In Life Sciences, data integrity isn't just a best practice—it's a legal mandate. Micraft provides the digital thread required for end-to-end compliance in Pharma manufacturing.
From batch record management and serialization to cleanroom operations and instrument validation, our platform is built for the rigorous standards of GMP and cGMP. We help Pharma manufacturers transition from paper-based risk to digital-first compliance.
Pharma manufacturers operate in one of the most heavily regulated environments in the world. The requirement for ALCOA+ (Attributable, Legible, Contemporaneous, Original, Accurate) data integrity means that every touchpoint on the shop floor must be recorded with absolute precision.
However, many facilities still rely on paper batch records and manual signatures. This creates massive operational overhead and significant risk. A single transcription error can lead to a batch rejection or an FDA 483 warning letter. Serialization requirements add another layer of complexity, demanding real-time synchronization between production and packaging lines.
Micraft is built to eliminate these risks. By digitizing batch records, automating calibration alerts, and providing real-time visibility into cleanroom parameters, we ensure that compliance is a byproduct of your operations, not a separate burden.
Ensuring Data Integrity Across the Product Lifecycle.
Manual recording of batch data leads to errors, illegible entries, and delayed reviews. Compiling paper records for audits is slow and error-prone.
Micraft eBR (Electronic Batch Records) captures data at the source. Automated timestamps and digital signatures ensure ALCOA+ compliance. Real-time review by exception reduces release times from weeks to hours.
Meeting global serialization mandates requires complex integration between production lines and corporate systems. Mismatches lead to supply chain disruptions.
Integrated serialization modules track every unit from individual pack to shipper to pallet. Seamless integration with GS1 standards and global regulatory databases for end-to-end traceability.
Manual monitoring of temperature, pressure, and humidity in cleanrooms is inconsistent. Missing a parameter excursion can compromise entire batches.
Direct integration with environment sensors. Real-time alerts and automated logging of cleanroom conditions. Excursion reports generated automatically, linked directly to affected batch records.
Managing SOPs, validation protocols, and change controls in paper or simple file shares creates major compliance risks during inspections.
DoxCraft provides a 21 CFR Part 11 compliant document management system. Electronic signatures, version control, and automated approval workflows ensure you are always audit-ready.
Compliance is not an option in Pharma. Our platform is built from the ground up to support the world's most rigorous standards.
Electronic Records & Signatures
Full audit trails, secure digital signatures, and record integrity as required by US FDA.
Computerised Systems
Compliance with European guidelines for computer systems in pharmaceutical manufacturing.
Medical Device Quality
Quality management systems for the design and manufacture of medical devices.
International Standards
Supporting Good Manufacturing Practices as defined by the World Health Organization.
A unified digital layer that connects your production, quality, and documentation teams.
Instrument calibration status is verified automatically at the start of every production batch.
Completed batch records are automatically archived as tamper-proof PDFs with full audit trails in DoxCraft.
Quality release documents are linked to specific lots in the WMS, ensuring only released material can be dispatched.
Pharma manufacturing is transitioning to Industry 4.0, and the core of that transition is digital compliance. Micraft provides the specialized tools needed to manage complex life sciences operations without the overhead of massive enterprise IT projects.
Our platform is designed for the reality of cleanroom environments—cleanable hardware interfaces, biometric-ready logins, and workflows that reflect the specific order of pharmaceutical operations.
For manufacturers looking to reduce their cycle times, eliminate manual documentation risk, and achieve a state of permanent audit-readiness—Micraft is the partner of choice for Life Sciences.
