CSV Services

Computer System Validation (CSV)

System Validation as a service

AgosIT offers custom risk-based validation for systems. This includes all the required Validation Lifecycle documentation;

  • Validation Plan
  • User Requirement Specification
  • Risk Assessment
  • Design Qualification and Review
  • Test Plan
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Test Report
  • Requirements Traceability Matrix
  • Validation Report

AgosIT also offers Periodic Lifecycle Reviews for existing or new systems to ensure compliance is maintained for the system lifecycle. AgosIT can manage the end of life and decommissioning process.

Audit Inspection Readiness

Pre-Audit Inspection

AgosIT Pre-Audit Inspection services can be performed as full disclosure audits used to identify compliance risks before they are found by a regulatory body. Alternatively, they can be used as closed mock audits to encourage audit readiness which allow staff the opportunity to train without the risk of regulatory findings.

Control Room Setup & Management

A good control room process is key to a successful audit, AgosIT can identify process improvements and support control room management for regulatory audits.

Following a regulatory audit, it is important to respond to any findings. AgosIT can assist with identifying Corrective and Preventative Actions to ensure the finding is mitigated.

Data Integrity Assessments

Data Status Identification

AgosIT can assess the data integrity compliance of electronic systems and computerised laboratory equipment to identify the raw, primary and metadata.

Once the key aspects of data are identified, AgosIT can provide Managed Backup Solutions through Technical Services and ensure data is properly stored, protected and restorable.

SOPs and Policies

Documentation Creation and writing support

AgosIT can assist with writing GxP critical procedures and processes such as; Validation Master Plan, Access Management, Change and Incident Management.

Reviewing existing procedures for operational and regulatory compliance. AgosIT Documentation Services ensure regulatory compliance and reduced errors in operations by getting the documented process and procedures are clear and up to date.

Training and Vendor Selection

Training

  • GxP Documentation Training – On premise or hosted training in best practices for completing GxP documentation.
  • System and Process Training – Risk Assessment, Change Management, Deviation Assessment and CAPA.

Vendor Selection

  • Supplier audits and assessment, supplier recommendations and support.

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