Management, complete life cycle documentation (from URS to PQ) and IT validation as part of the technical migration of a JD Edwards ERP platform. The mandate included the upgrading of both the virtual server environment and physical hosting infrastructure. It also involved ensuring compliance with current good pharmaceutical manufacturing practices for both U.S. and Canadian food and drug regulations.
- 24 weeks
- 6 virtual servers
- 33 ERP modules
- 820 applications
- 387 tables
- 20 reports
- More than 30 stakeholders involved
- More than 200 users trained
- 1 Go Live
- 0 unplanned service outages
The existing system was operating on an aging JD Edwards ERP platform no longer supported by the manufacturer. The virtual application servers were hosted by a group of physical servers that were becoming outmoded and needed replacement.
Since its initial validation, the software had undergone many custom modifications the documentation for which was incomplete. The existing system was supporting all of the companyâ€™s business processes:
Non-GMP commercial functions:
- Product costing
- Accounts payable
- Accounts receivable
GMP manufacturing functions:
- Change controls
- Incident reports and CAPA
- Standard operating procedures
- Address book
- Shipping & receiving
- Management of the Items Master and Lots Master
- Management of specifications and certificates of analysis
- Quarantine & release
- Warehousing & inventory management
- Management of Bill of Materials, planning and scheduling, as well as production work orders
- Printing of item identification labels
- Equipment maintenance management
- Preventive and corrective maintenance work orders
The transfer and Go Live would have to be carried out during a single weekend.
- A complete development environment was installed to run concurrent to the production environment. It included a new Storage Area Network (SAN), new virtual application servers and the new JD Edwards ERP platform.
- Mapping of all existing modules was conducted to identify, analyze and categorize the applications, views and tables according to the GMP impact.
- The life cycle documentation was updated for the ERP system and fully developed for the new hosting infrastructure.
- Unit and integrated tests were carried out by power users from the respective business departments.
- Legacy data were successfully migrated to the new platform during the Go Live. The validation of the migrated system in its production environment was conducted within 48 hours during the transfer.
- A GMP-compliant IT infrastructure was installed.
- An ERP system was upgraded, migrated and revalidated according to GMP.
- The companyâ€™s ERP system remained in operation throughout the project, with the sole exception of the two-day Go Live weekend.
- No historical data was lost or altered during the transfer.
- The scope of the mandate was extended to include additional reports.
- The 24-week project timetable was respected.
- The project budget was respected.