Audits & Gap Assessments
Cause-based (for-cause) audits and investigations
When something has gone wrong — a serious deviation, a complaint trend, a recall or a data-integrity concern — you need an independent view of what happened and why. A cause-based audit looks beyond the immediate event to the systems that allowed it.
- Triggers Serious deviations, complaints, recalls, OOS trends, data-integrity concerns
- Typical inputs Event records, investigations, batch and laboratory data
- You receive Investigation audit report with root-cause and CAPA recommendations
Overview
About Cause-Based Audits
Internal investigations can struggle to see systemic causes, particularly when the people involved are also investigating. An external, focused audit provides objectivity and depth, and its findings carry weight with management, customers and regulators.
We review the event and its investigation, interview the people involved, trace the relevant records and assess whether the root cause and corrective actions are adequate — and whether other products or batches could be affected.
Use cases
When this service helps
Serious or repeated deviations
Find systemic causes behind recurring failures.
Complaints and recalls
Assess the root cause and the scope of impact.
Data-integrity concerns
Review electronic and paper records against ALCOA+ principles.
Supplier quality failures
Investigate a supplier after a significant quality event.
Scope
What the service covers
- Review of the event, investigation report and timeline
- Interviews with the people involved
- Tracing of batch, laboratory and electronic records
- Root-cause analysis review and alternative causes
- Impact assessment across products, batches and markets
- Evaluation of proposed CAPA and effectiveness checks
Who does what
Product disposition, recall and reporting decisions remain with your quality unit and authorised persons. Globaxa provides an independent assessment.
What does ALCOA+ mean?
Data should be Attributable, Legible, Contemporaneous, Original and Accurate — plus Complete, Consistent, Enduring and Available. These principles are used to evaluate data integrity in paper and electronic records.
Methodology
How we work
A defined sequence, agreed with you at the start, so you always know what happens next and what we need from you.
- Understand the eventRecords and the existing investigation are reviewed.
- Gather evidenceInterviews and record tracing on site or remotely.
- Test the root causeWe assess whether the identified cause explains the evidence.
- RecommendSystemic CAPA and effectiveness checks are proposed.
Deliverables
What you receive
Investigation audit report
Findings, root-cause assessment and impact evaluation.
CAPA recommendations
Systemic actions with suggested effectiveness checks.
Technical basis
Guidelines we work to
- ICH Q9(R1) and ICH Q10Quality risk management and CAPA within the pharmaceutical quality system.
- EU GMP Chapter 1 and 8Investigation of deviations, complaints and recalls.
- PIC/S PI 041-1 and MHRA GXP data integrity guidanceExpectations for data governance and integrity.
What we need from you
- Deviation, complaint or recall records and the investigation report
- Relevant batch records, laboratory data and audit trails
- Organisation chart and contact persons for interviews
Please share confidential information only after an NDA is in place — we are happy to sign one first.
Market and jurisdiction considerations
Regulators may ask how serious events were investigated, especially where products are exported. A documented independent review can support communication with authorities and customers.
FAQs
Cause-Based Audits: frequently asked questions
How quickly can you start?
For-cause audits are prioritised. We confirm availability and an achievable start date when you contact us.
Will the report be shared with regulators?
The report belongs to you. We can prepare a summary suitable for sharing with a customer or authority if needed.
Can you audit our supplier on our behalf?
Yes, with the supplier’s agreement. The audit is then planned around the specific event.
Talk to us about Cause-Based Audits
Share your product, target market and timeline. We will review your requirement and propose a defined scope.
- OfficeFlat no 8-9-3/23/1, Subhash Chandra Bose Colony, Dathunagar, Kanchanbagh, Hyderabad, Telangana 500058, India
Open in Google Maps - Phone+91 81219 33381
+91 99894 74590 - Emailbd@globaxa.in
- Office hoursMonday to Friday, 10:00–19:00 IST