For most companies, a successful future depends on solid project management. Following the PMI methodology, our Project Managers can:
- Develop Project Charter and Scope documents
- Create Project Management Plans, Work Breakdown Structures and Gantt charts
- Manage deliverables, implement change requests, and address CAPA
- Maintain Project Scope documents and Project Management Plans plus provide performance reports and forecasts
- Report on lessons learned and project closure
Computer System Validation
Our history in the industry, knowledge of government regulations, and experience with global validation projects make GxP Partners a validation partner with the credentials and expertise you require.
- GxP Partners Computer Systems Validation Methodology provides a start-to-finish solution for validating systems following GAMP (Good Automated Manufacturing Practice). Our validation methodology offers everything you need, including policies and easy-to-use templates that guide you through the process from planning to “go live.”
- GxP Partners methodology gives you direct access to our years of experience validating computer systems that comply with requirements of ISO, cGMPs, 21 CFR Part 11, HIPAA, Sarbanes-Oxley, and other regulations.
GxP Partners – Project Management and Validation Services
Knowledge / Experience / Dedication
- Project Management
- Requirements Gathering Workshops
- Streamlining/harmonizing processes
- System development (highly skilled system developers)
- Validation (CSVP) – as much or as little as you need)
- URS / FRS
- Validation Plan
- Detailed Design Specification
- IQ/OQ/PQ development
- Risk Assessment
- Trace Matrix
- Summary reports
- Basic Designer Training
Customer Success Stories
Fujitsu, a major telecom organization was transitioning from spreadsheets and Access databases to an integrated quality management system (QMS). The solution implemented by GxP Partners automated incoming inspection of material, material review board forms and workflows, document management, inspector training, and supplier rating scorecards. Rather than relying on email attachments, the solution provided an interface for suppliers to respond directly to their Supplier Corrective Action Requests (SCARs). The new approach reduced the number of open CAPAs by 50% and reduced the number of days open by 72%.
Merck required computer system periodic reviews and hired GxP Partners to perform that for 12+ systems. This closed gaps they had to stay in compliance with internal procedures around how often computer system need to be reviewed to ensure they are up to date as well as all documentation surrounding that system are housed within the EDMS system and not lost.
MilliporeSigma has been utilizing GxP Partners since 2005 off and on for PM and/or CSVP. GxP Partners to assist in the implementation and validation of their QMS solutions. These entailed the retirement of existing systems, migration of data from existing systems, and validation of the replacement system. Work was completed on-time and under budget while ensuring compliance with FDA consent decree requirements. GxP Partners also assisted in implementing a label system and currently assisting in a data historian implemtation.