Data Integrity Trends and How They Impact Validation. Erik Muegge, M.S., PMP Abbott Diagnostics Division IVT Dublin Validation Week 2016

Transcription

1 Data Integrity Trends and How They Impact Validation Erik Muegge, M.S., PMP Abbott Diagnostics Division IVT Dublin Validation Week 2016

2 Agenda History what got us here Current thoughts from the FDA How big is the focus trends How do we adjust our validation practices

3 Deep Thoughts for the End of the Day When you type in Validate for clipart in PowerPoint you get: Those make sense (mostly), but what in the world is Microsoft thinking when they retrieve some of these?

4 History Loss of 1984: Laws issued allowing for quicker approval of generic drugs Trust : Data falsification, bribes, data issues, etc. 1989: FDA and lawmakers refocus on generics and resulting problems since : FDA announces Office of Criminal Investigations 1992: Law passed including debarment 1993: Nine companies (since 1989) and more than 30 employees convicted of fraud One was former head of generic drug company and sentenced to 5 years and fine of $1,250,000 USD. 1997: 21 CFR 11 effective Early 2000: FDA speaks at conferences emphasizing Part 11 is just another way to look at data integrity industry was reacting differently 2003: Part 11 enforcement discretion 2009: refocus on Part 11 in inspections 2010: Compliance Policy Guide has data integrity as one of the 3 areas of focus 2010 today: Increasing trend of data integrity findings

5 FDA is Inspecting for Data Integrity Data integrity is not specific to validations only Data integrity is part of FDA training The CDER Compliance policy guide includes data integrity as a specific objective of Pre-Approval Inspections (PAI))

6 FDA is Inspecting for Data Integrity Compliance Program Guidance Manual has 33 instances of integrity

7 Recent FDA Presentations June 2014: Brian Hasselbalch (FDA) presented in part on data integrity September 2014: Tara Bizjak (FDA) includes same material at a meeting with industry October 2015: Karyn Campbell (FDA) includes same material at an IVT conference As we go through this, we all need to be thinking How does this impact how I do validation (and other functions)?

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29 It Is Not Just Theory They are Doing What They Say From the Gold Sheet (Oct 27, 2015), Data Integrity Inspections Go Global Karyn Campbell s Oct 2015 IVT Presentation 20 Warning letters related to data integrity (Jan 2014 to Sept 2015) Ron Tetzlaff (former FDA and current Corporate VP Parexel) summarized at Sept 2015 IVT Data Integrity Conference that from Jan 2012 through July 2015: 71 GMP warning letters issued. 68% included issues related to data integrity. 48 warning letters related to data integrity included 53 manufacturing facilities in 18 countries (India the most sited)

30 Data Entry How Do We Adjust Our Validations It is not just about functionality, know how your system or process is supporting the regulations. Review For example in an automated Queries compliant indicators, handing system Signatures Sec (a) Complaint files. Each manufacturer shall maintain complaint files. Each manufacturer shall establish and maintain procedures for receiving, reviewing, and evaluating Time stamps complaints by a formally designated unit. Such procedures shall Std. ensure that: 1) All complaints are Forms processed in a uniform and timely manner; 2) Oral complaints are documented upon receipt; and 3) Complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA Status under part 803 or 804 of this chapter, Medical Device indicators Reporting. and tracking

31 How Do We Adjust Our Validations Look at the process your system is supporting Ensure your requirements reflect not only functional but regulatory expectations and test to those requirements. Be mindful of regulatory and industry trends Use your validations to build value into the process, not just check a box Use it to establish confidence in the system/process

32 So How Do We Adjust Our Validations? Keep all validation data (once the validation has begun) Once the testing begins, no unofficial testing If people are testing into compliance, the validated system must be able to show that Turn on audit trails During execution of a validation package, record data contemporaneous with execution Design your validations protocols to produce objective evidence Keep raw data even if transcribed keep original Do not share passwords When reviewing validation packages, think like the FDA. Does it look right, does the data support the test case and does it support the overall package (not suspicious) Protect the data and ensure it is being kept on proper locations Access controls: Ensure only authorized users can access both data but also functions and settings (limit access to only the job function) All of the controls (e.g. release of data/lot) are working as intended Data integrity is of course a focus on the data, but also the process that is producing the data. Train employees on proper data handling and emphasize that everyone is responsible for data integrity

33 Finally The FDA Does Have a Sense of Humor (The Glass is Half Full)

34 Questions?