FDA Regulated Pharmaceutical Company

An FDA-regulated biopharmaceutical company, pursuing innovative solutions to improve the lives of patients living with diabetes and obesity, implemented Oracle EnterpriseOne software at both its main headquarters and manufacturing plant.

The Challenge

To ensure complete compliance with FDA auditors, the company implemented EnterpriseOne using specific processes for its main headquarters and manufacturing facility as a guideline. The manufacturing processes included implementing a Warehouse Execution System (WES) that interfaced with EnterpriseOne. This interface was subject to the same stringent requirements of EnterpriseOne. Each core team needed EnterpriseOne's integrated system to meet the integrated process requirements that the two sites shared.

To further meet FDA requirements, the company established detailed requirements that identified every task to be tested documented, validated, and approved that was configured in the system. Once the core teams approved the requirements list, they identified those deemed critical, and set out to meet specific FDA requirements.

The company sought a diversified consulting company that could provide the following documentation for the critical requirements tied to EnterpriseOne and WES:

  • Validation plans
  • Installation, Operation, and Production protocols
  • Further assistance with the Requirements Trace Matrix
  • Summary Report
  • Training Documentation

All documentation had to meet the critical requirements of both the company headquarters and manufacturing facility. Producing such documentation required a consulting firm with diversified skill sets, and someone who had the ability to produce required documentation for the main headquarters first, and then for the manufacturing facility. The company needed consultants available to craft, test, and document critical requirements at both sites, work with both core teams, and rapidly learn and understand business processes for each site.

In addition, the company needed help with training at the manufacturing facility with the EnterpriseOne/WES interface. This required using a set of customized documentation and data that core team members previously had crafted and tested.

The Solution

The company chose Intelligo not only for its knowledge of EnterpriseOne Financial, Distribution, and Manufacturing modules, but also its ability to adapt the company's business processes to each group of modules.

Assessment and Planning

Working first at the company headquarters location, we helped identify the critical requirements, and then crafted a Validation Plan that addressed all documentation needs. Once validated and approved, the Validation Plan was enacted. Intelligo scripted scenario tests that were covered in system installation, operation, and production protocols. These protocols, once validated and approved, addressed every critical task needed to meet FDA system implementation requirements.

Intelligo led the execution testing of each protocol, addressed and resolved issues from testing, and routed the test results for validation and final approval. We then crafted a summary report subject to the same validation and approval process. The Requirements Trace Matrix, Validation Plan, Protocols, and Summary Report became the deliverables to the Document Control group, who cataloged all information for future FDA audits.

Training Development

To meet the training needs of the manufacturing plant, Intelligo worked with EnterpriseOne business analysts to produce a customized set of work instructions using the company template. Intelligo would use existing documentation, but would craft additional documentation for tasks not previously identified.

Intelligo's Value-Add

Intelligo provided an organized way to meet every FDA requirement tied to the EnterpriseOne/WES system implementation. We provided critical documentation in every step of the system implementation process, and satisfied the core teams at the headquarters and manufacturing plant locations. The satisfaction extended to the Manufacturing facility, whose employees required training to understand the EnterpriseOne/WES interface process. Intelligo co-trained with company business analysts to meet these needs.

Intelligo demonstrated versatility in assisting with the following:

  • Assisting with the Requirements Trace Matrix
  • Planning with a Validation Plan as its tool
  • Scripting each critical requirement in all types of protocol documents
  • Summarizing all accomplishments in a summary report
  • Assisting with training. Intelligo left behind a complete set of documentation that survived a thorough approval process.

We met the expectations of both core teams, manufacturing facility trainees, and the FDA.