In support of its internal effort to improve productivity in the research and development (R&D) and Quality laboratories, Zosano, a clinical-stage biopharmaceutical company, planned to transition away from paper record-keeping and implement a laboratory information management system (LIMS) from the LIMS software provider, Quality System International Corporation (QSI).
The vendor completed the implementation successfully; however, the vendor did not have sufficient resources to complete the validation activities required of software to be used in a GxP environment. Zosano also faced internal resource constraints.
QSI knew CSols as a company that could complete the testing documentation effectively and efficiently and introduced CSols to the client. As a result, CSols was ultimately chosen, as a premier LIMS consultancy with expertise in LIMS validation to achieve the defined validation objectives for the new WinLIMS implementation.
Objectives and Challenges
Zosano was experiencing a significant loss of time and efficiency by using a paper process in their laboratory. They would continue to accumulate an unmanageable amount of paper records, which had been inefficient and was preventing growth if they continued on their current path. The tracking, traceability, and audit trail maintenance for the data would continue to be difficult for quality management.
The goal of this project was to validate the QSI LIMS product, WinLIMS, by creating standard validation deliverables per Zosano’s guidelines. In addition, the client was also interested in developing all the supporting Standard Operation System (SOPs) required for the LIMS.
There were a few hurdles to overcome to achieve these objectives:
- Neither Zosano nor QSI had sufficient experience in computer system validation. Therefore, Zosano hired CSols to provide validation oversight and create the required validation deliverables.
- Zosano also needed some additional project leadership assistance to help keep the project moving forward. CSols provided that leadership to accomplish the validation tasks in the time allocated in the SOW.
- Zosano did not have existing software validation procedures. CSols provided the guidance and associated templates to use for all deliverables and tasks, following a risk-based approach.
CSols’s Role in the Solution
After QSI completed their implementation of WinLIMS, CSols joined the project to perform computer system validation services. CSols followed GAMP5 guidelines for configurable systems and practiced a risk-based approach for software validation. The first step was to request Functional Requirements Specifications, IQ, and OQ documentation from QSI to identify gaps. Then, CSols developed the following standard CSV deliverables to support the validation effort.
- Validation Plan
- User Requirements Specification
- Functional Risk Assessment
- OQ and PQ Protocols
By bringing in CSols to complete the computer software validation, Zosano received the following benefits:
- Expert validation project leadership that helped the client understand the validation process and ensure a complete set of documentation that Zosano can defend
- An on-time project completion that allowed Zosano’s staff to continue their day-to-day jobs
- Validation documentation that can be re-used for future changes to the system, allowing for quicker turn-around times and less re-work
- A trusted partner that knows their system
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