Solutions
Enterprise & Lab Solutions
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.
Manufacturing IT
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.
We provide experienced resources to assist in managing, maintaining, automating your MES, ERP/SAP and data software systems.
Our team can help optimize your software for productivity and growth by assessing current processes and procedures.
We support the management of IT project planning and implementation for short and long-term projects.
We facilitate the development of all CSV life cycle deliverables in compliance with the governing regulations and industry best practices (GAMP5, PIC/S, ICH).
We can deliver Quality as a Service, an outsourced model delivering quality functions in a MSP (Managed Service Provider) model.
Clinical
As you move from research to clinical trials, your processes must incorporate data and process compliance in their design. Our business analysts can help gather requirements for applications, data, and processes. Our expert team of quality analysts and auditors can help to ensure that you are compliant from the start. As you move from clinical trials to commercialization, our CMC experts can guide you in tech transfer, scaleup activities, and help you manage CRO, CMOs and other vendors to ensure that you are always in a state of control. We cover all aspects of manufacturing, including machine automation and validation, vision inspection systems, purity and batch record compliance activities, fill and finish advisory and implementation as well as your full supply chain. We can also assist, or manage for you, analytic development activities.
We can provide CMC advisory including quality control and assurance as well as leadership and vendor management and strategies.
Our experts can provide strategy and advisory for tech transfer and scaleup including selecting, managing, and auditing CMOs.
We provide business analysis and program management as well as process design for a host of clinical applications.
Our team can work with your, or manage completely, your eTMF data, applications, and processes.
Commercial
Companies preparing for their first go to market drug need to develop new front-office capabilities for product launches, new selling models, and product acquisition. Mature companies that expand into new markets require planning and execution to integrate new therapies with existing commercial footprints.
We help companies understand this business evolution from both a maturity and marketplace perspective. And we help solve the difficult technical challenges this creates. We define right-sized strategies and solutions with a keen focus on the full scope of commercial business requirements.
We can help you effectively analyze and improve the commercial viability of your products through commercial launch planning and strategy programs.
Our team of experts can help you select commercial processes and tools for every aspect of commercialization, including enterprise data lakes and warehouses.
We can help you to enable your field force with guidance in CRM, Market Access, Digital Enablement and Territory and Roster processes and toolsets.
We cover all aspects of commercial manufacturing from CMC activities to packaging and serialization as well as 3PL and distributor integration. We are unique in that we can help you from the factory floor with vision inspection, automation, and validation to the board room with strategic planning and road-mapping – and everything in between.
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.
