LABORATORY INFORMATICS

The validation project was completed on time and approximately 24% under budget on a fixed-price bid.

 

TotalChrom Disaster Recovery Validation Effort

Business and Technology Goals

In order to meet regulatory and corporate requirements, the company needed to implement and validate an environment to be used for Disaster Recovery for their existing production TotalChrom v6.2 system. Since the Disaster Recovery environment would be virtually identical to the production environment, the project would leverage the validation documentation from the production system validation in 2002, updating it where necessary to meet current SOPs.

Solution

The primary factors in selection of LabAnswer for this project was LabAnswer’s knowledge and experience with this company's SOPs; LabAnswer’s validation and informatics experience, especially with TotalChrom and other Chromatography Data Systems; and their ability to quickly build and manage a team of qualified resources.

Due to being involved in several different projects for this client, across multiple divisions, spanning from LIMS to CDS systems, LabAnswer had become familiar with corporate level procedures and policies and was able to leverage this during validation of a Total Chrom Disaster Recovery System. 

Using a risk-based approach, LabAnswer reviewed the current production system qualification deliverables to identify documentation that could be leveraged during the disaster recovery system effort. 

LabAnswer was also responsible for providing quality and technical reviews of the disaster recovery system validation documentation, offering support in meeting regulatory requirements and ensuring traceability.  In addition to quality and project management support, LabAnswer also provided a team of testers to manage and execute the disaster recovery system qualification test cases, while meeting a rigorous timeline. 

Benefits

  • A fully implemented and validated disaster recovery environment for production that meets regulatory and corporate requirements and ensures traceability.
  • Production validation documentation was leveraged to achieve quicker turnaround.
  • LabAnswer project team experience with company systems allowed for on-time/under budget project completion, meeting the clients rigorous timeline.