--- title: "Pharma & Biotech Quality Management Software | Qualio" canonical: "https://www.qualio.com/solutions/biopharma" updatedDate: "2026-11-03T16:27:27.000Z" description: "Qualio runs deviations, CAPAs, change control and supplier quality for pharma and biotech companies, and assesses every record against cGMP, GCP and ICH Q10." --- # Pharma & Biotech Quality Management Software | Qualio Qualio runs deviations, CAPAs, change control and supplier quality for pharma and biotech companies, and assesses every record against cGMP, GCP and ICH Q10. ## From preclinical to commercial supply Procedures, training, deviations and CAPAs. Change control and suppliers. Assessed against the standard each phase brings. ## 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. ## 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. Documents controlled in three months Faster audit-readiness ## 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. ## 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 ## 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 ## 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 ## 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. ### Donor eligibility Screening and testing procedures and records, assessed against Part 1271. ### Manufacturing controls Processing, storage and distribution procedures, assessed against Current Good Tissue Practice. ### Adverse event reporting Each report logged as a quality event, with its investigation and CAPA linked. ### ICH ### GCP ## What pharma and biotech companies say ## More for pharma and biotech teams ### From Lab to Launch ## Less time on paperwork. More time on the science.