Investigations, CAPA and backlog remediation
An investigation is the written, evidence-based account of what went wrong, why, what it affected and what will stop it recurring. QLogixCMC investigates deviations, out-of-specification results and complaints with your team, concludes root causes the evidence supports, writes CAPAs that can be checked for effectiveness, and clears aged backlogs to the same standard.
What we do
- Deviation investigations: problem statement, scope, impact, root cause and CAPA
- OOS and OOT investigations to the FDA guidance: laboratory phase, then full-scale
- Complaint investigations and reportability assessments
- Root cause analysis: IS / IS NOT, fishbone, 5-Whys, fault tree and hypothesis testing
- CAPA plans with owners, timing and defined effectiveness checks
- Backlog remediation: triage by risk, standard work, and a weekly burn-down to closure
- Investigator training and coaching on live records
How the work runs
Every investigation starts with a problem statement in IS / IS NOT form, from the initial report and the records around it: the batch record pages, the lab data, the equipment history, the procedure in force and the earlier events that look alike. Root cause candidates are tested against that evidence, and the conclusion names the evidence that supports it and the candidates that were ruled out.
For a backlog, we triage every open record by product impact and age, agree a standard for what a closed record looks like, and work the queue in risk order with a weekly burn-down your quality unit can see. The goal is a backlog that stays closed, so recurring causes get one CAPA, not twenty.
What makes it hold up in an inspection
21 CFR 211.192 requires unexplained discrepancies to be thoroughly investigated, with the conclusions and follow-up recorded. An inspector reads the investigation for the evidence, the reasoning and the timeliness.
- Scope and impact assessed on every batch, product and system the event could have touched
- Root cause stated with the evidence, not as "human error" by default
- CAPA tied to the root cause, with an effectiveness check that can fail
- Timeliness: investigations completed within the procedure's limit, or the extension justified
- Trending across investigations, so a recurrence is seen before the next batch
Questions about investigations, CAPA and backlog remediation
How quickly can you take on a backlog?
QLogixCMC can start a backlog remediation within two weeks of the first call: the first week is triage of every open record by risk and age, the second sets the standard work and the burn-down. Records are closed in risk order, and your quality unit sees the queue every week.
Do you write the investigations or coach our people?
Both, and the mix is agreed at the start. QLogixCMC investigators write investigations with your team on live records and coach them as they go, so the site's own capability improves while the backlog comes down.
Can AI help with investigations?
Yes, in a decision-support role. Where a site's systems can draft the problem statement, list similar past events and propose root cause candidates from the records, quoting the evidence, QLogixCMC uses that output as a draft, and the investigator and the quality unit still review, edit, conclude and sign.
What counts as a defensible root cause?
One that the evidence supports, that explains the event as it happened, that rules out the alternatives considered, and that leads to a CAPA whose effectiveness can be checked. "Human error" is a symptom until the investigation shows why the error was possible.
Related services
- CMC and regulatoryChemistry, manufacturing and controls strategy and documentation, from the first IND through NDA or BLA approval, commercial supply and post-approval change, for small molecules, biologics, mRNA, cell immunotherapies and gene therapies.
- Quality systems and QMSA pharmaceutical quality system designed for how your site actually runs: gap assessment, procedures, remediation, and the move from paper or a legacy QMS to a validated electronic one.
- Validation and computer software assuranceRisk-based validation of computerized systems, equipment and processes, following GAMP 5 (Second Edition) and FDA's computer software assurance guidance, documented for inspection.
- Inspection readiness and compliance remediationFDA and EU GMP inspection readiness, mock inspections, internal and supplier audits, responses to FDA Form 483 observations and warning letters, and compliance remediation programs managed to closure.
- GxP systems implementation and administrationEngineers who implement the eQMS, LIMS, MES or document management system you have chosen, configure it to your SOPs, migrate and validate it, and then administer it for you day to day.
- AI and digital qualityAI in the quality system done in a way an inspector can follow: use cases chosen by risk, governance and validation in place, and agentic workflows that draft while your people decide.