Information Technology
Information Technology is the critical backbone of any life science company for collecting, archiving and analyzing complex business data. We offer detailed assessments and technology roadmaps to identify your organization’s critical needs, a full range of Qualification and Validation services for all types of computerized systems ranging from stand-alone manufacturing systems to Enterprise systems. We work with your teams to generated all necessary validation/qualification documents or provide a Subject Matter Expert (SME) review service to review validation/qualification documents generated by others.
In line with the industry accepted Risk Based Approach we conduct risk assessments to define appropriate levels of qualification and validation documentation and testing.
See the section below for a summary of the Qualification and Validation service provided.
Content
Computer System Validation
We provide the complete range of validation services for all types of computerized systems including but not limited to the following:
- Enterprise Systems
- Enterprise Quality Management Systems (EQMS)
- Stand-alone laboratory systems/equipment
- Laboratory Information Management Systems (ELN, LIMS)
- Chromatography Data Management Systems
- Information Management Systems
For all computerized systems we provide services to develop, technical review or maintain the following CSV Lifecycle documents:
- User Requirement Specifications
- Computer System Validation Plan
- Functional Requirement Specifications
- Detailed Design Documents
- IQ / OQ / PQ Test Protocols
- Computer System Validation Reports
- Traceability Matrix
Finally we provide a service to execute or review IQ/OQ/PQ Test Protocols while managing or reviewing all associated validation deviations.
Computer Software Assurance
IRLCA can manage your entire Computer System Validation (CSV). Whether you are still using the traditional CSV approach or ready to take the first steps to a more modern CSA approach to improve your quality and efficiency, we can help!
To harmonize with international standards, the FDA’s Center for Devices and Radiological Health (CDRH) plans to release a new draft guidance, “Computer Software Assurance for Manufacturing, Operations, and Quality System Software,” that aligns with the current quality systems regulation ISO 13485. With the FDA changing focus from compliance to quality and encouraging the use of automation and new technologies, IRLCA is already modernizing and practicing a more streamlined approach to CSV and in the process of updating our Cloud Assurance methodology to include a true, risk-based, CSA approach. We can help you develop your CSA approach too!
Infrastructure Qualification
We provide the complete range of services to ensure infrastructure used in regulated environments is appropriately qualified. The range of services include the following:
- Preparation and maintenance of the Infrastructure Qualification Plan, summarizing how the qualification of all relevant infrastructure components will be achieved.
- Preparation and maintenance of the Infrastructure Requirements Specification that defines all the requirements of the infrastructure landscape.
- Expert assistance in preparing the Infrastructure Design Document, including the design of the server/storage landscape, the network architecture, the backup/restore solution and the Disaster Recovery solution.
- Preparation and maintenance of the Infrastructure Configuration Specification that documents the exact configuration of the infrastructure.
- Preparation of the IQ and OQ Tests Protocols used to qualify all relevant infrastructure components.
- Execution of all relevant IQ and OQ Test Protocols.
- Preparation and maintenance of the Infrastructure Traceability Matrix.
- Tracking and management of all qualification deviations.
- Preparation and maintenance of the Infrastructure Qualification Report summarizing all activities conducted to qualify all relevant infrastructure components.
IT Framework Design
The role of a well-designed IT Framework should not be underestimated by any IT group aiming to maximize the value delivered to the business with minimum resource allocation.
The development of the right IT Framework requires a broad range of knowledge and expertise ranging from a detailed understanding of regulations, value stream mapping, process design, detailed IT operations, compliance group requirements, governance, human behavior, automation technologies etc. This knowledge and expertise defines Irlca’s core expertise and we provide a service that can confidently design and deliver a custom IT Framework that will meet your specific requirements.
