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Data integrity and ALCOA+ in the laboratory
Gap analyses, audit trail review and data governance for attributable lab results.
Data integrity underpins release and inspections. LBP turns ALCOA+ into workable processes — from hybrid (paper and electronic) labs to LIMS, ELN and CDS — in line with EU GMP Annex 11 and FDA 21 CFR Part 11.
- Gap analysis against ALCOA+ and GxP requirements
- Design or sharpen audit trail review
- Roles, access and segregation of duties
- Remediation and training
Related services: AI & smart systems, CSV/CSA and Stay validated.
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Email us or call +31 6 40 90 78 31 — you will get a personal reply within two working days.