Wouldn’t it be nice to be able to skip over the time, complexity and cost of validating your LIMS? A software vendor has brought a commercial off-the-shelf software package to market that is prevalidated and is able to provide significantly lower total cost of ownership.
For highly regulated environments such as the pharmaceutical industry, purchasing a piece of software is only the first step in a long process toward use in a production environment. Validation involves several stages, starting with an outline of user requirements and a function and design specification, through to a review of the installation, an operational test of the system and finally a performance evaluation.
The validation plan will also include other items such as acceptance criteria, change control, risk management and a plan for handling deviations. The company also needs to take into account existing project and system SOPs, the team’s computer system training and end-user training. Only when all these factors have been dealt with can the validation execution begin.
Shortlist for success
The final responsibility for validation compliance lies with a drug or medical device manufacturer, rather than the software vendor. The latter can provide the scripts and documentation to assist the customer in their validation effort. However, this still requires extensive planning and execution by the customer to reach a fully validated state. In the case of SQL*LIMS® P4™, the vendor can provide the main set of deliverables the customer would need to eliminate most of the validation work and go live with a pre-validated system.
It includes:
- Project management. Overall management of the entire effort as a project. Utilise appropriate planning and budgeting techniques, encase the project with the appropriate project SOPs, understand and manage the risks as well as utilise proper change control procedures.
- Computer systems validation (CSV) training. Ensure and document that all team members involved in the development and validation effort have attended a CSV course. Ensure this documentation is part of the validation package provided to you.
- Requirements. Utilise industry best practices to create and complete a requirements document that is clear, concise and testable.
- Design and configuration. Utilise industry best practices to design and configure the system that meets most of your needs.
- End-user SOPs, workflows and lifecycle documentation. Create standardised SOPs and workflows utilising industry best practices. Also, ensure appropriate lifecycle documents exist. For instance, finished goods manufacturing, stability and laboratory sample life cycles are provided for PQ testing.
- Development. Any development such as building generic or standard reports identified in the design stage should be created in a fully compliant and validated environment. All developers should have proper CSV training. All coding should be conducted under approved code development procedures including documented requirements, designs, code review and unit testing normally required.
- Fully documented IQ. Provide the appropriate installation qualification documentation in unexecuted and executed forms.
- Fully documented OQ. Provide the appropriate operational qualification documentation in unexecuted and executed forms.
- Fully documented PQ. Provide the appropriate performance qualification documentation in unexecuted and executed forms.
- Documented traceability matrix. Provide a bi-directional matrix from requirements through PQ testing.
- Validation registry. Uniquely document all deliverables as part of the validation package.
- Validation report. Create a final validation report that not only outlines the validated product and observed deviations and resolutions but also the known product limitations to help a customer understand the extent of validation.
LabVantage has offered such a pre-validated solution (SQL*LIMS P4) for nearly two years. It has been successfully implemented by a number of customers who have been able to recognise the full potential of this innovative concept. The image illustrates real-world time and cost savings. On a LIMS implementation with an estimated cost of US$600,000, the savings would be around US$480,000 and a start to go-live timeframe reduced from eight to 18 months down to fewer than three months. SQL*LIMS® P4™ Plug and Play Pharma Package contains over 3,000 pages of required documentation that the customer does not have to create to be fully validated.