Trust the data your systems produce.
Regulated data is only as reliable as the systems that create it. We deliver GAMP 5 and 21 CFR Part 11 compliance across MES, LIMS, ERP, DCS, SCADA, and laboratory systems, proving that your electronic records and signatures are attributable, accurate, and inspection-ready.
GAMP 5 and 21 CFR Part 11 compliance for MES, LIMS, ERP, DCS, SCADA, and lab systems.
What we deliver, in depth.
GAMP 5 Validation
Risk- and category-based validation scaled to system complexity and impact.
21 CFR Part 11
Electronic records and signatures assessed for attributability and data integrity.
MES & SCADA / DCS
Manufacturing execution and process control validated to production reality.
LIMS & Lab Systems
Laboratory informatics validated for accurate, traceable results.
ERP
Enterprise systems assessed where GMP-relevant data lives.
How we take it from scope to certified.
Classify
Categorize systems by GAMP risk and GMP impact to right-size effort.
Specify
Define requirements and functions with testable acceptance criteria.
Verify
Execute risk-based testing with reviewed, contemporaneous evidence.
Maintain
Establish periodic review to keep systems in a validated state.
Deliverables and the benefits behind them.
What you receive
- Validation and risk assessment plans
- Requirements and functional specifications
- IQ / OQ / PQ test scripts and evidence
- Data integrity (ALCOA+) assessments
- Traceability matrices and validation summary reports
Why it matters
Data integrity built in
Records that are attributable, legible, contemporaneous, original, and accurate.
Right-sized effort
Risk-based scoping means you validate what matters, faster.
Audit confidence
Complete traceability from requirement to executed evidence.
Related services.
Ready to scope your computer system validation work?
Contact us today for a complimentary scope discussion and project assessment with one of our founding consultants.