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Data Integrity Remediation Plan for Pharmaceutical Manufacturer

 

INDUSTRY

Pharmaceutical

SERVICES

Remediation

SKILLS

ISO Compliance
Four consultants with niche expertise provided over four years.

The Challenge

A global pharmaceutical manufacturer needed a team of consultants to support their Data Integrity requirements within the global standard and subordinate corporate IT compliance SOPs. The project scope included the remediation of systems against all applicable DI requirements. However, the client was facing difficulty finding the right talent for the job. Prior to partnering with Oxford Global Resources, they had worked with three different teams that were not the appropriate fit — it was difficult to find the resources with a clear understanding of the niche skill set the client was seeking.

The Solution

Over the course of four years, we were able to quickly provide four resources with expertise in QA and CSV to support the client’s initiatives. Each consultant provided was extremely flexible and adaptable to meet the needs of the client. Deliverables included:

  • Analysis of the program to assess Data Integrity related updates to specifications, validation plans, traceability matrices, and more
  • Inventory of in-scope and out-of-scope activities across data, applications, and ‘work’
  • Proactive project risk report to product quality or safety, compliance, business-related risk, and system-related risk
  • Program build to include DI remediation for major, critical GMP data both electronically and on paper
  • Local management of systems with minimum DI requirements
  • Confirmation of use of enterprise and multi-site systems
  • Risk-based approach to assess IT/Technical capabilities

The detailed task and timeline list was frequently updated on time according to our risk-based approach. Tasks included:

  • System Registry
  • Data Criticality Assessment
  • Local use of Computerized Systems
  • SOP Revisions
  • System Registry
  • Automation Equipment Remediation
  • SAP
  • QMS
  • Trackwise

Oxford consultants also executed a communication strategy, validation strategy, document impact strategy, and project closure.

The Result

By consistently supporting the client’s needs throughout varying changes in timelines and expectations, and providing talent quickly, the Oxford Consultants were able to partner with the client and achieve the necessary deliverables. To date, one Oxford consultant remains on board with this client to assist with ongoing remediation activities. Due to the efforts of our consultants, the FDA inspections came back with no observations.