Our Engineering Services for the life sciences industry sector provide Automation Managers with our specialist experience of working with GxP Computerised Systems. Our proven approaches mean all systems delivered by us will meet strict regulatory requirements, and through working with both you and your Validation Manager, we make it easier for you to get endorsement for all required purchases.

Common Problems

Lack of clarity that the system proposed for purchase should comply with specific industry regulations.

Difficulty getting purchases approved by Validation Managers.

Our Solutions

Our knowledge and experience provides real clarity around regulation, guaranteeing the delivery of compliant systems and solutions.

Our validation services knowledge and approaches allows us to work with both you and your Validation Manager, helping you to manage all aspects of the project effectively and helping you to get the right system in place first time.

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“We needed to ensure that our new software installation would be 21CFR part 11 compliant.”

Approach

OdysseyVC’s experienced CSV engineers worked seamlessly with our internal automation team to expertly deliver a system following the GAMP Lifecycle phases of Concept, Project and into Operations.

Result

Successful installation of new compliant system delivered ahead of schedule, on budget and in an Audit Ready state.

“OdysseyVC’s expert knowledge of the Computerised System Validation Lifecycle ensured we installed a 21CFR Part 11 compliant system, right first time.”

Generic Pharmaceutical Client

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