Built to support your 21 CFR Part 11 compliance.
Time-stamped audit trails, e-signatures linked to records and role-based access, delivered with the documentation you need to validate them.
Every record is tamper-evident and every action is logged. Validation for your intended use stays with your team; DROME provides IQ/OQ/PQ documentation to support it.
Requirement by requirement.
Click each regulation to see how DROME addresses each requirement specifically.
21 CFR Part 11Electronic Records & Signatures
Requires that electronic records used to meet FDA requirements be trustworthy and equivalent to paper records.
Immutable audit trail with cryptographic signing, role-based access control and electronic signatures linked to each record, with the documentation for your validation.
What does 21 CFR Part 11 require for electronic records?
Part 11 requires validated systems, accurate and complete copies of records, access limited to authorized individuals, time-stamped audit trails (§11.10) and electronic signatures linked to their records (§11.50 and §11.70). DROME provides these controls and the documentation for validation, which remains the customer's responsibility.
21 CFR Part 211Current Good Manufacturing Practice (cGMP)
Establishes minimum requirements for methods, facilities, and controls used in manufacture, processing, packaging, and storage of drug products.
Automated calibration tracking, deviation management with CAPA workflows, and complete warehousing condition records with sub-minute granularity.
What does 21 CFR Part 211 require for storage and equipment?
Part 211 requires automatic equipment to be calibrated and checked under written procedures (§211.68), deviations to be recorded and justified (§211.100) and drug products to be stored under appropriate temperature, humidity and light (§211.142). DROME records storage conditions and tracks calibrations and deviations.
USP <1079>Risks and Mitigation Strategies for the Storage and Transportation of Finished Drug Products
Guidance on reducing risk in the storage and transport of finished drug products, including temperature monitoring and mapping, so identity, strength, quality and purity are maintained.
Automated temperature mapping reports, continuous calibrated monitoring with configurable alarms, and documented excursion response workflows.
What does USP <1079> recommend for storage and transport?
USP <1079> guides risk reduction in the storage and transport of finished drug products through temperature mapping, calibrated monitoring devices and documented excursion response. DROME produces mapping reports, monitors continuously and records every excursion.
FDA GuidanceComputer Software Assurance
FDA guidance for production and quality system software. Assurance effort scales with the risk of each function, with less scripted paperwork.
DROME provides a risk assessment of its software functions and supplier test evidence you can reuse in your own assurance activities.
What changes with the FDA Computer Software Assurance guidance?
The guidance calls for risk-based assurance: high-risk functions get scripted testing and the rest can use unscripted testing, with enough records to show what was done. DROME provides a risk assessment of its functions and test evidence the customer can reuse.
Ready to simplify your compliance?
Every record is tamper-evident and every action is logged. Validation for your intended use stays with your team; DROME provides IQ/OQ/PQ documentation to support it.