SERVICES

Senior-level execution for critical GMP work.

Flexible, experienced support across commissioning, qualification, validation, compliance, and project execution. Scaled to the work, not a generic consulting model.

Support can begin with one stalled deliverable or extend across an entire project stream.

Each engagement starts with a clear objective, defined ownership, and practical deliverables. Keystone integrates with engineering, quality, operations, manufacturing, automation, vendors, and project teams to move forward without adding unnecessary layers.

The emphasis is not on producing more consulting activity. It is on producing reliable, inspection-ready outcomes.

01

CQV Strategy & Execution

Structured support from planning through turnover, with field execution under the client’s site governance and engineering oversight.

  • Validation & CQV Planning

  • URS & Traceability

  • IQ/OQ/PQ protocol development

  • Discrepancy & Deviation Resolution

  • Risk assessments & criticality

  • FAT/SAT & turnover review

  • Field execution support

  • Summary reports & closure

02

Validation Lifecycle Support

Practical lifecycle documentation and execution aligned to product, process, equipment, utilities, facilities, and computerized systems.

  • Process validation

  • Equipment qualification

  • Periodic review

  • Traceability matrix development

  • Cleaning validation

  • CSV & Part 11 support

  • Change control impact assessment

  • Lifecycle documentation remediation

03

Project & Workstream Execution

Hands-on ownership when complex capital, operational readiness, or compliance work needs stronger coordination and follow-through.

  • Integrated project planning

  • Cross-functional governance

  • Risk & issue management

  • Decision & action management

  • Milestone & schedule recovery

  • Vendor & OEM coordination

  • Readiness tracking

  • Executive status reporting

04

Compliance & Remediation

Targeted support to resolve findings, strengthen documentation, reduce recurring execution failures, and improve inspection readiness.

  • Gap assessments

  • Deviation backing support

  • Data integrity remediation

  • Documentation quality review

  • CAPA planning & execution

  • Audit & inspection readiness

  • Procedure improvement

  • Sustainable handoff to site teams

ENGAGEMENT MODELS

Right-sized to the problem.

No oversized team, forced methodology, or artificial consulting layer.

FOCUSED

Define Deliverable

A specific protocol package, assessment, remediation plan, validation document, or closure activity.

EMBEDDED

Workstream Leadership

Temporary ownership of a critical project, validation stream, readiness program, or compliance initiative

FRACTIONAL

Senior Advisory Support

Flexible senior-level guidance and oversight when internal leadership needs additional depth or bandwidth

Need experienced ownership on a project that cannot keep slipping?

DISCUSS THE WORK