OPSISTECH

Pharmaceutical production sits inside one of the most heavily regulated quality frameworks in industry. Every machine that touches the product, every operator who interacts with it, and every record generated about it must be qualified, validated, and retained — often for decades. A defect that escapes the line is not just a quality event; it is a patient-safety event with criminal liability attached.

Machine vision is the inspection technology that scales to the volumes of modern pharma — millions of tablets, vials, and blister pockets per shift — while producing the per-unit electronic record that 21 CFR Part 11 and EU GMP Annex 11 demand. Each pocket is verified, each label decoded, each serialised code grade-checked, each result archived with image evidence.

Opsistech delivers vision systems with the full GMP validation lifecycle — URS, DQ, IQ, OQ, PQ — together with traceability matrices, FAT/SAT, and the change control framework needed to keep the system qualified through its operating life. Compliance is not an add-on. It is built into the specification.

A vision system in a pharmaceutical plant is not just an inspection device — it is part of the validated state of the manufacturing process. That means it must be specified against a User Requirement Specification, qualified through Installation, Operational, and Performance Qualification, and operated under change control for as long as the product it inspects is on the market. Opsistech delivers each of those steps as part of the standard project — not as a paid extra.

Software is engineered against 21 CFR Part 11 and EU GMP Annex 11 from the first commit — secure user accounts, role-based access, electronic signatures, tamper-evident audit trails, and time-synchronised event logs. Every inspection result is archived alongside the decision-time image, allowing any disposition to be reviewed years later by an inspector or a court.

Our systems integrate with the leading serialisation track-and-trace platforms — SAP ATTP, Tracelink, Antares, Optel — meeting both US DSCSA and EU FMD reporting obligations. And because qualification is only the start, we partner with you on the periodic review, change control, and re-validation cycles that keep the system in a validated state for its entire operational life.