Business requirements Building a Smart Laboratory 2012


Table 2: Typical documentation for a LIMS validation Document Name


System Risk Assessment Validation Plan


Outline Function in Validation • Documents the decision to validate the LIMS or not and the extent of validation work to be undertaken


• Documents the scope and boundaries of the validation effort • Defines the life cycle tasks for the system • Defines documentation for validation package • Defines roles and responsibilities of parties involved


Project Plan User Requirements Specification (URS) System Selection Report


Functional Risk Assessment and Traceability Matrix


Vendor Audit Report Purchase Order Configuration Specification Software Module Specifications


Technical Architecture (Technical Specification)


Installation Qualification (IQ) Operational Qualification (OQ)


LIMS Application Configuration Data Base Population


Module Testing and Integration of Custom Software


Data Migration


User Acceptance Test (e.g. PQ) Test Plan


PQ Test Scripts


• Outlines all tasks in the project • Allocates responsibilities for tasks to individuals or functional units • Several versions as progress is updated


• Defines the functions that the LIMS will undertake • Defines the scope, boundary and interfaces of the system • Defines the scope of tests for system evaluation and qualification


• Outlines the systems evaluated on paper or in-house • Summarises experience of evaluation testing • Outlines the criteria for selecting chosen system


• Prioritising system requirements: mandatory and desirable • Classifying requirements as either critical or non-critical • Tracing testable requirements to specific PQ test scripts


• Defines the quality of the software from supplier’s perspective (certificates) • Confirms that quality procedures matches practice (audit report) • Confirms overall quality of the system before purchase


• From supplier quotation, selects software and peripherals to be ordered • Delivery note used to confirm actual delivery against purchase order • Defines the initial configuration items of the LIMS


• Defining the configuration of the system policies • User types and access privileges • Default entries into the audit trail defined


• Specifying a custom module and how it will integrate within the LIMS • Coding and documenting the module to pre-defined standards • Informal developer testing and correction of the module code


• IT platform(s) defined, e.g. terminal servers, database server together with resilience features • Operating systems and service packs • Operating environments: production, validation, etc.


• Installation of the components of the system by the IT and the LIMS supplier after approval • Testing of individual components • Documentation of the work carried out


• Testing of the installed system • Use of an approved supplier’s protocol or test scripts • Documentation of the work carried out


• Configuration of the LIMS application according to the configuration specification


• Controlled input of methods to the LIMS • Controlled input of raw material, intermediates and in-process control sample and finished product specifications to the LIMS


• Formal testing of the module against the software design specification • Integration testing with the LIMS application


• Identification of the data elements and fields to migrate from an old LIMS, e.g. specifications, results, ongoing stability studies • Planning and executing the work • Confirming the successful data migration


• Defines user testing on the system against the URS functions • Highlights features to test and those not to test • Outlines the assumptions, exclusions and limitations of approach


• Confirmation of software configuration • Test script written to cover key functions defined in test plan • Scripts used to collect evidence and observations as testing is carried out • Documents any changes to test procedure and if test passed or failed


User Training, SOPs and System Documentation


Service Level Agreement (SLA) User Training Material


Validation Summary Report


• Procedures defined for users and system administrators including definition and validation of custom calculations, input of specifications, account management and logical security


• Procedures written for IT related functions • Practice must match the procedure


• Agreement between the laboratory and IT for IT and infrastructure services for the LIMS


• Initial material used to train super users and all users available • Refresher or advanced training documented • Training records updated accordingly


• Summarises the whole life cycle of the LIMS • Discusses any deviations from validation plan and quality issues found • Management authorisation to use the system • Release of the system for operational use (this can be a separate release certificate in some organisations)


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