TSI provides a complete range of particle countering instrument solutions for classifying and monitoring cleanrooms that are used by national and standard laboratories worldwide.
“Data integrity” refers to the completeness, consistency and accuracy of data. It is a top priority of large pharmaceutical manufacturers and regulatory inspectors worldwide increasingly focus on it.
One might assume this is a result of a change in Good Manufacturing Practices (GMPs), but basic data integrity requirements have always been an integral part of regulations.
What has changed is the way regulatory agencies perform inspections, making the review of data management practices key.
This has led to a surge in audit findings associated with records and record keeping.
Not surprisingly, pharmaceutical manufacturers are looking for ways to simplify compliance.
Fortunately, regulatory agencies and professional organisations have released numerous guidance documents in recent years.
Many guides reference “ALCOA+.” ALCOA+ identifies the characteristics data must have to ensure data integrity. The acronym stands for: Attributable, Legible, Contemporaneous, Original and Accurate, with Complete, Consistent, Enduring and Available covered by the “+”.
Like any other GMP test, airborne particulate testing must follow ALCOA+ principles, but compliance can vary depending on risk.
TSI Portable Particle Counters offer the flexibility to meet a range of data integrity requirements.
Whether enabling built-in printer capability or operating in highly automated data integrity mode, TSI particle counters help our customers comply with ALCOA+ principles and FDA 21 CFR Part 11 requirements for electronic records.