LIMS Validation Services

Ensure data integrity and Certify systems compliance

 

Orbis Labsystems has over twenty-five years experience in the implementation and validation of LIMS in pharmaceutical manufacturing. We have experience of both new installations, integration to instruments and chromatography systems and system upgrade.

Our knowledge and practice is build on the principles of GAMP 5 and ISO 9001. Our offering is based on the GAMP V curve. Orbis provides each of the deliverables for a system shown on the curve. We will provide the User Requirements Specification, in association with the customer, the Functional and Configuration Specifications. We author Installation, Operational and Performance Scripts as well as Standard Operating Procedures.

GAMP V Curve

December 13, 2022:

Orbis recently partnered with ValGenesis to deliver best-in-class digital validation solutions for life science companies. ValGenesis is the market leader in enterprise Validation Lifecycle Management Systems (VLMS), helping the world’s leading life sciences companies enforce compliance and enable standardization with 100% digital, risk-based validation software. Our partnership creates an innovative and cohesive approach to digitizing validation, further strengthening risk and compliance processes across the laboratory.

Orbis LIMS Validation methodology has three foundations

Functional Assessment

Software Reliability

Risk Assessment, Causal Analysis, Mitigation and Testing

Risk Based Testing and Validation Process

A Systems Acceptance Test (SAT), before formal validation, is designed to assess functionality and software robustness. It is driven by the risk assessment and system functional and data lifecycles. The risk assessment identifies functional gaps and risks, not just expectation measurement but causal analysis so that sources of failure or gaps are tested.

Operational Qualification

The Operational Qualification (OQ) confirms the software as specified, i.e. functional completeness. For most functionality in leading LIMS/ELN the software vendor’s testing prior to the product release is accepted. This testing should be reviewed through an audit prior to the project implementation. The vendor will also have a suite of scripts available for vanilla testing of the product release.

Functional Completeness

We recommend a Functional, or Functional Response, Specification with respect to the User Required Specification, and in writing this document relevant functionality should be confirmed as any of Out of the Box, Configuration, Functional Extension or Customization. Where there is Functional Extension or Customization it will usually be outside the scope of the vendor testing and therefore require the authoring and execution of a specific OQ script.

The Functional Risk Assessment that follows the Functional Specification will call out additional specific OQ scripts that are required, because of functional extension/customisation, new and previously unused functionality with high operational impact or quality assurance concerns. All interfaces must be specifically OQ tested for data integrity.

Software Reliability

We recommend a Functional, or Functional Response, Specification with respect to the User Required Specification, and in writing this document relevant functionality should be confirmed as any of Out of the Box, Configuration, Functional Extension or Customization. Where there is Functional Extension or Customization it will usually be outside the scope of the vendor testing and therefore require the authoring and execution of a specific OQ script.

The Functional Risk Assessment that follows the Functional Specification will call out additional specific OQ scripts that are required, because of functional extension/customisation, new and previously unused functionality with high operational impact or quality assurance concerns. All interfaces must be specifically OQ tested for data integrity.

Process Qualification

The Process Qualification (PQ) tests the LIMS/ELN as deployed. Generally this is done through a scripted operational process, for example sample and test lifecycles, that confirm functionality called out in the User Requirements Specification / Test Matrix.

The scripts can be authored once the design is completed. This is important if there is functional extension. They can actually be dry run through the SAT process described above, if drafted and prior to approval.

Authoring Scripts

Orbis Labsystems has well proven templates for IQ, OQ and PQ validation. These are generated and managed through a document management system. Generally these scripts are dry executed to confirm that the processes therein are consistent with the software.

The scripts are subject to review, approval and control by the customer before execution. The script should define execution prerequisites, data for testing, inputs and expected outcomes.

Scripts Execution

The scripts should be written so that it provides the executor the process and steps to be followed.

Evidence of execution should be captured during execution and this is normally done through screen capture. The script should also note any discrepancies or deviations. The scripts are subject to review and approval post execution. Discrepancies and deviations will be logged on the customer quality management system.

Project Management

The validation program is integral to the project and should be an actively managed activity. In many projects there are multiple parties involved, including the project implementation team, external validation consultant(s) and internal quality assurance.

The validation time and effort is most likely as large, if not larger, than the implementation time for the solution. We focus on reducing this time by giving it specific focus in the plan, leveraging from similar projects and timely deliverables. As there are multiple parties time and availability of critical resources must be carefully planned.

Conclusions

  • We understand compliance with deep knowledge of leading international standards such as GAMP, HPRA, PIC/S and ISO. We use this knowledge in implementation and testing.
  • Our Mission is to bring the best sciences, information and systems engineering ability to help our customers achieve their business objectives with LIMS.
  • We have extensive experience of implementing LIMS in Pharmaceuticals, Food and Beverages. We use this experience in providing our customers with guidance and direction.
  • We work to best practice in configuration and data organization following processes that are ISO 9001 : 2015 certified.
  • Our technology skills ensure that we provide our customers with the best solutions whether its for LIMS configuration, integration, reporting or analytics.
  • Our experience in projects for over 20 years, whether large or small, allows us to bring recognized project management practice including full risk analysis of the project, solution functionality and data.

Knowledge Base

White Papers

Project Management

Project Management Orbis Labsystems focuses on optimum deployment of resources with risk management to ensure successful delivery of our solutions. We recognize that the two greatest challenges in a project are the quality of the requirements which drive the solution...

Project Planning and the Business Case

Project Planning and the Business Case With over thirty years experience in laboratory informatics Orbis Labsystems has a wealth of experience to guide our customers to successful outcomes with their projects. Each project assignment starts with an assessment of the...

LIMS Implementation

LIMS Implementation The actual solution assembly, normally called implementation, runs from requirements analysis to successful testing. Each stage is led by an experienced consultant with supporting and qualified resources, including where appropriate from the...

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