Life Science consulting that’s reducing the cost of compliance
With a highly skilled, diverse, and experienced workforce Affiliations with ISPE, GAMP and PMI
In Partnership with with ISPE, GAMP and PMI
We are a global ISO 9001 / 27001 certified company Trusted Advisors We sustain clients through smarter operations and our successes flow from our culture of transparency and respect for all. Focus on the Results We are global leaders in the Life Science industry with an ambition to shape the reality of the future. We are transforming how regulated industries are doing business. Efficient & Reliable IRLCA delivers on time. We are more than your vendor; we wear the T-Shirt and are your trusted partner. We share in your success as well as your challenges. We believe in a culture of Open & Honesty, Integrity and Respect. Technology as an Opportunity Through technology and compliance solutions, we empower our clients to turn strategic vision into executed reality. With the years of experience, IRLCA are developing in house disruptive technological solutions to increase compliance while driving down cost. IRLCA at a Glance IRLCA transforms enterprises through technology innovation, we sustain clients through smarter operations and our successes flow from our culture of transparency and respect for all.
Our Approach Strategy Our highly experienced team of industry leaders, including former operators, design a program and action plan customized to your needs. People We bring thought leadership to every service we provide. Our teams comprise of execution- focused system matter experts from industry. Success We partner with leading healthcare companies to ensure our skills enable our clients safe and reliable access to the world’s life-saving healthcare. Deployment We get the right boots on the ground, exactly where you need them across the globe, when you need them. Implementation We don’t just advise you on how to achieve a successful outcome, we deliver the strategic objective on time and get there together. Management You can count on our professional services program leaders who have deep experience with clients to oversee execution and manage tactical work streams through to a successful completion. 1. 2. 3. 4. 5. 6.
IRLCA Life Sciences Michael Schofield Co-Founder & MD at IRLCA Life Sciences At IRLCA we do things differently, so you can thrive. We start by hiring differently. We reach outside the usual recruitment channels to foster diversity and passion. “Through close collaboration with your internal teams, our partners, and the experts within our global consultant network, our regulatory, compliance, and quality specialists guide you to practical solutions that ensure quality, speed, and lower risk as the work is done.”
Regulatory Compliance Services IRLCA offer a range of compliance services to minimize risks to your company. QMS Transformation • Business Process Improvement • ISO Certification • Quality Risk Management • Capacity, Deviation and Document Management Pharmaceutical Audit • Internal Audit • Service Provider Auditing • Audit Readiness • Audit Support Resourcing & Professional Placement • Business Process Analyst • Business Analyst • Quality Assurance Quality Assurance Management • Digital Interface • Inspection Requests Training and Learning • Pharmaceutical E-Learning • Training Management • Quality Project Management • Technical Writer IRLCA Life Sciences Services
Life Science Systems and Services Enterprise Systems Automation • Enterprise Document Management • Enterprise Content Management • Enterprise Learning Management • Electronic Lab Notebook Lab Informatics Digitalisation • Laboratory Validation and Compliance • Laboratory Technical Support IT Innovation • Computer System Validation • Computer System Assurance • Infrastructure Quality The client identified that their current electronic document management system had been identified as the fifth highest business information risk on the company risk register due to its nature of high application support as it was on-prem system and ad hoc patch deployments by the vendor. The system poses risks to critical business processes if left unremediated. Challenge Life Science Systems and Services Case Study
Technology is changing the future of Life Science. We offer a broad range of strategic solutions to meet the needs of Life Science organisations. Our consultants provide the experience & expertise to guide our clients to operational excellence. P/CMO • Project/ Programme Management • Change Management • Project Support Application Lifecyle Management • Problem Management • Knowledge Management • Identity and Access Management • Patch Management Professional Placement • Tech SME • Configuration Specialists • Project Managers • Business Systems Analyst • Security Management • Change Management • Backup & Recovery • Audit Support The system is scalable in alignment with future expansion expectations of the business. Significantly greatly increased the uptime of the system to the businesscritical areas and reduction in cost of maintenance and application support as the system is a SaaS solution and moved offprem. Initially will support 3000 users with scalable storage and fast processing of a 3 second processing time for actions on documents. IRLCA conducted a sourcing project to recommend and implemented with the client an industry standard electronic Document Management system that enabled the client to manage electronic documents in a controlled way throughout their lifecycle. IRLCA managed the implementation process with the vendor and the client on the project management front, Technical Solution Design, CSV validation and Migration of the data from the source system to the new system. The chosen system was delivered as a SaaS solution maintained in the cloud by the chosen vendor. Solution Benefit
IRLCA Technologies Desmond Farrell Co-Founder & MD at IRLCA Technology Development At IRLCA we do things differently, so you can thrive. Technology Innovation is our Mantra, it’s who we are. Built on a core platform and delivered as SaaS, the IRLCA Application Suite empowers Pharmaceutical Lifecycle Operations to be designed, operated, monitored, evaluated and continuously improved with a Risk Based Approach at reduced cost. Optimises your Operations Better Outcomes at Reduced Cost IRLCA’s SaaS Applications built on ‘IRLCORE’
A modern WEB application providing a fully integrated solution Inspections More… Risk Management Audits CAPA Training Procedures Deviations Change Control Documentation Quality Review Complaints Supplier Management Complaints Product Release Clinical Trial iQMS Complete, Manage and Control all of your QMS activities through iQMS
Industry Response Join the Revolution INDUSTRY RESPONSE optimises inspection readiness and Inspection intelligence. Audits and Inspections are managed through the phases of planning, preinspection preparation, inspection, closeout and observation remediation. Lessons learned are analysed and embedded into future audit and inspection Management
Solution In Action Manage and control all of your Audits and Inspections in one place with Industry Response
Active Risk Management Join the Revolution ACTIVE RISK MANAGEMENT optimises Risk Assessment and Risk Identification. Risks are recorded, analysed and evaluated in a standard way enabling focused Risk Management across the organization at all levels from Operational to Enterprise.
