QuipAssist tracks calibration schedules for every instrument in the laboratory — with calibration intervals configured per instrument based on manufacturer requirements, regulatory standards, and quality system specifications. Calibration certificates from accredited calibration providers are stored in each instrument’s asset record with expiration date tracking. Advance reminder notifications fire at configurable intervals before each calibration deadline — typically 30, 14, and 7 days before expiry. When calibration certificates expire, the instrument can be flagged as out-of-calibration in the system with a status indicator visible to all users who access the instrument record. The complete calibration history for each instrument is permanently retained and exportable for any FDA inspection, quality audit, or regulatory submission supporting documentation request.

QuipAssist stores IQ, OQ, and PQ documentation for each qualified instrument in the instrument’s asset record — along with qualification dates, qualification scope, and any conditions or restrictions identified during qualification. Requalification schedules are configured for instruments that require periodic re-qualification or that are moved, modified, or used for applications beyond their original qualification scope. The complete qualification history for each instrument is accessible instantly for any FDA or GLP inspection document request. Note: GLP and GMP equipment qualification documentation requirements vary by regulatory authority, study type, and application — always work with your quality assurance team and regulatory affairs counsel to confirm that your specific qualification documentation program meets all applicable requirements.

QuipAssist’s IoT temperature monitoring is designed to produce continuous, timestamped temperature records that meet the documentation completeness and integrity standards that 21 CFR Part 11 and equivalent regulations require for electronic records. The temperature logs are generated automatically from sensor readings — not from manual entry that could be altered — and are retained with timestamps that reflect actual measurement times. Note: 21 CFR Part 11 compliance for electronic records involves specific technical and procedural controls beyond temperature logging alone — system validation, audit trail requirements, access controls, and record security. Always work with your quality assurance team and 21 CFR Part 11 compliance counsel to assess whether your specific QuipAssist implementation and configuration meets the applicable requirements for your laboratory operations and regulatory context.

QuipAssist supports FDA inspection preparation by maintaining complete, searchable, instantly accessible maintenance and calibration records for all laboratory equipment — so that when an FDA inspector requests equipment maintenance records, calibration certificates, or qualification documentation during an inspection, the facility can produce complete, organized records in minutes rather than hours. Pre-inspection preparation using QuipAssist includes generating calibration compliance reports showing all instruments with current calibration, flagging any instruments approaching or past calibration deadlines for immediate remediation, and producing equipment service history exports for any instruments likely to be examined during the inspection. The systematic, documented maintenance program that QuipAssist enables is itself evidence of quality system compliance that inspectors evaluate during their overall assessment.