July/August 2018 • www.cemag.us 11
• All pertinent data should be included in the
record (even if it is undesirable).
• Passwords should not be shared between personnel.
• All original records should be stored and kept
safely on non-volatile media.
• Records should never be discarded or destroyed.
Everyone involved in the process, no matter their
position, is responsible for upholding data integrity.
Data Integrity is a significant component of
the Quality Management System, and inspectors around the world have made it very clear
that good intentions are no defense against
The pharmaceutical industry must strongly consider any preventive or corrective action
to improve product quality through an honest, ethical approach to data collection and
1. FDA. (2006, June 30). The History of Drug
Regulation in the United States.
2. PharmaCompass. (2017, January 19).
2016 — A Year of Data Integrity Issues and
Pharma Non-Compliances. Retrieved from
Retrieved from https://www.fda.gov/ICECI/
4. MHRA. (2016, April). MHRA GMP
Inspection Deficiency Data Trend 2016.
Retrieved from https://mhrainspectorate.
5. FDA. (1997, March 20). Title 21 of the Code
of Federal Regulations Part 11.
Retrieved from https://www.ecfr.gov/cgi-
6. South, G. (2018, February 26). Ensuring data
integrity through ALCOA. Retrieved from
7. European Commission, EudraLex. (2011,
January). Annex 11: Computerised
Retrieved from https://ec.europa.eu/
8. FDA. (2016, April). Data Integrity and
Compliance with cGMP Guidance for
Industry (Draft Guidance). Retrieved
Daniele Pandolfi is the Global Product Specialist,
Aerosol, in Particle Measuring Systems’ Life Science
Division. He has over 10 years’ experience in particle counter instrumentation and cleanroom contamination control,
building close customer relationships. Daniele helps customers to solve their cGMP issues. www.pmeasuring.com
We’re so confident in the reliability of our laser
technology inside our 0.1 μm particle counters
that we’re offering the industry’s best laser
See us at SEMICON West, July 10-12, Booth 843
or visit www.tsi.com/semi
Aero Trak® 9110
Aero Trak 7110