Software is a significant investment, whether you are coding your own, purchasing for in-house installation, or accessing it on line. This is especially true for FDA regulated companies, because you need to meet compliance requirements for the software that tracks these activities. This must be balanced against the risks of not having software. The tracking method a company uses for these operations is part and parcel of the overall strategy for compliance. As companies grow, they balance the risks of staying with non-qualified systems against the risk of non-compliance. Below are some 483 observation summaries reported by the FDA for drug, medical device, and/or biologics companies based on 2014 inspections:
- Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance.
- Equipment and utensils are not [cleaned] [maintained] [sanitized] at appropriate intervals to prevent [malfunctions] [contamination] that would alter the safety, identity, strength, quality or purity of the drug product.
- Records of the [calibration checks] [inspections] of automatic, mechanical or electronic equipment, including computers or related systems are not maintained.
- Procedures describing the calibration of instruments, apparatus, gauges and recording devices are [not written or followed] [deficiently written or followed].
- Laboratory records do not include complete records of the periodic calibration of laboratory [instruments] [apparatus] [gauges] [recording devices].
- You did not document the [calibration] [inspection] [checking] [maintenance] of laboratory equipment.
- Schedules for the adjustment, cleaning, and other maintenance of equipment have not been [adequately] established.
- Equipment used in the [collection][processing][compatibility testing][storage and distribution] of blood and blood components is not observed, standardized and calibrated with at least the frequency required.
The benefit of using a qualified software system is that it makes it easier to maintain compliance, which is good practice, and a requirement. Experience has shown that spreadsheet or paper based schedules can be difficult to maintain and provide limited traceability. GxPReady Suite has been designed to address these issues with a flexible, simple, low cost, 21CFR11 compliant approach that companies can transition to when they are ready to move on from spreadsheets and paper schedules.