Abstract Layer: MediSync

Compliance,
checked before
the inspection.

MediSync is one AI engine that checks whether your documentation complies with regulatory requirements, and shows exactly where the gaps are. Two versions, one engine: Enterprise for manufacturers, One for pharmacies.

Ingest the documents.
Map them against the rules.
Flag where the two don't match.

MediSync is a single technical core (AI mapping of document against rule) pointed at two markets. The same engine that checks a manufacturer's validation records against GMP and EU MDR also checks a pharmacy's mandatory registers against Croatian regulation. Built once, deployed where the regulatory risk is highest.

What differs between the two products is the customer, the regulatory framework, and the depth, not the idea. In both cases, the point is the same: find the gaps before they become a penalty.

MediSync
Enterprise
A product by Abstract Layer Regulatory compliance for manufacturers · GMP & EU MDR

Right now, compliance checking is done by hand: quality-assurance and regulatory experts read hundreds of pages of documentation to confirm everything lines up with the rules. It is slow, expensive, and error-prone, and a single miss found in an audit can mean a halted production line, a recalled batch, or a lost certificate.

MediSync Enterprise takes your internal documents (validation records, SOPs, batch records) together with the relevant regulatory requirements, and produces a compliance matrix: what is covered, what is missing, and where there are contradictions. Instead of weeks of manual reading, you get a prioritized gap report in hours.

Request a Demo How it works
Hours
Not weeks of manual review
GMP + MDR
Requirements mapped to your docs
HR
Croatian & domain terminology
Document × Requirement Mapping

Each regulatory requirement is linked to the specific place it is addressed in your documentation, automatically, across hundreds of pages.

Compliance Matrix

A clear grid of what is covered, what is missing, and where two documents contradict each other, so nothing hides in the gaps between them.

Prioritized Gap Report

A ranked list of what to fix first, ready before your next audit or inspection, turning weeks of review into a working document you can act on today.

Built for Regulated Environments

A retrieval pipeline that works over your own documents: domain mapping of internal document against GMP and MDR, not a broad, generic compliance framework.

Load your documents

Validation records, SOPs, batch records, and the relevant regulatory frameworks (GMP, EU MDR) go into MediSync.

AI maps compliance

Every requirement is matched against your documentation. Gaps and contradictions are flagged as they are found.

You get the report

A clear overview of what is missing and what to prioritize, ready before the audit or inspection.

For quality-assurance & regulatory-affairs teams
Pharmaceutical manufacturers Medical-device manufacturers GMP EU MDR Validation & SOP review Subscription + per-site implementation
MediSync
One
A product by Abstract Layer Inspection-readiness for pharmacies · HZZO

Croatian pharmacies are legally required to keep a series of mandatory records: the narcotics register, prescription copies, the expiry-dates book, medicine-consumption records. HZZO inspects by direct review of this documentation, and when it finds irregularities the consequences are concrete: warnings, damage compensation, and deductions from invoice payments.

MediSync One passes through your records and dispensing data, detects gaps, expired items, and inconsistencies, and gives you a clear "inspection-readiness" report: what to fix before the inspector arrives, not after the penalty lands.

Request a Demo What it checks
HZZO
Ready before the inspector arrives
4+
Mandatory registers checked
0
Double entry: a checking layer, not a book
Record Checks

Detects gaps, expired deadlines, and inconsistencies across the mandatory registers your pharmacy is required to keep.

Dispensing Checks

Confirms that medicines dispensed against prescriptions match what was prescribed (price, quantity, ATC classification), the kinds of errors HZZO penalizes.

Inspection-Readiness Report

A plain report of what is missing and what to correct, before the inspector arrives, so preparation stops being manual and stressful.

A Layer, Not a Replacement

Your existing pharmacy software already keeps these records. MediSync One is a checking layer on top: it never logs anything twice, and stays away from temperature and humidity monitoring.

What it checks

The records HZZO reviews.

