A contract pharmaceutical testing lab had received citations from Health Canada regarding the data integrity of their Waters Empower™ 2 CDS. The client had individual Empower 2 workstations operating with limited control over roles and their system access. They had tried to initiate short-term solutions for the data integrity issues, but they learned that their solutions may become unmanageable as the data grows in volume – creating more problems down the road. Health Canada gave them 90 days to resolve their noncompliance.
CSols Inc. was selected to assess the Waters Empower™ CDS workstations due to our extensive experience with Empower CDS and the success we’ve had with other similar projects. The client recognized CSols as a leader in the laboratory informatics space with proven best practices.
Objectives and Challenges
The objective of this project was to get the client’s Empower 2 systems in compliance with Health Canada so their laboratory testing could continue. There were many shortcomings that needed to be identified and then paired with a solution. Unfortunately, the client did not have the Empower 2 expertise to address these issues.
CSols’s Role in the Solution
The CSols Empower CDS expert began with Lab Systems Audit to evaluate all the gaps in the Empower 2 systems that were flagged by Health Canada. During the evaluation, an upgrade to Empower 3 was recommended to help the client become more sustainable and scalable moving forward. The following are the key tasks and deliverables.
- Evaluation of the current footprint – Performed a deep dive to determine the best areas for improvement that follow overall compliance and best practices. Used the current regulatory situation to help determine an action plan.
- Proposed short-term solutions – Developed a plan to address the regulatory compliance gaps cited by Health Canada. This plan addresses data integrity by placing additional controls where needed, segmenting roles and responsibilities on the system, and locking down functions as appropriate.
- Short-term report – Documented all solutions in a final report to share with regulatory bodies so that they can overturn their citations.
- Proposed longer-term solutions – Developed a strategy for upgrading their system from Empower 2 to Empower 3 FR5 so they would become more compliant and efficient, and remove paper processes where possible.
- Long-term report – Documented the long-term solution in a report that detailed how to change business processes, upgrade the system, use recommended best practices, and train the staff.
The expertise provided by the CSols Empower consultant delivered the following benefits for the client:
- The client received a roadmap report, identifying all gaps found in their Empower 2 CDS along with recommended steps to address the Health Canada citations and ensure their data integrity.
- Once the roadmap is implemented, the data integrity issues will be remedied, thereby lifting the citations and allowing work to resume.
- An upgrade path was detailed in the roadmap to assure the client of compliance, and remove the worry of receiving future citations.
Without the CSols consultant’s thorough knowledge of Empower CDS, the client may not have been able to address the issues identified by Health Canada in a comprehensive way that also provided a path to future upgrades.
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