ಸ್ತಂಭ 01 · ಕಂಪ್ಲೈಯನ್ಸ್ ನೇಟಿವ್
ಪ್ರತಿ ಹಂತಕ್ಕೂ ಒಂದೇ ವಿಷಯವನ್ನು ಚೆಕ್ ಮಾಡುವ ಒಂದು ರೂಲ್. ಪ್ರತಿ ಬಾರಿಯೂ.
- ಅಪ್ರೂವ್ ಆಗದ ಆ್ಯಕ್ಷನ್ ಎಂದಿಗೂ ಸೇವ್ ಆಗುವುದಿಲ್ಲ.
- ಪ್ರತಿ ನಿರ್ಧಾರಕ್ಕೂ ಸಹಿ ಮತ್ತು ವಿವರಣೆ ಇರುತ್ತದೆ.
- ಆಪರೇಟರ್ಗಳು ಯಾವಾಗಲೂ ಪ್ರಸ್ತುತ SOP ಅನ್ನೇ ಬಳಸುತ್ತಾರೆ.
UNITED STATESCONTROLS
FDA 21 CFR Part 11
FOOD & BEVERAGECONTROLS
FSSAI Schedule 4
COSMETICSCONTROLS
ISO 22716
NUTRACEUTICALSCONTROLS
21 CFR Part 111
MEDICAL DEVICESCONTROLS
ISO 13485
- Audit trails retain the previous value.
- The new value stays with the change.
- Every change identifies its author.
- Timestamps preserve the sequence of events.
- The reason stays with each change.
- Hash chains connect audit entries.
- Specifications stay in the device file.
- Manufacturing and packaging records join the file.
- Labelling and servicing information remain connected.
- Design inputs and outputs stay together.
- Reviews retain their supporting evidence.
- Verification and validation remain traceable.
- Design transfer stays in the development file.
- Design changes reach the risk file.
- Affected released records stay linked to the change.
- The risk file retains each control measure.
- Controls link to the process steps that implement them.
- Roles determine access to each record.
- Permissions extend to individual fields.
- The maker cannot act as checker.
- The system enforces separation of duties.
- Every approval identifies its signer.
- Each signature records its time.
- The meaning stays with the signature.
- UDI recorded per device or batch, with GUDID and EUDAMED attribute changes tracked on a 30-day clock
- Labelling and packaging examination documented before release, per Section 820.45
- Device records retain batch and unit identity.
- Material genealogy follows the device.
- Process genealogy stays with production records.
- Complaint intake with prescribed data elements and the reporting clock attached
- Vigilance and MDR reporting routed by jurisdiction against the correct deadline
- Servicing records held to the same controls as production records
- Management reviews retain their records.
- Internal and supplier audits stay access-controlled.
- Audit records follow retention controls.
- Supplier qualification retains audit history.
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