The Pharmaceutical Research & Development department had a validated SQL*LIMS v3.1.2 system in production. As a result of the discontinuation of vendor support for v3.1.2 and an internal regulatory assessment based on new corporate requirements, a migration of the existing SQL*LIMS system to v4.1 was required.
The main objective of the project was to implement a validated system that was 21 CFR Part 11 compliant and fully supported by the vendor, while adhering to newly defined corporate SOPs.
In meeting the business objective, the following project constraints were identified:
- Leverage the validation documentation from the original v3.1.2MR validation effort in 1999.
- Comply with current company SOPs.
- Adhere to the existing project schedule to remain synchronized with the implementation team.
The objectives and constraints were identified before starting the project, and a project plan was created to define the tasks and deliverables required to meet the business objectives.
The primary factors in selection of LabAnswer for this project were LabAnswer's knowledge and experience with SOPs; LabAnswer’s validation and informatics experience, especially with SQL*LIMS and other LIMS; and their ability to quickly build and manage a team of qualified resources. Other contributing factors were LabAnswer’s track record of successful informatics validation and implementation projects at this company, as well as being a preferred provider.
LabAnswer’s services were retained to manage and perform the validation activities of the project. The following tasks and deliverables were defined:
- Preparation of the Installation Qualification Protocols and IQ Test Cases
- Functional Gap Analysis of the existing OQ/PQ Test Cases
- Preparation of the Operational Qualification Protocol and OQ Test Cases
- Preparation of the Performance Qualification Protocol and PQ Test Cases
- Preparation of the Traceability Report
- Preparation of the Qualification Plan
- Management/Training of the OQ and PQ Test Execution
- Preparation of the Validation Summary Reports
Critical success factors identified during the planning stages of the project were:
- The implemented system must be 21 CFR Part 11 compliant and fully supported by the vendor
- Defined methods of communication and issue mitigation among the project team are established, utilized and enforced
- Resources are fully committed to the validation effort of this project
- Complete understanding of expectations, roles, and responsibilities between all parties is established.
Due to the constraints, this project was relatively complex and it was important that the system be validated by a specific date to meet corporate requirements. A major obstacle was presented when the requirements document was rewritten, resulting in the loss of traceability to the existing test cases. The update of the existing OQ test cases to meet these new requirements proved to be more time consuming than originally anticipated, so additional resources were added to the task. To maintain the required delivery time, a phased release approach for the OQ test cases was implemented. This assured that the client’s testing resources that had been assigned were kept on schedule. Multiple changes to the requirements during test case preparation also required very strong communication to assure that changes were addressed and traceability between requirements and tests was maintained.
The project schedule was maintained and the system was released into production earlier than planned. The ultimate success of the project was assured due to management commitment at the pharmaceutical, strong communication between the LabAnswer and the project teams, and a well-defined project team approach between functional departments and team members at LabAnswer. The communication and working environment was enhanced by a close, long-term relationship that allowed issues and changes in scope to be dealt with promptly and effectively.