Annual Product Quality Review 
Helping operations teams unlock efficiency through automation, IoT, and AI-powered solutions.

Pharmaceutical Manufacturing Solutions

Built for pharma. Built for compliance.

Crescent Technology partners with AmpleLogic to deliver a fully integrated suite of digital systems for pharmaceutical manufacturers — purpose-built for 21 CFR Part 11 compliance, GMP readiness, and operational efficiency across the entire manufacturing lifecycle.

What pharma manufacturers deal with every day

Compliance pressure, fragmented data, and manual processes are the norm. They don't have to be.

Audit Readiness Takes Weeks

Pulling together batch records, deviation logs, and quality documentation from paper and disconnected systems takes days. An FDA inspection should not require a fire drill.

21 CFR Part 11 Compliance Gaps

Manual logs, shared logins, and paper records create audit trails that don't hold up. Electronic systems that aren't properly validated put your license at risk.

Siloed Systems Slow Everything Down

Your QMS, LIMS, MES, and training systems don't talk to each other. Data lives in silos, approvals stack up, and your team spends more time managing information than acting on it.

Our pharma solutions suite

15 purpose-built systems covering every function from production and quality to training and regulatory submissions — all designed to work together.

APQRAnnual Product Quality Review

Ensure regulatory compliance with automated Annual Product Quality Reviews, tracking product lifecycle data and quality trends.

eLogsElectronic Logbook System

Digitize and centralize logbook entries with a secure, 21 CFR Part 11-compliant Electronic Logbook System.

LIMSLaboratory Information Management System

Manage samples, workflows, and lab data efficiently with a powerful Laboratory Information Management System.

MESManufacturing Execution System

Track, control, and document the entire manufacturing process in real time with a Manufacturing Execution System.

CAPSCalibration & Preventive Maintenance

Automate equipment calibration and schedule preventive maintenance to reduce downtime and improve compliance.

RIMSRegulatory Information Management System

Streamline submission processes and manage regulatory documents with a central Regulatory Information Management System.

LMSLearning Management System

Train employees and manage certifications with an integrated Learning Management System tailored for pharma compliance.

EMSEnvironmental Monitoring System

Monitor and control environmental parameters like temperature, humidity, and pressure in real-time.

eQMSElectronic Quality Management System

Automate quality processes such as CAPA, change control, and audits with a robust Electronic Quality Management System.

UAMUser Access Management System

Manage user roles, access rights, and audit trails securely with a centralized User Access Management System.

DMSDocument Management System

Securely store, organize, and retrieve documents with version control using a Document Management System.

QC PlanningQuality Control System

Plan, schedule, and manage Quality Control testing and sampling activities effectively.

CVSCleaning Validation Software

Simplify the cleaning validation process with built-in workflows, traceability, and real-time monitoring.

PVSProcess Validation Software

Ensure process consistency with robust Process Validation Software covering IQ, OQ, PQ stages.

RSMSRegulatory System Management Software

Centralize global regulatory operations with a unified Regulatory System Management Software platform.

Compliance is built in — not bolted on

Every system in our suite is designed from the ground up for 21 CFR Part 11, EU Annex 11, and GMP requirements. Electronic signatures, complete audit trails, role-based access controls, and validation documentation are standard — not optional add-ons.

Delivered in partnership with AmpleLogic — a specialist pharma software provider trusted across global manufacturing facilities.

21 CFR Part 11 compliant electronic records and signatures across all systems

Audit-ready documentation available in real time — no manual assembly

Integrated suite covering the full pharma operations lifecycle

Reduced deviation cycle times through automated CAPA and change control

Training and certification tracking built directly into operations workflows

Calibration and preventive maintenance scheduled and documented automatically

Ready to modernize your pharma operations?

Whether you are starting with a single system or looking to deploy a fully integrated suite, our team can walk you through what the right fit looks like for your facility.

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