Pharma & Life Sciences
GxP-aware control and data integrity for regulated production.
- Scope
- Ground to Cloud
- Approach
- Retrofit first
- Base
- Bangalore, India
The brief
What this sector asks of a control system
In regulated production the record matters as much as the process. We engineer control systems with audit trails, access control, and electronic records designed for GxP expectations — with validation documentation prepared alongside the build rather than reconstructed afterwards.
Every engagement starts the same way: we walk the floor, read the existing drawings, and write down what is actually installed before anyone proposes a platform. The sector decides the priorities — the plant decides the design.
Constraints we engineer around
What we bring
Disciplines we lead with in pharma & life sciences
The same engineering team carries the work from the panel to the dashboard, so nothing is lost at a handover between vendors.
In detail
What shapes the work here
The constraints that decide how a system for this sector gets engineered.
The record is part of the product
In regulated production, a batch you cannot evidence is a batch you cannot ship. Control systems here carry audit trails, user attribution and electronic records as first-class requirements rather than features added at the end.
That changes the build sequence. Specification and validation documentation are produced alongside the engineering, because reconstructing them afterwards is both expensive and unconvincing to an auditor.
Access control that means something
Shared logins make an audit trail worthless — if everyone is “operator”, nothing is attributable. Individual accounts, role-based permissions and enforced re-authentication for critical actions are what make the record defensible.
This is usually the least popular change on the floor and the one auditors examine first, so it is worth agreeing early rather than at qualification.
Change control after go-live
A validated system is not frozen, but changes to it follow a documented route: assessment, approval, testing, and a record of what changed and why. Ad-hoc edits to a validated program are how sites lose their qualified status.
We hand over with that process defined, so your team can maintain the system without putting its validation at risk.
Typical scope
What we are brought in to do
- Control systems engineered to GxP data-integrity expectations
- Audit trails and role-based access with individual attribution
- Electronic batch records and recipe management
- Environmental monitoring with alarm and excursion reporting
- Validation documentation prepared alongside the build
Engineering constraints
- Data integrity
- Attributable, legible, contemporaneous
- Validation
- Documented alongside the build
- Change control
- Defined route after go-live
Common questions
- Are you a certified validation provider?
- We are not a certifying body and do not claim any regulatory approval. We engineer to the data-integrity and documentation expectations your quality team works to, and produce the records they need for their own validation process.
- Can our existing system be brought up to standard?
- Often, though it depends on the platform. Systems without individual user accounts or a tamper-evident audit trail sometimes cannot be retrofitted, and replacing the layer is cheaper than arguing the case.
- Who owns the validation documentation?
- You do. It is handed over with the system, because your quality team will be the ones defending it.
Elsewhere
