We can “Do IT” as well as “Manage IT” for you
We partner with our customer’s Business & IT Teams to plan and deliver a solution suited to their needs.
Our focus is delivery and customer satisfaction. We have a proven track record of on-time and in Budget project delivery.
We offer excellent cost effective application support & maintenance services. Our dedicated team of IT professionals provide remote support and maintenance for your applications.
We focus on comprehensive application management to improve end user experience.
TECHNICAL IMPLEMENTATION
We are one of very few consulting teams that have an in-depth understanding of not only Information Technology, but also the business processes, systems, applications, and tools that are used in the Life Sciences industry today.
Full-cycle IT Project Implementations
Bringing to bear our network of skilled and experienced resources we are equipped to provide full-cycle IT project implementations for our clients.
Building on the specific consulting services we are known and respected for we can bring in the additional team members necessary to drive IT projects through the full System Development Life Cycle.
Specialized Pharma System Implementations
Strategy for Regulatory Information Management Systems.
Gap analysis and Implementation strategy for R&D Applications.
Data Migration for Drug Safety & Regulatory Data.
PROJECT MANAGEMENT
We partner with our customer’s Business & IT Teams to plan and deliver a solution suited to their needs. Our focus is delivery and customer satisfaction. We have a proven track record of on-time and in Budget project delivery.
Evaluation
High Level Requirements
Request for Proposal (RFP)
Vendor Analysis & System Selection
Planning
Setup Project Steering Committee
Project Charter & Project Plan
Budget Resourcing
High Level Architecture
Implementation
Regular Status Reporting to Stakeholders & User Group Meetings
Technical Implementation in Development & Validation
System Requirements, Configurations, & Design
Formal Validation including GxP protocols
User Training & SOP Development
Post Implementation Support
Close out
Project Documentation Archive
Survey – Lessons Learned
Go-Live Support
VALIDATION
Accuvalent prides itself as experts in validation and implements all the programs to the highest GAMP 5 standards.
GAMP 5 Validation Methodology
We support all facets of the risk-based GAMP 5 validation standard for compliant GxP computerized systems.
We help our clients to effectively & efficiently manage & perform Computer System Validation projects to industry best practices and FDA requirements.
Expertise
GxP Assessments
Change Control
Validation Planning, User Requirements, and Design Specifications
Installation, Operational, and Performance Qualification
SUPPORT AND MAINTENANCE
Our services are tailored to suit the application, its lifecycle stage and users’ needs.
IT-R&D Application Support
We offer excellent cost effective application support & maintenance services. Our dedicated team of IT professionals provide remote support and maintenance for your applications.
We focus on comprehensive application management to improve end user experience.
We have the knowledge base to support Regulatory, Quality, Adverse Event & Dictionary Management, and Clinical & Bio Statistics.
Application Support & Maintenance Services
We line up with customer support and administration procedures.
We focus on overall system health, we believe that only a well-maintained system can improve user experience.
We work with both on call (retainer based) and dedicated support models.
Our comprehensive application management covers ramp up, system administration, regular maintenance, break-fix, and periodic service reviews.
