Have Confidence in Your Data
As Bio/Pharma Advances, So Must Our Data Integrity
Bio/pharma development and manufacturing processes have been evolving at a rapid pace. The pharmaceutical industry has grown from simple aspirins to IV delivery, antibiotics and, most recently, cell and gene therapy. Products are more complex, tailored and varied than ever and the associated amount of data is growing – which requires a new level of attention to detail. As covered in the Life Science Leader article “How to Avoid Data-Integrity Woes in Pharma”, the situation is exacerbated by data dispersed among various proprietary systems and disparate teams across global manufacturing networks. This framework also complicates compliance with the FDA’s requirements for data integrity in development and manufacturing operations.
“With the advent of personal medicines and unprecedented scrutiny in drug manufacturing and drug product quality, the industry needs to improve data integrity and operational transparency,” commented Robert Di Scipio, CEO of informatics software company, Skyland Analytics.
While data integrity is critical to building confidence in the supply chain and product quality, as well as meeting FDA compliance obligations, many organizations remain highly reliant on spreadsheets, manual data entry, paper records and email which create numerous opportunities for error and can result in FDA warning letters, fines or recalls.
Large life science companies who have invested in systems to manage development and manufacturing data may experience integrity challenges as systems tend to proliferate with acquisitions, new IT staff and evolving user requirements. This problem is further exacerbated as in-house built solutions age due to technology obsolescence.
