Pharma and biotech companies on Qualio, from preclinical biotech to commercial manufacturing

THE BINDER GETS BUILT THE WEEK BEFORE

Preparing for the inspection takes longer than the inspection

An FDA investigator or an EU inspector sends the dates and a list of what they will read. Quality spends the days before pulling it all into one binder, and the inspector reads it in a morning.

Training sits in the LMS

Completions are exported and reconciled by hand.

Deviations sit in a tracker

Each one is chased to its CAPA before it goes in the binder.

Supplier audits sit in an inbox

The reports are found and filed the week before.

THE AUDIT PACK IS ALREADY BUILT

Qualio runs the processes and assesses every record against cGMP

Qualio runs the processes the inspector reads, the deviation, the change control and the supplier qualification, each routed to the people who sign it. It maps cGMP, GCP and ICH Q10 to those records and assesses each against its clause as it changes, with a recommendation on every gap. When the dates come, Qualio exports the audit pack by clause with the evidence behind each, so the weeks before an inspection are ordinary weeks.

The Results

200

Documents controlled in three months.

VitaCyte

80%

faster audit-readiness

Logixx Pharma

How it works

The shared drive, the training spreadsheet and the deviation tracker, retired

Qualio reads SharePoint and Confluence as they are, and ComplianceWire gets the approved procedure for training.

Quality Management

Qualio holds the procedures, training, deviations, CAPAs, change controls and supplier files the whole company works in, so the inspector reads the approved version of each.

Compliance Frameworks

Qualio maps cGMP, GCP, ICH Q7 and Q10 once and assesses every record clause by clause as it changes, so you find each gap before the inspector does.

Copilot

Drafts the deviation write-up, the change control, the SCAR and the training quiz from your own records. Every output cites its source and waits for your approval.

DEVIATIONS, OOS AND CAPA UNDER cGMP

Every deviation is traceable from the batch to the CAPA that closed it

Log the deviation or the OOS result against the batch, the procedure and the supplier it concerns
Open the investigation from the event, with the write-up drafted and waiting for the investigator's signature
Pull the trends by product, site and supplier when the annual product review is due

CAPA-034 for a cleanroom humidity excursion, from deviation DEV-112 opened from the batch record through root cause, corrective action and effectiveness check, with its audit trail

CHANGE CONTROL UNDER ICH Q10 AND PART 11

A process change retrains the people it affects before it takes effect

See the procedures, specifications and validation documents linked to a change before anyone approves it
Route it to the approvers your procedure names and sign it under Part 11
Make it effective on the date you set, and the retraining goes out that day to everyone who follows the procedure

Training impact of SOP-021 v3.0 becoming effective, with 18 training assignments created across QA, production and regulatory

SUPPLIERS, CDMOs AND CROs UNDER cGMP

Supplier quality sits beside the deviations it causes, CDMO included

Qualify each supplier once, set the audit schedule by its risk and keep the audit reports with its file
Link every deviation and complaint to the supplier behind it, and track that supplier's performance from those events
Raise the SCAR from the deviation, with the letter drafted and waiting for approval

Qualio supplier record with its risk level, supplier details, approvers and tabs for supporting documents, audits and tasks

CELL, GENE AND TISSUE UNDER 21 CFR PART 1271

Donor to dose, on the same procedures the inspector reads

Qualio maps 21 CFR Part 1271, the FDA's Current Good Tissue Practice for HCT/Ps, and the AATB standards beside cGMP, and assesses your procedures and records against every standard that applies.