System Validation as a service
AgosIT offers custom risk-based validation for systems. This includes all the required Validation Lifecycle documentation;
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.
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 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.
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.
Managed and professional services to develop and evolve your organization’s requirements.
Supporting and aligning your business goals with technical solutions and regulatory compliance.
Tailored, tested compliant industry software (SaaS) for operational and scientific use.
Ensuring compliance and inspection readiness by engaging people and systems through quality control, guidance and configuration management.