Computer System Validation

Alfvo LLC is a women-owned IT staffing and services company founded in 2017, described as one of the premier privately held IT staffing and services companies on the East Coast. It provides project staffing, staff augmentation, recruiting, application support and maintenance, software and mobile app development, data analytics, and emerging technology solutions, and was recognized in Inc. Magazine's 2024 rankings of fastest-growing private companies in America.

Automation testingdata science consultingenterprise mobilityIT consultinglow-code/rapid application developmentmanual testingpayroll managementSaaS developmentsoftware developmentstaffing and recruiting

Alpharma Integrated Solutions is a consulting corporation firm with consultants with over 15 years of experience within the Pharmaceutical, Medical Device, and Biotechnology Industries. Since its inception in 2008, it has focused on providing compliance solutions to the regulated industry around the globe, offering a combination of life-science-specific business, technology, and regulatory expertise for a risk-based approach to compliance.

application developmentcalibration and metrologydatabase administrationfacility commissioning and decommissioningHVAC validationIT securitylaboratory equipment qualificationLIMS qualificationnetwork managementregulatory compliance consultingsystem integrationvalidation services

Astrix is a pharmaceutical technology services company that has helped life science organizations implement technologies for more than 30 years. It provides vendor-agnostic consulting, advisory, and expert services across research, clinical, regulatory, quality, and laboratory operations, including LIMS implementation, data management, and AI/ML solutions. The company states it does not sell or resell software.

AI/ML model trainingchange managementdata managementeCTD publishingIQ/OQ/PQ supportLIMS implementationprocess validationRIM implementationsystem evaluation and selectiontechnology transfer

BGASoft delivers cloud informatics solutions, software development, and validation for laboratories in regulated and non-regulated environments. It provides LIMS services spanning selection, implementation, validation, integration, and ongoing support for clinical, public health, and research laboratories, plus clinical trial systems and 21 CFR Part 11 computer system validation.

21 CFR Part 11 validationAI integrationcloud application developmentinstrument integrationLegacy system modernizationLIMS implementationsoftware developmentworkflow automation

cGMP Validation was established in 1997 as a full service validation/compliance firm serving the pharmaceutical, bulk pharmaceutical, animal health, biotechnology, biologics, medical device and medical diagnostic industries. It specializes in preparation and execution of validation IQ/OQ/PQ protocols and compliance documentation for equipment, utilities, processes, laboratory instruments, and computer systems, with clients across the US, Puerto Rico, Canada and internationally.

21 CFR Part 11Auditingcommissioningcompliance consultingdocument preparationfactory acceptance testingqualificationrisk assessmentsite acceptance testingtrainingvalidation

DynoVelocity consulting specializes in Project Management Consulting, Computer System Validation Services, Equipment Validation Services and GxP Technical & Quality Assurance Solutions for the Life Sciences Industries. They provide PMP-certified project leadership and have delivered projects for Fortune 500 companies across multiple international sites.

Equipment ValidationGMP, GLP, GAMP and 21 CFR Part 11 validationsGxP Technical & Quality Assuranceproject management consulting

Excel Engineering provides a full scope of electrical and automation engineering and consulting services under one roof. Since 1990, the firm has served industrial facilities across markets including life sciences, consumer goods, chemical, oil and gas, mining and mineral, and power and utilities, offering design, refinement, and implementation of solutions from initial discussion through deployment.

arc flash analysisconstruction managementcontrol panel design and constructiondata historian and plant dashboardsdynamic stability and EMT analysiselectrical engineering designindustrial process automationinfrared thermography inspectionsload flow studiesNFPA 70E trainingNRTL field evaluationsPLC/HMI and DCS platformspower system studiesProtective Device Coordinationshort circuit studiestransmission planning

FDA Quality and Regulatory Consultants (FDAQRC) is a provider of regulatory compliance solutions for pharmaceutical, biotech, and medical device companies globally. Its employees and consultants are experienced across all GxP areas, supporting clients at all product life cycle and development phases. FDAQRC offers quality audits, mock inspections, gap assessments, remediation services, and recruitment, pairing clients with experts through a global consultant network.

Gap assessmentsInspection readinessmock inspectionsqualification and validationquality auditsrecruitmentregulatory affairs consultingRemediation Services