Computer System Validation · Data Integrity · Manufacturing Systems
Kestrel Life Sciences helps pharmaceutical, biotech and medical device companies specify, build, validate and remediate the computerised systems their products depend on. We write the evidence ourselves, and we make it hold together.
Why people call us
“We have a data integrity finding to close.”
Gap assessment, a remediation plan, the technical controls, and a check that they still work afterwards.
“We are bringing in a new system and it has to be validated.”
The validation package written alongside the project, so go-live is not waiting on paperwork.
“We need one document, and we need it soon.”
A user requirements specification, validation plan, risk assessment or protocol, made to order for your system.
“Our supplier has delivered and we are not sure it is right.”
Independent review of the specification, the testing and the evidence, and oversight of the integrator until it is.
“Data is not reaching the batch record reliably.”
Interface design, OPC and historian engineering, with the data path qualified end to end.
“We are migrating and must prove nothing was lost.”
Migration strategy, reconciliation and verification evidence, and quality sign-off.
“Our quality system does not cover computerised systems.”
Policies, procedures and templates written for your organisation, ready for audit.
“Our team is spread across countries and languages, and the requirements are getting lost.”
We map the requirements through to the validation package, so everyone works from the same record.
“We are short of validation people for a project.”
Experienced people who join your team for the work, then hand it back.
Services
Every service follows the same lifecycle: understand the process, define the requirements, assess the risk, build or configure, test, and hand over evidence that stands up to inspection.
Risk-based validation across IT, automation and laboratory systems.
Findings turned into controls that still work at the next review.
Execution, control and historian systems, engineered and validated.
Interfaces between shop floor, laboratory and enterprise systems.
Quality systems written from a blank sheet, and Vault programmes led from the quality side.
Regulated records that arrive complete, unchanged and provable.
The path from instrument to record, treated as a GxP data flow.
The enterprise and infrastructure layers the shop floor depends on.
Made to order
Tell us the system and the regulation, and we produce the document or the whole package, right first time and ready for audit. Order one deliverable or a full lifecycle set. You pay for the work that is done.
We work to the ISPE GAMP guides and good practice guides, including:
A validation package is a set of documents that must agree with each other. Most of the effort, and most of the inspection findings, sit in the joins: the requirement with no test, the test that traces to nothing, the clause nobody addressed.
computersystemvalidation.io helps validation engineers draft lifecycle documents, find the gaps in an existing document set, and keep requirements, specifications and tests traceable to one another. It is a decision-support tool. It does not validate a system for you, and it does not replace the validation engineer.
URS-001User requirementApprovedRA-004Risk — highControlledFS-012Functional specificationApprovedTS-027Test scriptIn reviewURS-014User requirementGap: no testSectors
Active pharmaceutical ingredients, biologics, vaccines, sterile and oral dose, plasma products and packaging. GMP, GLP, GCP and GDP.
ISO 13485, ISO 14971, IEC 62304, EU MDR and 21 CFR Part 820, with the system integration to match.
Validation packages and quality systems for vendors supplying IT and automation into regulated manufacturers.
How we engage
A short call to agree the system, the regulation and the deliverables.
Fixed deliverables or time-based, whichever suits the work.
Remote by default, on site for workshops, walkdowns and testing.
Evidence reviewed, approved and ready for inspection.
About
We author requirements, protocols and reports, and we have sat in the reviewer's and approver's seat for change controls, CAPAs and deviations.
A base trade in network engineering means infrastructure, interfaces and applications are understood as one system.
We are used to global programmes and team members for whom English is not always the first language. This is often where we are brought in: to map the requirements, the validation packages and the evidence into one clear record.
Audit lead and audit host, supplier audits, and remediation programmes driven by regulator findings.
Insights
What the 2025 draft asks of every computerised system, and what to do before the final text lands.
Which models can be used in critical GMP applications, and the evidence needed before one goes live.
What the US rules actually say about AI, and how to build one evidence package for both sides of the Atlantic.
We will come back to you within one working day.