Comeply Quality System
The quality system that understands the regulations.
A full electronic quality management system (eQMS) for life sciences, live in production. Twelve registers in one platform, with the regulatory landscape Comeply already monitors built in.
The registers
Twelve registers in four groups.
One system instead of separate tools for documents, training, events, CAPA, change, audits, risk and suppliers. And we keep adding.
Documents and training
Controlled documents
Procedures under change control: authored, approved, released and reviewed on a cadence.
Curricula and training
What each job function must read and be trained on.
Events and change
Quality events
Deviations and nonconformances: what happened, why, and what was done.
CAPAs
The root cause, the plan that addresses it, and proof over time that the cause is gone.
Change requests
Planned changes: the impact assessment, the approvals and the verification.
Complaints
Feedback from the field, its reportability clocks, and the investigation.
Assurance
Audits
Internal audits: the programme, the checklist, the findings and their closure.
Risk files
Hazards, their estimated risk, the controls, and what is left after them.
Management reviews
Where the quality system is read as a whole and top management decides.
Suppliers and equipment
Suppliers
Who you buy from and the basis on which they are approved.
Supplier corrective actions
Problems put to a supplier, and the answers they came back with.
Equipment
Instruments and systems, their calibration, maintenance and qualification.
Built in
Controlled by design, and connected to the regulations.
Electronic signatures, bound to the record
Approvals, releases and closures are signed electronically, and each signature is bound to the record it was executed against.
Guided setup, not a blank page
Modules switch on one at a time. Numbering, review intervals, retention periods and time zone start from sensible defaults that you confirm, and you define your sites, areas, processes and products so every record is filed where it happened.
Connected to the intelligence layer
A regulatory change can be traced to the documents it affects, the change request that follows, the training it calls for and the CAPA that closes it.
Keeping your current QMS?
Compliance Intelligence
The regulatory layer on its own, on top of Veeva Vault, MasterControl or a similar system.
See Compliance Intelligence →Putting your first QMS in place?
Starting out
How the quality system works for a startup, and how it grows with you.
See the startup path →Let's talk
