Robust Cleanroom Routine Environmental Monitoring

The FDA’s 21CFR part 11 guidance on the use of electronic records for data retention or submission is clear. With manually implemented Standard Operating Procedures (SOP) for cleanroom routine environmental monitoring and manual transcription of the test results still common practices the resultant opportunities for human error raises concerns over the integrity of the data in the final electronic record, no matter how safely the final record is stored. This paper describes how Quality Control instruments can be optimized for pharmaceutical use, helping to improve the integrity of the data in the final electronic record.