Ensuring quality in the technology systems that support drug discovery, research, clinical, and commercial operations.
Whenever patient safety is involved, IT systems are subject to extreme scrutiny by government agencies to demonstrate strict adherence to applicable rules and regulations. Our focus is always on patient safety, product quality, and data integrity. We offer an industry proven based Quality Risk Management approach to ensure projects are right sized for risk and ensure systems are fit for their intended use.
Your computer system validation initiatives can leverage our world class subject matter experts to skillfully validate and maintain your business and mission critical information systems, including Quality Management Systems, Enterprise Resource Planning, Customer Relationship Management Systems, Learning Management Systems, Document Management, etc.
Throughout the system lifecycle – from concept, planning, business process analysis, specification development, build/configuration, testing, production release, and operational change management -we develop procedures, assist with operational change and incident management activities, perform periodic reviews to ensure the system continues to operate in a validated state, and support re-validation efforts.
We partner with client stakeholders to identify system and data integration requirements, define specifications, and conduct verification activities to ensure the integration is performed to specifications.
We provide support throughout the data migration process, including analyzing legacy data, remediating data quality issues, preparing data migration plans / test plans, and conducting data verification activities.
Our team has extensive experience with Planning, Executing, and Managing Legacy Computer Validation and 21 CFR Part 11 / Annex 11 Gap Analysis and Remediation programs.
We can deliver Quality as a Service, an outsourced model delivering quality functions as an MSP (Managed Service Provider) model.
Lab & Informatics
Optimizing and integrating laboratory and informatics systems is a difficult and complex undertaking. We help clients achieve laboratory excellence by providing expert compliance services in the areas of LIMS, ELN, SDMS, CDAS, laboratory equipment and practices, including computer system validation, business analysis and definition, lab network support and lab operational support.
We perform a thorough review of the laboratory systems and their associated data paths to determine alignment to compliance and data integrity standards.
We provide experienced validation resources needed to create a compliant validation software package in alignment with the client SDLC (System Development Life Cycle Documents).
Our leaders guide validation efforts through the many compliance stage gates of the project lifecycle.
We institute a structured approach to extracting and aligning business process steps across a client’s workflow to provide a map of requirements and system steps necessary to create a working harmonized solution.
We create a structured compliant laboratory space and provide clients with a fully functional networked laboratory ready to collect data.
Ensuring your computer software system validation efforts associated with manufacturing data workflow and materials management operations is our priority. Our world class experts help clients with the design, configuration, implementation, and validation of their networked software platforms to ensure adequate fit for use in their business. We have decades of experience with large scale business critical logical systems including Manufacturing Execution Systems (MES), Warehouse Management Systems (WMS), Manufacturing Material Management modules of enterprise systems such as ERP/SAP, and environmental/building management data software systems.
Our world class experts help clients with the design, configuration, implementation, and validation of their networked software platforms to ensure adequate fit for use in their business.
Quality Management & Auditing
The successful delivery and confirmation of industrial and regulatory accepted quality systems for Pharmaceuticals, Biotech’s, Medical Device providers, and Clinical Support organizations requires resources, processes and technologies. Our consultants are experts in the development, enhancement and roll-out of client Quality Management Systems (QMS) including the associated policies and procedures, and audit expertise to support our clients internal and external auditing requirements.
We support clients internal auditing and gap analysis efforts with expertise in risk-based applicability against a defined QMS.
We support client inspection readiness preparation, hosting and post-inspection consultation / issue resolution. Our team has experience reviewing observations and constructing/implementing plans for regulator response and remediation.
We support client design, execution, reporting and follow-up of external (vendor audits).
Infrastructure, Cybersecurity & Digital Transformation
The control and management of a company’s infrastructure ensures that the backbone of all applications is maintained consistently and in a controlled manner – it is the foundation for all business applications. Our experts ensure that security and service management are built into all application environments.
We develop the policies and procedures necessary for the management of Infrastructure.
We develop specific requirements, design and testing to ensure that an environment functions as intended.
We develop the processes to define configuration items and the management of their changes.
We provide guidance and development on best practices on aligning IT Services with the needs of your regulated applications.
Our cybersecurity experts can provide guidance on the NIST Core Framework functions to identify, protect, detect, respond and recover in a secure environment, including risk management, data security, monitoring, mitigation and recovery planning.
Our digital transformation experts can improve your process/labor efficiency and overall cost position through implementation of electronic tools /applications. Our team can work closely with your process experts on a custom digitized solution, or can offer one of our standard solutions refined in-house.