Package – Software Quality Assurance SOPs

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

This SOP establishes the development life-cycle that is used to guide design, development, maintenance, and retirement of custom developed software systems.

Establishes the development life-cycle that is used to guide design, procurement, configuration, maintenance, and retirement of commercial off-the-self (COTS) systems.

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

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

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

Defines the procedures and controls necessary for the audit trails within systems used in regulated activities. Includes audit trail archival, periodic review, etc.

Defines the procedures for continuity of operations for regulated business functions using computerized systems in the case of computer system failure or unavailability.

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

Procedures and controls for managing the SOPs for systems used in regulated activities. Includes SOP preparation, approval, periodic review, access, retention, and training.

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

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

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

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.

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

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

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.