Electronic batch records
Build EBRs with version control, required fields and step-by-step instructions that reflect your approved procedures.
Regulated manufacturing automation
Trace every batch. Validate every step.
Morgan & Meredith builds compliance-focused automation for Welsh food, pharmaceutical, medical device, biotechnology and chemical manufacturers. Your SOPs stay in control while records become easier to inspect.
Built around auditability, data integrity and the systems you already use.
Quality records that stand up to review.
Clear ownership, timestamps and controlled changes.
MHRARegulatory reporting
ISO 9001Quality management
ISO 13485Medical devices
GAMP 5Risk-based validation
Control without extra paperwork
Compliance-first automation features
Paper records and disconnected spreadsheets hide small changes until an audit exposes them. A controlled digital workflow gives each action a clear owner and a useful history.
Quality checks and deviations
Route failed checks and non-conformances to the right quality owner. Keep investigation notes beside the original event.
Batch genealogy
Follow raw materials, lots, operators and finished goods through each production stage. Recall decisions take minutes to prepare.
Complete audit trails
Capture user identity, timestamps, old values and new values when records change. Review the reason, not just the result.
Electronic signatures
Apply role-based approvals and electronic signatures at the points your SOPs require, with clear responsibility for every release.
Regulatory reporting
Turn controlled production data into reports for internal quality reviews, MHRA requests and FSA-related records.
Validated process automation UK
A measured implementation path
Validation starts with your intended use. We document the decisions, test the controls and prepare your teams for daily use.
Discuss your validation planRisk-based validation approach
We map the system's impact on product quality and patient or consumer safety, using GAMP 5 principles to set sensible controls.
User requirements specification
Your URS records what production, quality and technical teams need the system to do before configuration begins.
IQ, OQ and PQ documentation
Installation, operational and performance qualification evidence gives your quality team a traceable basis for approval.
Change control and revalidation
Changes are assessed before release. The validation record stays current as processes, integrations and users evolve.
Training for quality and production
Operators learn the screens they use, while administrators and quality leads learn how to review records and manage approvals.
A practical result
Pharmaceutical packager achieves full batch genealogy
Manual records had made recall preparation slow and uncertain. The new electronic batch record connected production events with material and finished-goods data.
The challenge. Paper batch records were checked in separate folders, so the quality team spent hours locating the right material and approval history during a recall exercise.
The solution. An electronic batch record system captured each process step, linked component lots and recorded approvals as work progressed. It connected with the packager's existing ERP rather than forcing a replacement.
The result. Quality staff could trace a finished batch back through its material genealogy and produce a focused recall view in minutes.
"We can see who approved each step and where every lot went. The review is calmer because the evidence is in one place."Qubra Sefuentes, Quality Manager
100%
batch genealogy recorded
Minutes
to prepare a recall view
1
controlled audit history
ERP
kept in the operating model
Clear answers for quality teams
Regulatory automation questions
Good automation should fit your quality system. These are the questions we address before any build starts.
Can the software be validated to our internal SOPs?
Yes. We begin with your approved procedures, user requirements and risk assessment. The resulting workflows, tests and approval records are documented against the way your site operates.
Do you help with MHRA submissions?
We prepare structured records and reporting outputs that support your regulatory work. Your qualified quality and regulatory teams remain responsible for submission content and final decisions.
How do electronic signatures work?
Users sign with controlled credentials at defined approval points. The audit trail records the signer, date, time, action and related record so the approval can be reviewed later.
Can you integrate with our existing LIMS?
Yes. We assess your LIMS, ERP, PLM and shop-floor interfaces before deciding where data should be created, checked and transferred. The integration design follows your validation and access requirements.
What about data integrity and ALCOA+?
We design for attributable, legible, contemporaneous, original and accurate records, with complete, consistent, enduring and available supporting evidence. Controls are mapped to your risk assessment and SOPs.
Support for Welsh manufacturers
Stay compliant. Keep production moving.
Bring us one workflow, audit concern or traceability gap. We will map the current process and identify a controlled next step with no disruption to your current quality processes.
Book a compliance automation review