Our people are experts at reducing the weight, cost, and struggle normally associated with doing business in regulated industries. Our breadth of experience, and inability to sit still when we spot inefficiencies translates to time and overhead savings for our customers. We are fang-toothed project managers, analysts with many hats, detail-oriented validation experts, creative problem solvers, clever metricians, and what-if visionaries. Above all, we deliver results.
We are trained and practiced in a variety of disciplines associated with FDA and ISO regulations including cGMP, cGLP, Part 11, Annex 11 (EU), ISO9001, ISO14001, and ISO27001. We have deep experience validating risk-assessed processes. We can set metrics with meaning and mine the data to give them life. We have experience using the solutions we deploy in the lab, the office, and the manufacturing floor.
We know the technologies, solutions, and behaviors required to operate in our market space, and we have aligned ourselves with specific, strategic partners to maximize our ability to deliver the right solution at the right time.
Our People - Profiles
Ryan J. Coleman, Principal Consultant
Ryan is an expert at delivering effective, useful technology products. He is also adept at employing process optimization techniques to achieve better return on your technology investments and to increase your productivity.
His defining skills include streamlining process and practice activities in the healthcare business, marketing, biotech, and regulated pharma operations, manufacturing, and analytics environments. He possesses deep and uncommonly broad experience with cGLP/cGMP/ISO operations. He has a proven record of recognizing and implementing best-fit technologies in accordance with SDLC Project Management best practices, managing high-performance project teams, and getting the most value from a diverse array of vendors.
He has built a functional PMO from the ground up, deployed MOSS and MOPS 2007 and lived to see them deliver, and set metrics-based performance management standards at an enterprise level.
He has demonstrated healthcare marketing and management expertise by building successful systems and teams that meet the key requirements of speed to market and strong regulatory (HIPAA) and quality standards.
Ryan is a certified ISO27001 Lead Auditor
Alyssa Lagodney, Senior Consultant
Alyssa has over 6 years experience in the pharmaceutical industry, with a special focus on cGMP process validation, including LIMS systems and electronic batch record (eBR) validation. She has mastered risk-based approaches to the validation of complex, fully-integrated eBRs (MCS, Asset Mgmt system, data historian, business/accounting systems) and has demonstrative BA experience analyzing and defining diverse requirements from multiple organizational units into cohesive, actionable documentation.
She has also implemented and deployed MES equipment tracking and employee training applications. This includes the development of complex cleaning, calibration, and maintenance workflows, as well as reporting on the equipment status and operator training completion status.
Additionally, she has worked with Business Process Management software to develop efficient business workflows for routing, approval, and archiving of various cGMP documentation in the most challenging of organizations.
Further experience includes environmental health and safety (EH&S), DEA reporting, corporate accounting, and human resources. She also has over 2 years experience performing financial statement audits and SOx compliance work in the financial services industry for a Big 4 public accounting firm.
Tanya Coleman, Administrative Contact
Tanya has over 10 years experience in the healthcare field. In her current capacity at Dayspring, she keeps the back office afloat, and she does it well.
- Multiple LIMS System validation projects, Millipore, Inc.
- Quality System design and configuration, Auxililum, Inc.
- Vendor Audit of an SPL software provider, Alvogen, Inc.
- ERP Package Validation Strategy Consultation, SPI Pharma, Inc.
- Project Management Consulting, Emerson Process/Merck and Co.
- Validation Strategy Consultant, PMRS, Inc.
- Validation Lead, Bristol-Myers Squibb Company
- Validation Lead, Lonza Biologics
- MES Implementation Lead, Lonza Biologics
- Business Consultant, Proconex, Inc.
- MES Implementation Lead, Johnson & Johnson Companies