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Computer System Audit Services - Are You US FDA/EU audit ready?
Audit Areas

Regulatory authorities globally are looking more into your computerised systems and wanting to see what validation work has been performed and documented. You need to ensure that all your systems are secured, validated, properly maintained and ready to withstand inspection from regulatory agencies, such as the FDA, and prospective customers.

We conduct CSV audits of the software, IT infrastructure, and IT services your company relies on, whether on your premises or off-site at a vendor facility. We verify compliance with 21 CFR Part 11, EU Annexure 11, and Good Automated Manufacturing Practice (GAMP 5) as appropriate. We also assess other quality system elements and supporting processes including staff training, SOPs, document control, corrective and preventative actions, and change management

We perform several different kinds of CSV audits, all of which can be integrated with any amount of GxP compliance auditing.

  • Pre Audits or System Readiness Audits to ensure that your systems and documentation are upto date and under compliance before any major FDA or EU audit.

  • Follow-Up Audits to ensure that the level of quality, service, and support verified during a previous audit is being maintained, particularly if there has been a major change or significant upgrade to a product.

  • Vendor Audit to ensure that quality and reliability of supplier to provide and support computer system for pharmaceutical regulatory framework.

CSV Audits Areas:
  • Review the validation status of your computer systems

  • Review the validation documentation for internal and vendor provided documentation

  • 21 CFR Part 11 compliance

  • Identify gaps in the validation status

  • Advice on how best to bring your systems into compliance

Vendor Audits:
  • Verification of the quality management system

  • Verification of 21 CFR Part 11 compliance

  • Verification of lifecyle support

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