What have we done
Development of control systems according to GAMP standards defined by FDA.

Policy enforcement CFR21 part 11 of the FDA to ensure the reliability of our systems in the signatures and electronic data records.

Extensive experience in developing batch applications by following the standard ISA S88.01.

Development of projects under ISA S95 standard, which defines the plant model to facilitate the integration of production control systems (MES) with plant management (ERP).

Experience in preparing the documentation required in this kind of industry. Preparation and drafting of specifications and qualification and validation protocols during commissioning. Final delivery of completed documentation to the client.

Assistance for validation processes of facilities, even automated by  other vendors.







Johnson & Johnson

Sandoz IP (Barcelona, Spain)
Fully automated production plant for semi-synthetic erythromycin (SSE).

System based on a combination of Rockwell PLCs and DCS system with Batch DeltaV  from Emerson.
Alcon (Barcelona, Spain)
Climate control (temperature, humidity and pressure) and particle counters in Clean Rooms.

Control of water rings PW (Purified Water) and WFI (Water For Injection) and management of their points of usage.

Control of SIP and CIP (Cleaning In Place and Sanitization In Place). Reporting system and historical logging (iHistorian).

Developed with Schneider Electric PLCs and SCADA iFix (General Electric).
Biochemie (Barcelona)
Control of climate and production equipment for semi-synthetic penicillins (centrifuges, dryers, packing, etc.).

Control system with PLC and SCADA Rockwell Automation.

Specific applications using a database.
Sandoz IP (Barcelona, Spain)
Assistance to the facilities validation process .

Development of quality plans (FDA Quality Plan). Development and implementation of FDA testing protocols: DQ (Design Qualification), IQ (Installation Qualification) and OQ (Operational Qualification).