Sector
Pharmaceutical IT consulting: GMP, production, data
Lunova supports pharmaceutical companies with their information systems, from PLC to enterprise software: computerised system validation, IT governance, supplier management and infrastructure projects, up to the IT of a new production site.
Lunova advises and leads: it does not develop, integrate or resell.
The sector
Our pharmaceutical expertise
In a pharmaceutical company, the information system does not stop at the office. It reaches down to the shop floor: PLCs, equipment control interfaces, the historian that records production data, laboratory software. This data must remain accurate, traceable and available, and every change must leave a reviewable record: the audit trail. Good manufacturing practice, and its annex on computerised systems, therefore adds to the operational constraints: production that cannot stop, research data to protect, and many suppliers who need to move forward together.
Lunova currently supports a fast-growing pharmaceutical company, working alongside its IT manager. The role is cross-functional: bringing the information system and its governance up to current standards, computerised system validation, supplier management and project delivery, including the IT side of building a new production site.
Situations
The situations that lead a pharmaceutical company to call us
You may recognise one of these situations.
A new production site is being built, and IT must be ready on day one. Network, separation between business IT and production equipment, redundancy, disaster recovery plan, cloud or on-premises: these decisions are made during construction, not after.
Production equipment arrives, each with its own PLCs and supervisory stations. It comes from different manufacturers and must be connected without exposing production. Its data must also reach the historian intact, and the audit trail must be active and used.
An inspection or quality audit is approaching, and computerised systems are in scope. Who has access to what, how data is backed up, how a system was validated before go-live: you need to be able to show it, with documents to back it up.
The company is growing faster than its IT organisation. The IT manager handles day-to-day operations, suppliers and projects, and governance now needs to be structured to keep pace with growth.
Depending on your starting point, the answer lies in an audit of your information system to get an objective view of the situation, or in project leadershipto keep a project already under way on track.
Lunova works from Nyon across the Lake Geneva region and Western Switzerland.
Before you decide
Frequently asked questions about pharmaceutical IT
Do all IT systems on a pharmaceutical site need to be validated?
No. The validation effort is proportionate to the system’s impact on product quality and data integrity. The first step is to inventory the systems and assess their criticality: this classification determines what needs to be validated and in how much detail. This work is carried out with the quality manager, who remains the decision-maker.
What is the audit trail of a production system for?
It is the log, kept by the system itself, that records who created, modified or deleted a piece of data, when and why. It shows that production or laboratory data has not been altered. It must be enabled, protected against any modification and reviewed regularly: it is one of the points that system validation checks.
How do you prepare the IT of a new production site?
By building it into the construction project from the design stage. The network, the separation between business IT and production IT, redundancy and the disaster recovery plan are decided during the design studies, while the options are still open. Lunova handles this workstream alongside the project team and suppliers, through the steering committee.
Our IT manager is on their own as the company grows: what can we do?
External support can take on what goes beyond day-to-day operations, such as governance, supplier management, projects or system validation. The IT manager keeps control of their scope and relies on support for the rest.