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 generate 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.
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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, 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 have a team of experts who can help you develop and implement your CSA approach for Production and Quality System Software projects. Computer Software Assurance (CSA) is a new approach to software validation that focuses on product quality, patient safety, and speed to market for computers and automated data processing systems used as part of medical device production or the quality system. CSA helps you reduce unnecessary documentation and testing activities, while ensuring that your software meets the regulatory requirements and performs as intended. CSA also enables you to leverage digital technologies and innovative testing methods, such as unscripted and automated testing, to streamline the validation process and achieve faster deployment and return on investment. This new approach is based on critical thinking and risk-based assurance, which means that you can prioritize the features and functionalities that are most important for your software and your customers. CSA is not a replacement for Computer System Validation (CSV), but rather a more efficient and effective way to perform CSV. Our CSA services are aligned with the FDA’s guidance on Computer Software Assurance for Manufacturing and Quality System Software.
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.
