Bundle - Software Quality Assurance SOPs

Package – Software Quality Assurance SOPs

$690.00

SOP Computer System Validation

Addresses the requirements for computer systems validation and includes sections on validation deliverables, roles and responsibilities, and quality assurance controls.

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.

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.

SOP System Risk Assessment

Assess and analyze the quality risk for systems used in regulated activities. Includes risk assessment timing, procedures, criticality, classification, and documentation.

SOP System Risk Management

Overall program of procedures and controls for managing quality risks for systems used in regulated activities.  Includes definitions, responsibilities, and approach.

SOP System Risk-Based Validation

Procedure for defining a validation approach based on the risk assessment and vendor audit. Includes details on the impact to validation testing and documentation.

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.

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.

SOP Change Control

Defines the controls for managing changes to regulated systems. Includes change request, impact assessment, authorization, cancellation, retention, and emergencies.

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.

SOP Incident Management

Defines the procedures for managing incidents regarding systems used in regulated activities. Includes incident reporting, investigation, resolution, periodic review, etc.

SOP Software Vendor Assessment

Outlines the quality assurance approach to audits and assessments of software suppliers. SOP is intended to be used with the Software Vendor Assessment template.

SOP System Security

Defines the controls needed to secure the systems, records, and data used in regulated business. Includes physical security, configuration protection, passwords, and more.

SOP System Backup

Defines the controls needed to back up the software and data for use in system restoration or recovery. Includes backup schedules, content, review, and verification.

SOP User Training

Defines the procedures and controls to ensure that employees have the training needed to perform assigned responsibilities regarding systems used in regulated activities.

SOP System Restore

This SOP defines the procedures and controls needed to recover the Information Technology infrastructure in the event of a system failure or disaster.

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.

This package of 17 software quality assurance SOPs is available for $690.  This is a 45% savings over individual purchases of the same documents!  You get:

  1. SOP Computer System Validation
  2. SOP SDLC – Custom Development
  3. SOP SDLC – Package Software
  4. SOP Risk Assessment
  5. SOP Risk Management
  6. SOP Risk Based Validation
  7. SOP Periodic Validation Review
  8. SOP Audit Trails
  9. SOP Alternate Records
  10. SOP Change Control
  11. SOP Document Management
  12. SOP Incident Management
  13. SOP Software Vendor Assessment
  14. SOP System Security
  15. SOP User Training
  16. SOP System Backup
  17. SOP System Restore