Accredited Laboratories that operate under the guidelines of ISO17025 or are governed by other agencies such as the FDA (Federal Drugs Agency) or EPA (Environmental Protection Agency) are required to satisfy analytical instruments comply with appropriate codes and design intentions. Furthermore if using analytical instruments for client applications, R&D, production, or QA/QC operations these laboratories require periodic testing of instruments to verify there suitability and accuracy because performance deteriorates with time.
Regulatory guides require the calibration of equipment at suitable intervals in accordance with an established written program containing directions, schedules, limits of accuracy/precision, and provisions for remedial actions in the event that accuracy/precision limits are not met.
For any equipment used in a GLP/GMP regulated environment there should be a description of what the equipment is supposed to do, what are the required functions and performance characteristics, and there should be documentary evidence that the equipment meets performance criteria. The system description or DQ (documentary qualification) must be current and available for all instrumentation and that documented tests shown to be performed following acceptance criteria which describe the metrics under which the instrument has been measured and validated. In the eyes of accredited laboratory auditors 3 basic rules apply to documentation:
- 1. "If it isn’t written down it didn’t happen"
- 2 "If it isn’t written down properly, we can’t be certain of exactly what happened"
- 3 "If the records aren’t correct and complete, neither is the product or result"
The MicroLab Service Team is committed to providing total support as your trusted partner in satisfying compliance and performance objectives. Since we are most familiar with how the Hamilton and Hirschmann instruments are designed to perform and operate, we can complete equipment qualification and support instrument verification efficiently, while minimizing your risk of non-compliance.
See also:
Qualification (IQ/OQ/PQ)
Validation/Verification