Computer systems, software and instruments regulated by authorities such as the FDA require “validation”. Each company must decide how thorough their validation of LIMS needs to be. This is typically recorded in a Validation Master Plan which sets out the multiple steps that are necessary to ensure that the deployed LIMS is both validated and maintained in a "validated" status throughout its lifetime and subsequent decommissioning.

“Validation” is documented evidence that the LIMS does what it is supposed to do.  Every end user ‘validated site’ is required to develop a validation plan for their LIMS.  Your Company may choose to perform the validation using internal resources or hire Autoscribe Professional Services or hire a 3rd party organization to perform and/or help with portions of the validation.  Autoscribe cannot perform the entire validation, but can provide help as outlined below.

Typical LIMS Validation steps include:

• Master Validation Plan
• Validation Plan (includes Requirements, Design & Testing)
• Quality Audit of the Supplier
• IQ – Installation Qualification
• OQ – Operational Qualification
• PQ – Performance / Process Qualification
• Training, Support, Maintenance, Backup & Upgrade Procedures
• Validation Summary Report

Master Validation Plan / Validation Plan
Your Company will be responsible for authoring the Master Validation Plan / Validation Plan which includes the LIMS user requirements, design and testing needs and outlines the plan for validating the system. Typically, your organization will perform the work involved in producing this document. Autoscribe can assist in the preparation of this document.

Quality Audit
A quality audit is an audit performed by your company of Autoscribe to insure that Autoscribe provides high quality products.  Often this involves a one day visit to Autoscribe to inspect Autoscribe’s quality procedures (based on ISO9001:2000) and adherence to the procedures.  This visit is typically followed by a written quality audit report.

IQ - Installation Qualification

IQ is documentary evidence that the installation of the LIMS Hardware and Software was performed properly.  Your Company is usually responsible for the installation of the Server and Client Hardware, Network Communication Hardware, Computer Operating Software and Client Software. 

IQ confirms that the software was installed successfully according to the Autoscribe's specifications for correct and reliable functioning. IQ confirms that:

• The correct software version, system components and products are installed on the server and clients.
• Any expected system parameters are set.
• Required file structures, directories, and databases are installed as per Autoscribe's recommendations. 
• The correct security profiles are set up.
• Interfaces to any other systems are working correctly.
• The Autoscribe system does not negatively impact other systems.
  

Autoscribe will provide instructions for the installation of the Client software and will install the Matrix LIMS database components on the server using published procedures.  As a result, your Company or a 3rd party organization using the information that Autoscribe provides should be able to manage the IQ documentation or we can write it for you.

OQ – Operational Qualification
OQ is usually the most time consuming activity of the LIMS validation phase.  OQ involves the thorough verification and documentation that each function of the LIMS operates as designed according to the requirements and/or manufacturing specifications.  Autoscribe can perform much of the OQ step and deliver documentation, as well as test scripts that will be required to test the LIMS now and in the future, after updates.  The documentation that Autoscribe, provides along with the OQ report that is authored by you, usually is sufficient for the OQ of your LIMS system.

PQ – Performance / Process Qualification

PQ shows that the LIMS operates properly in the customer’s environment using the customer’s SOPs, Training, Instruments, Methodologies etc.  Autoscribe typically does not perform the PQ step of validation.  Customers will perform PQ for themselves, or use a 3rd party organization to perform the PQ. Autoscribe can provide labour (under your control) to perform these tasks but your company will be responsible for witnessing the PQ tests, the documentation and all acceptance and sign offs.

Training, Support, Maintenance, Backup, Disaster Recovery  & Upgrade and Decommissioning Procedures
The initial and ongoing Training, Support, Maintenance, Backup, Disaster Recovery  & Upgrade and Decommissioning Procedures of the LIMS must be documented, either as a separate document or included in the LIMS Validation Summary Report.

LIMS Validation Summary Report
The LIMS Validation Summary Report provides an overview of what was accomplished and concludes the documentation.