Industries
Technology work in a validated environment
In a GxP environment, the change itself is only part of the job. The evidence that the change was specified, tested and approved is the other part, and it has to exist before the system is used.
What makes this sector different
Validation changes the shape of a project. Requirements are written to be testable, specifications are approved before build, test scripts are executed with evidence, and deviations are recorded and closed. Teams that have not worked this way underestimate it by a wide margin, which is the most common reason a life sciences project slips.
Data integrity principles apply to the systems and to the people using them. Audit trails must be on and reviewable, records must be attributable, and changes to master data need the same control as changes to code.
Supply chain systems carry regulatory duties of their own. Serialization and traceability requirements under the Drug Supply Chain Security Act reach into SAP, warehouse systems and the interfaces between them.
Where the work usually is
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Validation effort underestimated
Specifications, test scripts, execution evidence and approvals take real time. Planning them late is how dates slip.
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Legacy validated systems
Systems that cannot be patched quickly because revalidation is required. The answer is usually compensating controls plus a planned upgrade.
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Audit trail gaps
Audit trails switched off for performance, or never reviewed. Both come up in inspections.
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Serialization interfaces
Data exchange with contract manufacturers and distributors, where a format change breaks a line.
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Lab system integration
LIMS and instrument data moved by spreadsheet. Error-prone and hard to defend.
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Master data control
Material, batch and recipe data changed without the same rigor as configuration changes.
Systems and platforms we work in
Platform names describe where our consultants have worked. They do not imply a vendor partnership or certification.
How we help
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SAP implementation and conversion
Functional and technical consultants for process manufacturing, quality and warehouse scope.
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Validation support
Specifications, traceability matrices, test script authoring and execution support.
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Integration development
Interfaces between ERP, lab, quality and partner systems, with documented mappings.
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Data migration
Material, batch and historical data with cleansing, rehearsals and reconciliation.
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Security assessment
Testing and configuration review for systems where patching is constrained.
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Specialist staffing
SAP PP-PI, QM and EWM consultants, validation engineers, CSV analysts and data migration leads.
Regulatory and contractual context
- FDA 21 CFR Part 11 sets expectations for electronic records and electronic signatures in regulated systems.
- EU Annex 11 covers computerized systems for medicinal products in the European Union.
- GAMP 5 second edition is the common industry reference for a risk-based approach to computerized system validation.
- The Drug Supply Chain Security Act drives serialization, traceability and data exchange requirements across the supply chain.
- Data integrity guidance from FDA and MHRA shapes audit trail, attributability and review requirements.
- Quality agreements with contract manufacturers affect what data is exchanged and how changes are approved.
Roles we recruit for this sector
Contract, contract-to-hire and direct hire. We do not sponsor visas: candidates must already be authorized to work in the United States.
Illustrative engagement
Illustrative scenario. Not a real client engagement. No outcomes are claimed.
A mid-sized pharmaceutical manufacturer is converting ECC to S/4HANA and must keep its validated scope defensible through the conversion.
- Starting point
- ECC with process manufacturing, quality and warehouse scope, a large body of custom code and a validation package built over a decade.
- Scope
- Conversion planning with a validation strategy agreed with quality: impact assessment, requalification scope, test scripts and evidence capture built into each phase.
- Team
- A conversion lead, PP-PI and QM consultants, Basis and ABAP engineers for custom code, a CSV analyst and a test lead.
- Evidence
- Impact assessment approved by quality, a traceability matrix from requirement to test, executed scripts with evidence, and a deviation log closed before go-live.
- What is not claimed
- An illustration of how the work is scoped. Not a client project, and no outcomes are implied.
Questions people ask
Can you own validation for us?
We can author and execute validation documentation and support your quality process. Approval of validation remains with your quality unit, and we do not act as the regulated company’s quality function.
Do your consultants have GxP experience?
For life sciences roles we screen specifically for it, and we tell you which regulated projects a consultant has worked on rather than presenting general ERP experience as equivalent.
How do you handle patching on validated systems?
We assess the risk, propose compensating controls where a patch cannot be applied quickly, and plan the upgrade with the revalidation work costed in. We do not recommend leaving a known exploited vulnerability in place without a control.
Can offshore staff work on a GxP project?
Only under terms you agree in writing, and usually limited to roles with no access to regulated production systems or data.
Related
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SAP
S/4HANA implementation and migration, Finance and Supply Chain modules, Fiori, BTP and integration, plus the architects, functional consultants, developers and Basis engineers who do the work.
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Data migration
Plan, extract, cleanse, map, load and reconcile data between systems, with business owners signing off every object.
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Quality engineering
Test strategy, automation, performance and reliability engineering built into the pipeline.
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Manufacturing
Planning, shop-floor integration, quality, maintenance and warehouse flows.
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