RegionAmpleLogic PVS
Process Validation Software for Pharma Industries - AmpleLogic
Elevate Process Precision and Excellence
AI-Powered APQR Software
Annual Product Quality Reviews, Reimagined with AI
Annual Product Quality Review is a critical regulatory requirement for pharmaceutical and life sciences organizations. AmpleLogic’s APQR solution enables structured, compliant, and inspection-ready reviews by consolidating quality data, automating trend analysis, and generating audit-ready reports.
Trusted by 100+ Pharma Companies Globally
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
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
Data Collection and Analysis
Streamlines data collection from diverse sources and offers analysis tools for ensuring process compliance
Document Management
Facilitates organization, storage, and retrieval of validation documents, including SOPs, batch records, and reports
Change Control
Manages process changes, ensuring compliance through evaluation, documentation, and validation
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
Maintains regulatory compliance with FDA-compliant adherence to 21 CFR Part 11 and other industry standards.
Version Control
Implements version control for documents and procedures to systematically track changes, revisions, and approvals.
Training and Competency Records
Maintains records of employee training and competency assessments to ensure a skilled and compliant workforce.
Equipment Integration
Integrates seamlessly with equipment such as HPLC, balances, machines, and other laboratory instruments.
Verification
Validates resources such as equipment, rooms, and solutions before usage to avoid noncompliance.
Version Master Plan Automation
Automates Version Master Plan (VMP) schedules for process validation.
Workflow Automation
Streamlines approval workflows, enhancing accuracy and efficiency of data entry and validation.
User-Friendly Interface
Intuitive interface that simplifies logbook and validation management for users at all levels.
Controls and Monitors CPP & CQA
Helps organizations meet Critical Process Parameters (CPP) and Critical Quality Attributes (CQA).
Industries We Serve
Industry-Specific Software for Enhanced Quality and Compliance
Life Sciences
Apply Nelson Rules to detect abnormal process behaviour and statistically significant trends.
Pharmaceuticals
Ensure consistent and inspection-ready APQR execution aligned with regulatory requirements.
Medical Devices
Transform the medical device industry with software that enhances compliance.
Gene & Cell Therapy
Address the complexity of advanced therapies by capturing batch-specific data, deviations.
Food & Beverages
Conduct structured product quality reviews that support safety, consistency, and regulatory expectations.
Cosmetics
Maintain standardized APQR documentation and quality trend visibility to support regulatory.
Case Studies
FAQ’s
Get Answers to All Your Queries
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.
What sets AmpleLogic’s Process Validation Software apart?
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.
The Food and Drug Administration (FDA) of the United States provides a document known as FDA Form 483 following an inspection. It lists any possible infractions or problems that were discovered when reviewing a company’s procedures, including production, quality control, and documentation. Process validation software is used, particularly in the pharmaceutical and medical device industries, to make sure that production processes fulfill FDA regulatory standards for creating safe and effective goods.
If the FDA discovers difficulties with a company’s use of software to validate procedures (such as incomplete testing or mistakes in data documentation), it may issue a Form 483 outlining the precise flaws. Businesses must make sure their software conforms with FDA regulations, which include electronic records and signatures (21 CFR Part 11), in order to prevent this.
