Sector-specific rigor, without a compliance department.
Clinics, digital health companies, CROs and pharma manufacturers handle patient data and GxP records that regulators inspect closely. Kmetog runs the safeguards those inspections rely on and keeps the proof organised, cycle after cycle.
- ePHI access log review164.312(b)Queued
- Workforce security training164.308(a)(5)Queued
- ePHI encrypted at rest164.312(a)(2)(iv)Queued
- Business associate agreements current164.308(b)(1)Queued
- Contingency plan tested164.308(a)(7)Queued
- Automatic logoff configured164.312(a)(2)(iii)Queued
The pressure is specific. So is the work.
Patient data safeguards
HIPAA expects access reviews, audit logs, encryption and workforce training to be performed and recorded, not just written into policy.
GxP record integrity
Inspectors check that electronic records and signatures are trustworthy, with audit trails and validation evidence to match.
Business associates
Every vendor touching patient data needs a current agreement and a risk review, and the list grows faster than anyone tracks it.
Safeguards run on schedule, with proof attached.
Controls for patient data and regulated records, each with its own evidence trail.
Access to patient data
- ePHI access logs reviewed for unusual activity
- Unique user IDs and automatic logoff verified
- Role changes and leavers reflected in access
Workforce and vendors
- Security training completion tracked per person
- Business associate agreements checked for currency
- Vendor risk reviews linked to renewal dates
Records and signatures
- Audit trails enabled on GxP systems
- Electronic signature controls verified
- System validation records kept current
Continuity
- Contingency and disaster recovery plans exercised
- Backups restored and verified on schedule
- Incident response steps tested and recorded
Computerised systems that stay inspection ready.
Pharma and life sciences teams must show that GxP systems keep trustworthy records. Kmetog checks audit trails, validation status, signatures and backups on the systems inspectors care about.
- Audit trails. Confirmed enabled and unaltered on LIMS, QMS and ERP systems in scope.
- Validation. Records kept current, with changes routed through documented change control.
- Data integrity. Backup and restore verified so records remain available for their retention period.
- Audit trail enabled on GxP systems11.10(e)Queued
- System validation records current11.10(a)Queued
- Electronic signature controls11.200Queued
- Backup verification on LIMSAnnex 11 s7.2Queued
- Training records for system users11.10(i)Queued
- Change control documentedAnnex 11 s10Queued
What teams in your sector ask
Is Kmetog itself a validated GxP system?
Kmetog is a compliance operations tool that tests and evidences your GxP systems. If you intend to rely on its records in a GxP context, we will support your own risk assessment and validation approach.
Does Kmetog store patient data?
Checks are designed to read configuration and access metadata rather than clinical content. Where a check touches sensitive data, only the minimum needed for the result is retained. See the Security page for detail.
Walk into your next inspection with the records ready.
Show us your HIPAA or GxP scope and we will map the controls Kmetog can run and evidence for you.