We help our clients meet their key business objectives by enlisting automated workflows, compliance, privacy and security, and data-driven decision-making approaches. We support our clients’ technology ecosystem from strategy and software design through quality and regulatory support.We then deliver a future state roadmap that includes a technology vision to accelerate company goals, specific recommendations to address gaps and opportunities, a value and benefits analysis, and a high-level plan to implement objectives in a phased approach that minimizes disruption and leverages existing best practices.  We have access to the latest technology and trends to deliver the right, fit-for-purpose solutions as we know there is no one-size-fits-all when it comes to defining the technology roadmap.   

We provide a variety of services to support our clients’ Quality Management Systems and keep their technology programs inspection-ready at all times. Halloran develops and refines IT compliance processes, policies, SOPs, work instructions, templates and select/implement tools to help our clients effectively manage their infrastructure, whether in-sourced or outsourced.  We verify our clients’ compliance with 21 CFR Part 11, GDPR, and all relevant global regulations.

We provide the program leadership to implement agreed-upon changes and culturally move the organization towards greater compliance with our proven change management methodology. We manage the process of defining roles, aligning departments, building efficient workflows, and delivering a sustainable governance structure. We provide the training and internal communication plans to help implement this change across our clients’ organizations.

IT compliance processes we develop include:

• Backup/ restore
• Disaster recovery
• Access management
• IT change control
• Business continuity
• Risk assessment
• Physical and logical security
• Privacy
• Incident management
• 3^rd party quality agreements

We will review our clients’ existing Software Development Life Cycle (SDLC) processes and, if desired, implement our recommendations for improvements. We are experts at building quality into custom systems through leading requirements, configuration, and risk assessment workshops. We present actionable steps organizations can take to design software to be more efficient, secure, usable, and compliant with regulations such as 21CFR Part 11, HIPAA, etc. through workshops, demonstrations, and walk-throughs.

The following aspects of existing Software Development Lifecycle (SDLC) processes will be reviewed as part of our work:

• Artifacts to support inspection readiness
• Agile adoption
• SDLC and supporting SOPs/ Work Instructions
• Process efficiency
• Appropriate delineation of roles and responsibilities
• Integration of processes with overall Quality Management System

We partner with our clients to develop risk-based audit plans and provide detailed audit feedback that supports continuous improvement and inspection readiness. We conduct cost-effective Computer System and IT Compliance audits for sites, partner technology vendors, and internal processes. We perform audits against 21CFR Parts 11, 211, 312, 820, Annex 11, GDPR and HIPAA as well as international standards such as ISO 14971, ISO 62304 and ISO 13485.  We are well-versed in assessing alignment with Good Automated Manufacturing Processes (GAMP5) best practices.

We partner with our clients to ensure the requirements of their organizations are met by the system being considered. We will aid in tailoring the vendor evaluation process from needs assessment and RFP creation to vendor identification, demonstrations, evaluation, and cost-benefit analysis. We leverage industry benchmarking data on costs and capabilities to recommend the provider that is the best fit for our clients’ budget, capabilities, processes, and people.

Leveraging our industry expertise and best practice experience, Halloran will develop a risk-focused and scalable 21 CFR Part 11 compliant computer system validation (CSV) program with an accompanying change control SOP to ensure the system remains in a validated state. Using our risk-based methodology, we will lead and execute the end-to-end process of computer systems and/or infrastructure validation, including planning, requirements, configuration, system SOP authoring, validation and reporting. We will assist in managing the vendor implementation process and act on our clients’ behalf to navigate any challenges.

We partner with you to implement the technologies along with the processes and resources necessary to create meaningful change for our clients. We follow a strategic change management methodology, incorporating program leadership, role alignment, new process documents, training, and communication strategies.

We partner with our clients to migrate regulated and operational data from legacy systems to new or replacement technology systems. Harnessing our depth of experience and industry best-practices, we have defined unique methodologies for performing data migrations that leverage subject matter expertise, custom data cleansing, and inspection-ready quality controls.  The migration process is guided by a Data Migration Plan while actual results are documented on verification scripts. A migration report summarizes the results and confirms the process was completed as planned, providing enough details and evidence to satisfy regulators or auditors.

Our experts assume interim roles of Head of Computer Validation, Head of Software Quality Assurance, or as the on-demand subject matter experts for IT Compliance support at our clients’ organizations. A non-exhaustive listing of services includes software development life cycle assessments, computer system validations, data integrity control planning, software design, interviewing, team building, inspection-readiness, mock auditing, regulatory awareness training, compliance planning, system use, maintenance, and administration.