In pharmaceutical manufacturing, automation has to control the process and prove it. We build both in.
Since about 2005 we have developed the control and monitoring software for lyophilizers built by Lyophilization Systems Inc. (New York) and its Indian arm. The machines are exported to Southeast Asia, the Middle East, Europe, China and Russia, and we commissioned two systems on site in the United States. The software runs the full recipe (freezing, primary drying, secondary drying), controlling shelf temperature, chamber pressure, condenser temperature and vacuum, with every parameter and operator action recorded to 21 CFR Part 11.
User management with role-based access, electronic signatures on critical actions, audit trails that cannot be edited, secure historian storage, batch reports generated from recorded data, and documentation to support validation (URS, FDS, IQ, OQ).
The batch record writes itself. Every setpoint change and every operator action is logged with a name and time, and nobody can edit the log.
FDA, EU and CDSCO inspectors ask for the audit trail. A system without Part 11 features cannot produce one.
Three to five months including validation documentation.
Attach these to your enquiry. The three marked essential are enough for us to start a budget.
They define what is recorded, which setpoints are critical and which actions need a signature.
Validation traces back to the URS, so we need it first.
Who may change, approve and release is configured into the system, not added later.
Part 11 controls depend on the SCADA version and its security configuration.
We write to your formats so QA does not have to rewrite them.
It decides which inspectors read the audit trail and how it must be reviewed.
Audit trails and batch records must stay readable for the whole retention period.
Qualification runs on calibrated instruments only, so gaps delay OQ.
Do not have all of it? Send what you have; we work from a site visit for the rest.
Overall: Three to five months including validation documentation.
Every plant is different, so we price from the I/O list and scope rather than a rate card. Send the documents above and you will have a budget figure within a week, and a fixed price after the scope call.
A partnership running since about 2005: our control software ships inside freeze dryers exported to five regions. Two systems commissioned on site in the USA.
Recipe control of freezing, primary and secondary drying with every parameter and action logged to Part 11.
Regulated industry automation and ongoing maintenance contracts.
Reactor automation on Honeywell PLC, cleanroom HVAC on Honeywell HC900, API batch automation, and iFIX support under AMC.
Secure, time-stamped electronic records, audit trails of every change and operator action, unique logins with electronic signatures, and protection of records for their retention period.
iFIX provides electronic signatures, audit trails and secure historian data, and is widely accepted in regulated pharmaceutical plants. Our freeze dryer SCADA has been built on it for about twenty years.
Tell us what you are planning, even if the details are still rough. We reply with a technical approach and an offer.