Process Validation System
Elevate Process Precision and Excellence
AmpleLogic’s Process Validation System 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
Why choose AmpleLogic Process Validation System?
AmpleLogic Process Validation System 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
Pique Process Validation with
AL’s Process Validation System
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
Hear From Our Customers
Frequently Asked Questions
What is Process Validation Software?
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.
What functions does Process Validation Software perform?
A Process Validation Software facilitates the automation and optimization of validation procedures within manufacturing, ensuring consistent adherence to quality and regulatory benchmarks.
What sets AmpleLogic’s Process Validation Software apart?
AmpleLogic’s Process Validation Software distinguishes itself through its tailor-made configurations, interactive dashboard, and specialized suitability for regulated industries, particularly the pharmaceutical sector.
In which sectors does AmpleLogic provide its solutions?
AmpleLogic extends its solutions to regulated industries such as Life Sciences, Food & Beverages, Cosmetics, Medical Devices, among others.
Does our Process Validation Software adhere to global standards?
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.
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:
Your benefits:
- Client-oriented
- Independent
- Competent
- Results-driven
- Problem-solving
- Transparent
What happens next?
Schedule a call at your convenience
Discovery and consultation session
Get your custom proposal