Narcotics register (knjiga prometa droga)
Prescription copies (kopije recepata)
Expiry-dates book (knjiga rokova)
Medicine-consumption records
Dispensed vs. prescribed: price & quantity
ATC classification consistency
Expired items & missing entries
Overall inspection-readiness summary
Complementary to your existing setup
Existing pharmacy software Prescription & dispensing systems HZZO reporting Independent & group pharmacies Environmental monitoring, left untouched Subscription per pharmacy
A checking layer, not another book

MediSync One does not record anything a second time. It sits on top of what your systems already keep and surfaces errors and risk before they turn into a penalty.

Before the penalty, not after

The pain is regulatory and mandatory, with a direct financial consequence. MediSync One turns preparation from a stressful, manual scramble into a report you can act on ahead of time.

Built for Croatian regulation

Mandatory registers, HZZO review, and the specific errors that get penalized: MediSync One is built around the rules your pharmacy actually operates under, in Croatian.

Complementary, not competitive

It deliberately stays away from temperature, humidity, and monitoring, so it does not compete with your existing tools, it completes them.

About Abstract Layer

Build the engine once.
Sell it twice.

Abstract Layer builds MediSync, a single AI engine that ingests documents, maps them against a set of regulatory rules, and flags where the two don't match. The strategic logic is simple: one technical core, pointed at two markets that both feel regulatory risk acutely.

A small number of deep-pocketed manufacturers on one side; a large number of small, quick-deciding pharmacies on the other. The brand link is deliberate and the technology is shared, but each product speaks the language of its own buyer.

Domain-specific, not generic

Mapping of internal document against specific regulatory requirement (GMP, EU MDR, HZZO), not a broad, one-size compliance framework.

Works in Croatian

Built to handle Croatian regulation and domain-specific pharmaceutical and validation terminology, where generic tools fall short.

For regulated environments

A precision level you can rely on where the cost of a miss is measured in halted lines, recalled batches, and penalties.

Tim tvrtke Abstract Layer pregledava regulatornu dokumentaciju o usklađenosti
Security & Data

Your documents
stay yours.

MediSync is built for a regulated environment, which means your documentation is handled accordingly. Data residency, encryption, and access control are designed in, and your documents are used to check your compliance, not to train anyone else's models.

Deployment
Cloud or On-Premise
Data Residency
EU / Croatia
Encryption
AES-256 at Rest & In Transit
Access
Role-Based, Full Audit Trail
Your Documents
Never Used to Train External Models
Compliance
GDPR

A support tool, not a verdict

MediSync supports your compliance checking. It does not replace official regulatory assessment or the user's own responsibility for compliance, it makes the work faster and the gaps visible.

Guided implementation

Enterprise deploys per site alongside your QA and regulatory teams; One deploys quickly per pharmacy. In both cases, setup is guided, not left to you.

Croatian, end to end

The product, the terminology, and the support all work in Croatian and around Croatian regulation, because that is where the compliance actually happens.

Frequently Asked

Questions, answered.

How does MediSync connect with our existing systems?

You provide the documents and records to be checked. MediSync works over your own documentation and sits alongside the systems you already use: it is a checking layer, not a replacement for them.

Where is our data stored and how is security handled?

Data can be kept within the EU / Croatia, encrypted at rest and in transit, with role-based access and a full audit trail. Your documents are used to check your compliance, never to train external models. On-premise deployment is available where required.

How long does implementation take?

MediSync One is designed for fast, per-pharmacy rollout. MediSync Enterprise is implemented per site alongside your QA and regulatory teams, scoped to your documentation and frameworks.

Does it support Croatian regulations and terminology?

Yes. MediSync is built specifically to work in Croatian and with domain-specific pharmaceutical, validation, and pharmacy terminology, mapped against the relevant Croatian and EU regulatory requirements.

Get in Touch

Reduce risk and
review time.

Tell us whether you are a manufacturer or a pharmacy, and we will show you what MediSync flags on real documentation and how a deployment would work for you.

Headquarters Cvite Fiskovića 4
21000 Split, Croatia