A validation practice built for regulated industries
AdvanceTechInfo is an IT and compliance consultancy providing Computer System Validation (CSV) for pharmaceutical, biotech and life sciences organisations. With expertise in GAMP 5, 21 CFR Part 11 and EU Annex 11, we help clients stay audit-ready.
We started with a single observation: most validation findings are documentation findings. Regulated companies rarely lack capable systems — they lack the evidence trail that proves those systems behave as intended, every time. Our practice was built to close that gap, working alongside quality, IT and engineering teams to produce validation packages that stand on their own during an inspection.
Today we support process control, laboratory and enterprise systems across sites in India, from initial GxP assessment through periodic review and decommissioning.
To make compliance practical — delivering risk-based validation that protects data integrity and patient safety without stalling operations.
To be the validation partner Indian life sciences companies trust when an inspection is on the calendar.
Validation of process control and automation systems on the shop floor, from GxP assessment through IQ/OQ and ongoing periodic review.
Qualification and validation of laboratory instruments and chromatography data systems, with audit trail and data integrity controls.
Gap assessments, audit support and remediation planning that keep electronic records defensible during regulatory inspections.
GAMP 5, 21 CFR Part 11 and EU Annex 11 are the regulatory frameworks our team works to. ISO 9001:2015 is shown here as a quality management framework reference — the certification badge will be published once the certificate is issued and verified.
Get a Free Consultation
Tell us about your systems. We will map them to GAMP 5 and outline the path to an audit-ready state — at no cost.