CaliberQAMS - Caliber

CaliberQAMS

CaliberQAMS offers you a highly configurable, workflow-driven process automation designed as per 21CFR Part 11 and cGMP regulations. CaliberQAMS helps you in Creation, Review, and Approval of change request, deviation recording, and hence, automating your entire QA process. This results in easy planning, scheduling and executing self-inspections, vendor audits, and regulatory audits. Through an integrated approach, CaliberQAMS facilitates task management of follow-up actions through CAPA and Training.

Schedule a free demo

Product Highlights

Flowers

Seamless Integration with Other Systems

Integrates with other applications by interlocking subsequent process actions like holding a batch due to a deviation, training a team member, or processing a change of document.

Flowers

Pick and Choose Integrated Modules

A highly configurable framework which can mimic and adapt to current processes and improve them is used.

Flowers

Tasks & Action Items

The review, analysis and evaluation workflow can be configured with Quality Assurance (QA), Regulatory Affairs (RA) approvals.

Flowers

CAPA

Plantwise pendency reports with the dashboard to the QA head helps to keep track of incidents and their Corrective Actions and Preventive Actions (CAPA.)

Flowers

Customized Workflows

Workflows ranging from simple process divisions to complex workflows can be configured.

Flowers

Effectiveness Monitoring

A checklist for effectiveness monitoring can be configured and measured as per the defined frequency.

Flowers

Reports & Analytics

CaliberQAMS has a configurable home page with dashboards, analytics, and actionable workflows apart from your own dashboards and reports, ready for decision-making. Reporting engine schedules, generates, and sends various reports to different users.

Flowers

Audit Trail

Actions have audit trails and are certified with electronic signatures.

Flowers

Processes

Standard processes that can be implemented in CaliberQAMS are Change Control, Deviation, CAPA, Market Complaints, and Internal-External Audit. Other processes can be implemented as well, including Pharmacovigilance, Lab Incident Reporting, and OOS.

Flowers

Email Escalations

CaliberQAMS can notify multiple users of the process about a defined escalation. These escalations are configurable and can be predefined.

Read More

Effectiveness Monitoring with Caliber Quality Assurance Management System

Read More Quality Assurance

Make Your Product Compliant to 21 CFR Part 11

Read More Pharma Guidelines

GAMP5 Compliance of Pharma Software

Read More Pharma Guidelines

Explore Products

Caliber

APQR

To ensure the appropriateness and consistency of existing processes, the Annual Product Quality Review is a process required by Pharma GMP.

Caliber

BRM

Manage your entire life cycle of Batch Records from preparation to product release with CaliberBRM.

Caliber

DMS

Good document management is an essential part of the quality assurance system as per GMP requirements.

Nichelon5

CMS

Nichelon5 CMS helps the training coordinators and department managers to face the huge challenge of managing GMP personnel competency levels and status across the enterprise.

Caliber

LIMS

A robust tool for your laboratory, meticulously designed to help you drive better decisions, perform efficiently, and store data securely.

Caliber

QAMS

CaliberQAMS offers you a highly configurable, workflow-driven process automation designed as per 21CFR Part 11 and cGMP regulations.

Caliber

ESM

This product is for maintaining equipment's lifecycle (from procurement to disposal).

Caliber

eLog

eLog tracks and generates reports for Operational and non-operational activities including Area Usage, Equipment usage, Report Configuration, Checklist Issuance & Execution.

Caliber

Dashboards

Effective decision-making must be an informed and timely process. Accurate and relevant information when readily available forms the solid foundation of effective decisions.

Caliber

LabAssistant

CaliberLabAssistant is an intelligent voice responsive system forming part of the Caliber Product Suite – our newest and most exciting addition.

CaliberAPQR

To ensure the appropriateness and consistency of existing processes, the Annual Product Quality Review is a process required by Pharma GMP.

CaliberBRM

Manage your entire life cycle of Batch Records from preparation to product release with CaliberBRM.

CaliberDMS

Good document management is an essential part of the quality assurance system as per GMP requirements.

Nichelon5CMS

Nichelon5 CMS helps the training coordinators and department managers to face the huge challenge of managing GMP personnel competency levels and status across the enterprise.

CaliberLIMS

A robust tool for your laboratory, meticulously designed to help you drive better decisions, perform efficiently, and store data securely.

CaliberQAMS

CaliberQAMS offers you a highly configurable, workflow-driven process automation designed as per 21CFR Part 11 and cGMP regulations.

CaliberESM

This product is for maintaining equipment's lifecycle (from procurement to disposal).

CalibereLog

eLog tracks and generates reports for Operational and non-operational activities including Area Usage, Equipment usage, Report Configuration, Checklist Issuance & Execution.

CaliberDashboards

Effective decision-making must be an informed and timely process. Accurate and relevant information when readily available forms the solid foundation of effective decisions.

CaliberLabAssistant

CaliberLabAssistant is an intelligent voice responsive system forming part of the Caliber Product Suite – our newest and most exciting addition.

Quality Achievers trust Caliber.

Implementation of Caliber software has given us better confidence to face regulatory inspections. The execution was systematic, training was excellent, and service… Milan

CaliberBRM stands tall on the issues of Data Integrity & ALCOA, complying to all Regulatory requirements, and is a bliss for QA… JB Chemicals