New Data Integrity Draft Guidance – Are You Ready?
The move to electronic data collection, analysis, storage, and reporting continues to grow in the pharmaceutical and life science industries. Software is becoming more robust with features and functionality enabling labs to become more paperless. But, regardless of where you are on your quest to reduce the use of paper in your lab, the responsibility for knowing where your data are at all times and whether they are accurate and reliable is paramount for being compliant. In April of this year, in response to increased concerns about electronic data manipulation and integrity overseas, the FDA released “Data Integrity and Compliance with CGMP, Guidance for Industry” to help US companies ensure their electronic data remains Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) while using computerized systems. How does your company address data integrity and are you ready to comply with the new FDA Guidance? [Read More]
