Standard or regulationWhat it expects from maintenanceHow PlantOps360 helps
ICH Q7GMP for active pharmaceutical ingredients
ExpectsEquipment maintained on a schedule with written procedures, calibration of measuring devices, and records of cleaning and use.
Schedule M (revised GMP)Drugs Rules, 1945 (India)
ExpectsPremises and equipment kept in good repair, with planned maintenance and calibration, and records of the work.
WHO GMPGood manufacturing practices for pharmaceutical products
ExpectsEquipment maintained, cleaned and calibrated to a written schedule, with logs.
PlantOps360A full history per asset: what was done, by whom, when and with which parts.
Asset management → 21 CFR Part 11 / EU GMP Annex 11Electronic records and computerised systems
ExpectsAccess control, audit trails of changes and electronic signatures tied to the record.
PlantOps360User roles, change history and e-signatures on approvals. Validation stays under your quality system.
Document management → ICH Q9Quality risk management
ExpectsRisk-based decisions on maintenance and calibration intervals.
Factories Act hazardous-process provisionsSafety in chemical processes (India)
ExpectsSafety equipment and plant in hazardous process units maintained and tested, with records.
This is a plain-language summary for orientation. Always follow the current text of each law and standard, and the rules of your own site and licence.