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 Acennix helps organisations build
sound strategies and streamline operations, for solid, reliable results. Our validation solutions help companies meet regulatory requirements, including satisfying inspections, achieving product approvals and complying with regulations.
Acennix’s consultants have extensive validation experience in the pharmaceutical and biomedical sciences industry. We are familiar with FDA, EU and TGA requirements. Our proprietary methodologies adhere to current regulations and best practices and can be integrated into companies’ existing systems.
Acennix specialises in:
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Developing Validation Master Plans
(VMP), Validation plans and protocols; |
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Handling Re-validation and Re-qualification; |
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Qualifying utilities, facilities and equipment; |
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Putting in place documentation systems, policies and procedures; |
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Conducting specific validation tasks, such as Cleaning, Analytical method and Computer System Validation; |
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Carrying out Site Acceptance Tests (SATs) and Factory Acceptance Tests
(FATs); |
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