronic records leave a digital trace that the FDA can follow.
Behind analytical data are humans – with pressures, emotional and personal needs to provide the best possible data for the biggest impact, personal pride, or simply a desire to make their lives easier. Do human or cultural factors affect scientists in regulated laboratories or operators in manufacturing areas?
It’s not just about compliance any more. You’ve seen it in the headlines: 79% of Warning Letters issued by the FDA cite data integrity issues in 2016 (up from just 26% in 2013). But what does this actually mean? Where do these figures come from? Isn’t this just in India or China? What was traditionally…