Supplier Qualification Software

What Supplier Qualification Software Does, and Who Uses It

CORPEX-SQ is the supplier qualification module inside CORPEX-eQMS: a working record of every supplier your company is entitled to buy from, why they were approved, and what has happened since.

The people who live in this module are quality assurance staff, supplier quality engineers, and procurement leads at pharmaceutical, food and chemical manufacturers who cannot simply place a purchase order with a new raw-material supplier, packaging vendor or contract manufacturer. Each one has to be evaluated first, approved on record, and then watched over the life of the relationship. CORPEX-SQ is where that evaluation, approval and monitoring gets written down.

It replaces the spreadsheet-and-shared-drive version of a supplier file, the one where the last audit report is on someone's laptop and nobody is quite sure which certificate is current, with a single supplier record that holds contact details, certifications, risk classification, audit history and open non-conformances in one place.

The Regulatory Requirement: EU GMP Chapters 5 and 7, ICH Q10

Supplier qualification is not a procurement nicety. It is a written obligation in the frameworks most CORPEX customers are inspected against.

EU GMP Chapter 5 — Production

Chapter 5 requires that starting materials, particularly active substances, are purchased only from approved suppliers, and that the approval itself is based on an assessment of the supplier's ability to meet the required specification and quality standard consistently. That assessment, and the approval decision it leads to, is exactly what the supplier database and risk assessment fields in CORPEX-SQ are built to record.

EU GMP Chapter 7 — Outsourced Activities

Chapter 7 governs any activity a company hands to a third party: contract manufacturing, contract testing, or a specific processing step. It requires the Contract Giver to evaluate the competence and suitability of the Contract Acceptor before work begins, and to define the responsibilities of each party in a written agreement. In practice, that quality agreement sits alongside the supplier's other qualification records (the audit report, the certificates, the risk classification) wherever an organisation keeps its controlled supplier documentation, whether that is the CORPEX-SQ supplier file itself or a centralized document system such as CORPEX-DC.

ICH Q10 folds all of this into the pharmaceutical quality system itself. It places "management of outsourced activities and purchased materials" under management responsibility, meaning a company cannot treat supplier qualification as a one-time gate at onboarding. ICH Q10 expects ongoing monitoring of supplier and contract-acceptor performance, periodic reassessment of risk, and a feedback loop back into the quality system when a supplier's performance changes — which is the reason CORPEX-SQ treats a supplier record as something to keep updating, not a form to fill in once.

How the CORPEX-SQ Workflow Runs, Step by Step

Six linked stages carry a supplier from first evaluation to ongoing performance monitoring.

1. Supplier Database & Approved Supplier List

Every supplier gets one record: contact information, certifications, performance history and a risk assessment. Together these records form the organisation's approved supplier list — the one document every EDA or ISO 9001 audit asks to see first.

2. Audit Planning

Audits are scheduled by risk assessment and contractual requirement rather than a fixed annual calendar, so a critical API supplier gets audited more often than a low-risk packaging vendor.

3. Audit Execution

The audit itself runs on customizable checklists and forms, with evidence and findings captured in real time rather than written up from memory once the auditor is back at their desk.

4. Non-Conformance & SCAR Tracking

A finding from the audit becomes a tracked non-conformance, routed to the supplier as a Supplier Corrective Action Request (SCAR) and followed through to closure rather than left as a line in a report nobody reopens.

5. Reporting & Analytics

Reports and dashboards turn individual supplier records into a picture of the whole vendor base — which suppliers are trending toward more findings, and which ones are due for reassessment.

6. Risk Management

Risk assessment runs alongside the rest of the record, so a supplier flagged for financial instability, a quality trend, or a history of disruption is visible before it becomes a stock-out or a batch problem.

What Auditors and Inspectors Look For in a Supplier File

An EDA GMP inspection or an ISO 9001 surveillance audit tends to check the same handful of things in a supplier record. Here is how CORPEX-SQ answers each one.

Is the approved supplier list current?

The supplier database is the list. There is no separate spreadsheet to reconcile against it, so what an auditor pulls up is what procurement is actually buying against.

Is there qualification evidence for every critical supplier?

Certifications, risk assessments and audit history sit on the same record, so a reviewer can trace a single API supplier from initial evaluation through the most recent audit without requesting a second file.

