Document Library
Showing 97–112 of 179 results
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CSV Template – Validation Incident Report (v 2)
This Validation Incident Report template is used to document the occurrence and resolution of incidents encountered during software validation testing. Basic version.
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CSV Template – Validation Master Plan
The Validation Master Plan (VMP) describes the organization’s overall strategy, approach, and responsibilities for validation of computer systems and software.
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CSV Template – Validation Plan
The Validation Plan describes the validation deliverables, testing approach, and schedule. It also defines responsibilities for creating and approving each validation deliverable.
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CSV Template – Validation Protocol – OQ or PQ
The OQ/PQ Validation Protocol is used to document the system’s ability to meet the functional requirements specifications (OQ) and user requirements specifications (PQ).
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CSV Template – Validation Summary Report
The Validation Report documents the validation approach and conclusion that the system is certified for operational use based on the validation testing results.
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EMA Annex 11 Computerised Systems FAQ Q&A, 2/11
The EMA published answers to frequently asked Annex 11 questions. The EC’s new version of Annex 11, Computerised Systems, went into effect on June 30, 2011.ﾠ
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CSV Template – Vendor Assessment
The Vendor Assessment is used by auditors to evaluate a software supplier. Template includes over 250 specific vendor assessment questions from 83 inspection categories.
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SOP Alternate Records
Defines the procedures for continuity of operations for regulated business functions using computerized systems in the case of computer system failure or unavailability.
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SOP Audit Trails
Defines the procedures and controls necessary for the audit trails within systems used in regulated activities. Includes audit trail archival, periodic review, etc.
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SOP Change Control
Defines the controls for managing changes to regulated systems. Includes change request, impact assessment, authorization, cancellation, retention, and emergencies.
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SOP Computer System Validation
Addresses the requirements for computer systems validation and includes sections on validation deliverables, roles and responsibilities, and quality assurance controls.
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SOP Document Management
Procedures and controls for managing the SOPs for systems used in regulated activities. Includes SOP preparation, approval, periodic review, access, retention, and training.
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SOP Incident Management
Defines the procedures for managing incidents regarding systems used in regulated activities. Includes incident reporting, investigation, resolution, periodic review, etc.
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SOP Periodic Validation Review
The Periodic Validation Review SOP defines the steps and process for periodic review of validated systems to ensure that each system remains in a validated state.
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SOP SDLC for Custom Development
This SOP establishes the development life-cycle that is used to guide design, development, maintenance, and retirement of custom developed software systems.
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SOP SDLC for Package Software
Establishes the development life-cycle that is used to guide design, procurement, configuration, maintenance, and retirement of commercial off-the-self (COTS) systems.
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