SCADA Software for Pharmaceutical Manufacturing

Part 11 governs electronic records and electronic signatures in FDA-regulated production. It requires that records be attributable, legible, contemporaneous, original and accurate, that changes be captured in a secure audit trail, that access be controlled by authenticated individual accounts, and that electronic signatures be linked to the records they approve. In a SCADA system that means individual named accounts rather than a shared operator login, an audit trail written where the operator cannot edit it, timestamps taken from the server, retention that outlasts the record, and signatures that carry both the signer and the meaning of the signature.

Yes. Electronic signature can be required on any individual control in a display, with a configurable timeout after which the platform prompts for the password again, and the signature meaning is configured with it so the record shows reviewed by, approved by, verified by or released by. The audit trail is written to a SQL database with the user, a server-side timestamp, the message and the originating condition, and you choose which classes of event are captured, from logon and tag changes to operator actions and report saves. Authentication runs through LDAP or the platform's own directory, and role-based access control governs who can view, command and configure.

An audit trail is a secure, time-stamped record of every action that creates, modifies or deletes a regulated record, showing what changed, who changed it and when. It cannot be edited by the people it records. In practice it is what an inspector reads to establish that a batch record reflects what actually happened. The properties that make it hold up are that its timestamps come from the server rather than a workstation clock, that deletion is prevented rather than discouraged, and that it is retained at least as long as the record it describes.

Yes. Environmental monitoring systems track temperature, humidity, differential pressure and particle counts in classified areas, alarm on excursions, and hold the record for release. FrameworX supports these applications with continuous data collection, redundancy, integrated historian and configurable alarm handling, and derived statistics such as mean kinetic temperature are built as custom calculations and historised alongside the measured values. Hikma Pharmaceuticals uses it for sterile environmental monitoring, replacing a chart recorder system with electronic records.

Two mechanisms cover two different failures. For a server failure, redundancy is available as a licensed option: in a hot-standby pair the standby holds the solution loaded with its modules paused and synchronised from the active server, and takes over automatically in about a second without operator intervention and without custom engineering. For a storage or network interruption, the historian's Store and Forward buffers readings locally and writes them through when the destination is reachable again, so the archive is continuous rather than carrying a gap. For a regulated plant the gap is the whole problem, because environmental data with a hole in it does not support a release.

Not necessarily. Validation scope depends on which functions change and on how the system is qualified, so a phased migration that leaves the process control layer intact typically has narrower validation impact than replacing everything at once. FrameworX supports that shape of project directly: Execution Profiles hold separate Development, Validation and Production environments in one project so new work is built and tested without touching the qualified environment, and control stays in the PLCs while the supervisory layer is replaced area by area. The scope still has to be assessed against the specific installation and its existing qualification.

As an audited control action. FrameworX 10.1.5 adds a dedicated audit category for AI-driven actions: when an external AI client invokes a Custom Tool written by the solution author, the platform emits an audit row carrying the tool name, the full arguments, the caller chain, the connected user and the result status. Read-only queries are not logged, because reading a value is not a regulated control action, while executing a Custom Tool is, under 11.10(e). The audit is on by default. The AI client does not receive open access to the tag database: it can invoke only the tools the solution author deliberately wrote and only what the connected user's role permits.

No, and no SCADA platform is. There is no FDA approval or certification for a software product of this kind. Part 11 compliance is assessed for a validated computerised system in a specific plant, running a specific configuration under specific procedures, and it belongs to the plant. What a platform can provide is the technical controls the regulation asks for, the documentation showing how to configure them, and the validation documentation structure a qualification is built around. Tatsoft publishes all three, and applications built on FrameworX have been validated under 21 CFR Part 11 at solution level in production.

Yes. Equipment is modelled to the ISA-88 hierarchy, from enterprise through site, area, process cell and unit to equipment module, with a live batch and its operations carried against that structure. The reference model is imported from a standard ontology file rather than rebuilt by hand, and the namespace materialises typed objects and tags from it. A worked wet-granulation example with a mixer and a reactor under a process cell ships with FrameworX 10.1.5 and is documented publicly. The same pattern applies to ISA-95 or to a corporate asset model.

A qualification effort is normally built around a user requirements specification, a functional requirements specification, a design specification, installation, operational and performance qualification protocols, a traceability matrix, and standard operating procedures for user management, password management, audit trail review, backup and recovery, change control, electronic signature and system validation. Tatsoft publishes the configuration guide that maps each Part 11 requirement to the platform feature that carries it, together with the security hardening guides, so the traceability matrix can be built against documented behaviour. The qualification itself is executed by the plant or its integrator.