Were findings closed, not just logged?

Non-conformances tracked through to SCAR closure show the difference between a supplier that had one bad audit and one that has a habit of not fixing what it is told.

Is monitoring ongoing, or only at onboarding?

Reporting and analytics give a running view of supplier performance, which is the evidence ICH Q10's expectation of continued monitoring is asking for.

How Supplier Qualification Connects to the Rest of CORPEX-eQMS

A supplier record rarely stays inside CORPEX-SQ on its own. It is the starting point for three other parts of the quality system.

Audits

Supplier audits are planned, scheduled and executed through CORPEX-AM audit management, which shares the same document control backbone used to store audit evidence.

CAPA

A SCAR the supplier does not close, or a repeat non-conformance, is escalated into the organisation's own corrective and preventive action process through CORPEX-CAPA.

Change Control

A supplier change, such as a new manufacturing site, a formulation or component change, or a new sub-supplier, is assessed and approved through CORPEX-CC change control before it is accepted into the qualified supply chain.

A defect a customer notices before your own quality team does often surfaces first in CORPEX-CM complaints management, which is the other direction a supplier issue can enter the system.

Implementation and Validation

CORPEX-SQ is deployed and validated as part of the wider CORPEX-eQMS rollout: existing supplier records are migrated under control, risk categories and audit intervals are configured to match your procedures, and the module is qualified alongside the rest of the platform. See computer system validation (CSV) services for how CORPEX documents IQ, OQ and PQ for a module like this one, and produces the traceability an EDA or EGAC inspection expects to review.

Supplier Qualification Software in Egypt

Egyptian pharmaceutical manufacturers qualify their raw-material and packaging suppliers under Egyptian Drug Authority (EDA) GMP inspection, which increasingly checks that the approved supplier list, audit evidence and SCAR closure are controlled records rather than a folder on a shared drive. A laboratory qualifying a contract-testing supplier looks for EGAC ISO/IEC 17025 accreditation as part of that same evaluation.

CORPEX-SQ is delivered as part of CORPEX-eQMS in Egypt, with Arabic and English support and an implementation team based in the New Administrative Capital, so supplier quality staff and EDA auditors both work with the record in the language they use day to day.

Supplier Qualification Software — Frequently Asked Questions

What is supplier qualification software?

Supplier qualification software is the system a quality or procurement team uses to evaluate a vendor before use, keep the approved supplier list current, plan and record supplier audits, track non-conformances raised against a supplier, and hold the evidence an inspector expects to see for every critical supplier. CORPEX-SQ is the supplier qualification module of CORPEX-eQMS.

Does CORPEX-SQ maintain an approved supplier list?

Yes. The supplier database in CORPEX-SQ holds contact information, certifications, performance history and risk assessments for each vendor, which functions as the organisation's approved supplier list and the starting point for audit planning and reporting.

How does CORPEX-SQ schedule and run supplier audits?

Audits are scheduled based on risk assessment and contractual requirements, then executed with customizable checklists and forms that capture evidence and document findings in real time. Any non-conformance identified during the audit is tracked through to a supplier corrective action request (SCAR).

What is the regulatory basis for supplier qualification in GMP?

EU GMP Chapter 5 requires starting materials to be sourced only from approved suppliers, EU GMP Chapter 7 requires a Contract Giver to assess the competence of a Contract Acceptor before outsourcing an activity, and ICH Q10 places management of outsourced activities and purchased materials inside the pharmaceutical quality system, with ongoing monitoring of supplier performance.

How does supplier qualification connect to CAPA and change control?

A SCAR that a supplier fails to close, or a pattern of recurring non-conformances, is escalated into the organisation's own CAPA process in CORPEX-CAPA. A change at the supplier, such as a new manufacturing site, a formulation change, or a new sub-supplier, is assessed through CORPEX-CC change control before it is accepted.

Is CORPEX-SQ used by pharmaceutical companies in Egypt?

Yes. CORPEX-SQ is part of CORPEX-eQMS, used by Egyptian pharmaceutical manufacturers, and is built around the supplier-qualification expectations an Egyptian Drug Authority (EDA) GMP inspection looks for, with Arabic-language support. See CORPEX-eQMS in Egypt.