The follow on to the vendor audit check list, whether it pertains to in-house or out-house audits is the Gap Analysis. This quantifies the the scope of work involved in attaining regulatory compliant status. As a consultant, the most often asked for service as soon as you arrived in a clients office is, a gap analysis. It is what everyone wants, a searching look into at all aspects of your current systems, to determine compliance and adequacy of current procedures. A gap analysis involves comparing regulatory requirements against current procedures and facilities in your facility. Differences are referred to as "gaps." It gives tremendous reassurance that the ship is water tight and under command.
The Gap Analysis tool allows you to systematically challenge the company’s cGMP policies and procedures, comparing them with the regulatory expected standards and allowing you to draw up a list all delinquencies. Until you can highlight the company’s deficiencies, you are not able to scope the task of becoming compliant. This is where the Vendor Audit Check List makes It possible for you to know what resources are required for the task.
| A. | Vendor Audit Check List from Validation-Online Company Overview | Done | Notes |
| A.1 | Audit details (address, audit team, supplier representatives) |
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| A.2 | Company size, structure and summary of history (number of sites, staff, organizational charts, company history) |
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| A.3 | Product/service history (main markets, how many sold, use in healthcare sector) |
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| A.4 | Summary of product/service under audit (product literature) |
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| A.5 | Product/service development plans |
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| A.6 | Tour of facility (to verify housekeeping, general working environment, working conditions) |
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| B. | Vendor Audit Check List from Validation-Online Organization and Quality Management |
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| B.1 | Management structure (roles, responsibilities) |
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| B.2 | Method of assuring quality in product/service (quality system, responsibilities for quality) |
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| B.3 | Use of a documented Quality Management System (QMS) e.g., existence of a quality policy and objectives, quality manual, process definitions/procedures, standards |
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| B.4 | Maturity of QMS (relevance to product/service under audit) |
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| B.5 | Control of QMS documentation (reviews, approvals, distribution, updates) |
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| B.6 | Maintenance of QMS documentation (regularly reviewed and updated when appropriate) |
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| B.7 | QMS certified to a recognized standard (e.g., ISO9001) |
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| B.8 | Method of checking compliance with QMS (internal audits, management reviews) |
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| B.9 | Qualification and suitability of staff |
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| B.10 | Independence of auditors, inspectors, testers, reviewers |
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| B.11 | Staff training (general, QMS, product/service related, new staff, changes to QMS, regulatory issues, training records) |
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| B.12 | Use of sub-contractors (individuals, companies): |
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| Method of selection |
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| Sub-contractor qualifications and training records |
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| Specification of technical and quality requirements in orders placed |
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| Method of accepting product delivered by sub-contractor |
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| B.13 | Experience of validation process (with other customers, previous Supplier Audits, services provided by supplier, involvement in regulatory inspections) |
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| B.14 | Awareness of healthcare regulatory requirements (knowledge of regulations, subscription to publications, attendance of relevant events, involvement in industry groups) |
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| B.15 | Continuous improvement programme (use of metrics to evaluate and improve effectiveness of QMS) |
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| C. | Vendor Audit Check List from Validation-Online Planning and Product/Project Management |
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| C.1 | Use of quality and project plans (per project/product, defining activities, process definitions/procedures, responsibilities, timescales) |
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| C.2 | Status of planning documentation (reviews, approvals, distribution, maintenance, and update) |
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| C.3 | Documentation of user/supplier responsibilities |
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| C.4 | Use of Validation Plan where supplied by user company |
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| C.5 | Project management and monitoring (mechanism, tools, progress reports) |
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| C.6 | Accuracy of, and conformance to, planning and management process definitions/procedures |
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| C.7 | Use of formal development life cycle |
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| C.8 | Evidence of formal contract reviews where applicable |
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| D. | Vendor Audit Check List from Validation-Online Specifications |
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| D.1 | User Requirements Specifications |
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| D.2 | Functional Specifications |
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| D.3 | Software Design Specifications |
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| D.4 | Hardware Design Specifications |
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| D.5 | Relationship between specifications (together forming a complete specification of the system which can be tested objectively) |
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| D.6 |
