Improve the Integrity of your Electronic Records

Points of Exposure in the Cleanroom

Cleanroom operators face a unique set of challenges relative to standard operating procedures (SOPs) and particle counting equipment. Manually implemented SOPs for quality testing and data transcription however, remain commonplace in both research and production lab environments resulting in possible data integrity issues in electronic records, no matter how safely the record is stored.

  • Operators manually configure particle counting devices (number of samples, sample duration inputs)
  • Operators key in data for hundreds if not thousands of sample sites
  • Lab personnel calculate and record sample results across different particle counters with different flow rates potentially generating inaccurate results
  • Following a test, operators then manually organize and transcribe ‘paper data’ to electronic format for final review

Each represents an opportunity for error or missing data and is a therefore a point of compliance exposure with consequences ranging from FDA warning letters or consent decrees to plant injunctions and even company closure.

Improve the integrity of your electronic records by ensuring your quality control instruments are optimized for pharmaceutical use. Look for instrumentation capable of pre-configured SOPs and test routines, embedded secure PDF data transfer as well, as one touch sampling and location identification for fast, reliable data transmission. 

Helping researchers and labs maintain compliance with standards