Solution In Action Complete your whole Risk Management Lifecyle in just one place
IRLCA Learning & Development Grace Kennedy IRLCA Head of Learning & Talent Development At IRLCA we live for those “light bulb” moments! We believe learning is a critical element of powering innovation. At IRLCA we do things differently, so you can thrive. This industry moves fast, and things are changing all the time. Through close collaboration with our clients and industry partners, we have developed a nimble, real-time and more individualised career path that reflects who we are and ensures our team are best positioned to support your business needs.
IRLCA Academy When joining IRLCA you join the IRLCA Academy, a well-rounded, levelled program that equips our people with the industry knowledge, technical competency, and critical personal and interpersonal skills required to stand out from the crowd! Software Development Academy Life Science Academy Building competency and laying the foundations of industry knowledge and experience through in-house training from industry experts, external certifications and On-The Job training and mentoring Discovering and pursuing your speciality, while staying grounded and up to date in the fundamental competencies to remain a multidisciplined consultant who can analyse, plan, implement and lead complex projects across the Industry.
How can IRLCA help your business thrive? Are you looking to improve processes to increase efficiency? Do you need knowledgeable and technical domain experts to reach your goals? Do you need support conducting data analysis that contributes to better decision making? Do you need support navigating the regulatory challenges with storing and managing data? Do you need help embedding change and building organisational capabilities? Need someone to take the reigns, manage and drive critical organisational projects? Need guidance on regulatory requirements and changes to ensure your business is compliant? Implementing new software or equipment and need support with the qualification and validation lifecycle. But don’t take our word for it… IRLCA are global leaders in the Life Science industry. We are transforming how regulated industries are doing business by providing Life Science Consultants who are experts in Quality Management and Security Management systems. Along with years of experience, we are developing in-house disruptive software applications for the Life Science Industry.
“I am really pleased by the support Walid is bringing to my program. From the start of the project there was a lot of ambiguity and a lot of disruption as you can imagine happens in integrations, but Walid has successfully navigated each disruption and pivot with tremendous agility and aptitude. As you probably know directly, Walid has many incredible strengths –he is an exceptional listener, a critical analyst and has a true passion for delivery. Walid accepts feedback freely and is categorically self-aware in all professional settings where he is able to step in and out of conversations with keen intention to add value and drive results. Ian has been an over achiever in his OpEx and Smartsheet role on my team. I have tasked him with learning new capabilities while implementing them into solutions and he has done in with excitement and enthusiasm. This year Ian has made a fabulous amount of progress in soft and social skills from a customer perspective. Ian is an extremely intelligent and technical resource for my team, but I challenged him by creating an environment that necessitated him interacting with our customers on a regular basis from a project team member perspective and a teaching resource. In both of these areas he excelled with minimal guidance and feedback. Ruairi has been an exceptional utility resource for our Central Quality team this year. He’s spent time on 3 major initiatives: Smartsheet Support & OpEx Pilot Program BA, Dicerna Integration Project, OpEx BA. In these roles, Ruairi showed impressive ability to change tack quickly and efficiently as the business needs changed. He was instrumental in building out our first Operational Excellence tool within Smartsheet for the Notification to Management team. We hope you’ve enjoyed being a PM on an asset integration project team, and learned a lot about how we actually employ and use the Smartsheet tools. Thanks for your tremendous support and we hope it was a good experience on the Dicerna team” check out what our clients have to say! I wanted to thank you and your team for all the amazing support and work that your team provides for us. Each individual I’ve worked with is extremely knowledgeable, very professional, and pretty darn fun to work with!
Contact us: [email protected] www.irlca.com DUBLIN Irlca Limited Block 14, Joyce Way, Park West, Dublin 12 Ireland, D04 C7H2 BOSTON Irlca Inc., One Lincoln St, Boston, MA 02111, USA.