AmpleLogic PVS

Process Validation Software

Elevate Process Precision and Excellence

AmpleLogic’s Process Validation Software empowers regulated industries like Life Sciences, Food & Beverages, Cosmetics, Gene Therapy, and Medical Devices to achieve unparalleled process accuracy and excellence. By keeping businesses on track, it ensures compliance, efficiency, and transparency in operations, setting new standards for industry performance.

Protocol Management

Enables creation, management, and tracking of validation protocols, with customizable templates for diverse processes

Document Management

Facilitates organization, storage, and retrieval of validation documents, including SOPs, batch records, and reports

Data Collection and Analysis

Streamlines data collection from diverse sources and offers analysis tools for ensuring process compliance

Change Control

Manages process changes, ensuring compliance through evaluation, documentation, and validation

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Why choose AmpleLogic Process Validation Software?

AmpleLogic Process Validation Software stands out as the ideal solution for validating complex manufacturing processes. Our state-of-the-art software ensures:

Electronic Signatures

Enables secure approval and verification of validation documents and processes

Real-time Monitoring

Monitors process parameters and alerts for deviations or issues

Advanced Integration

Integrates with ERP, QMS, APQR systems for automated data exchange

Risk Assessment and Management

Identifies and mitigates risks to ensure product quality and safety

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Pique Process Validation with
AL’s Process Validation Software

Auto Protocol Drafting

Instant auto protocol drafting as per SOP (standard operating procedure)

Audit Trail

Tracks all system changes and activities, ensuring data integrity and regulatory compliance

Validation Reporting

Generates Smart reports with data visualization and predictive analysis summarizing validation activities, results, and conclusions for regulatory submissions

Compliance Assurance

Maintain regulatory compliance with our FDA-compliant solution, adhering to 21 CFR Part 11 and other industry standards

Version Control

Implement version control for documents and procedures to track changes, revisions, and approvals systematically

Training and Competency Records

Maintain records of employee training and competency assessments to ensure a skilled and compliant workforce

Equipment Integration

Integrates perfectly with equipments such as HPLC, balances, machines, etc

Verification

Validate resources like equipment, room, solutions before usage to avoid noncompliance

Version Master Plan Automation

Automate Version Master Plan (VMP) schedules for Process Validation

Workflow Automation

Streamline approval workflows, enhancing the accuracy and efficiency of data entry and validation

User-friendly Interface

Experience an intuitive interface that simplifies logbook management for users at all levels

Controls and Monitors CPP & CQA

Helps businesses meet Critical Process Parameters and Critical Quality Attributes

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Frequently Asked Questions

Process validation software is a type of software designed to assist organizations in validating and monitoring their manufacturing processes. These processes can range from pharmaceutical production to food processing to automotive manufacturing. The software helps ensure that these processes consistently produce products that meet predetermined quality standards and regulatory requirements.

A Process Validation Software facilitates the automation and optimization of validation procedures within manufacturing, ensuring consistent adherence to quality and regulatory benchmarks.

AmpleLogic’s Process Validation Software distinguishes itself through its tailor-made configurations, interactive dashboard, and specialized suitability for regulated industries, particularly the pharmaceutical sector.

AmpleLogic extends its solutions to regulated industries such as Life Sciences, Food & Beverages, Cosmetics, Medical Devices, among others.

Our Process Validation Software is meticulously crafted to align with international standards prescribed by regulatory bodies such as the US FDA, EMA, MHRA, and others.

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Your Pharma Automation Starts Here

We’re here to address your inquiries and assist you in identifying the solutions that best align with your requirements. Here’s why choosing us is your strategic advantage:

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Discovery and consultation session

3

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