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Compliance Solutions for FDA 21 CFR Part 11

Atharvana Infotech provides industry leading software and services to companies who must be compliant with FDA 21 CFR Part 11. Our solutions deliver actionable real-time intelligence to operations managers and senior executives, using software solutions that monitor, record, analyze and optimize production and cleaning processes used in manufacturing operations.

The US Food and Drug Administration Department administers manufacturing, export or import of Food & Beverages (Processed, Food, Dairy Products), Drugs (Pharma), Medical devices (Labs which are part of Clinical Trials), Vaccines, Blood & Biologics, Animal & Veterinary, Cosmetic and Tobacco products.

The salient features of the system are:

  • Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records
  • The ability to generate accurate and complete copies of records in both human readable and electronic form
  • Protection of records to enable their accurate and ready retrieval throughout the records retention period
  • Limiting system access to authorized individuals
  • Use of secure, computer-generated, time-stamped audit trails
  • Use of operational system checks to enforce permitted sequencing of steps and events
  • Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand
  • Use of device checks to determine the validity of the source of data input or operational instruction
  • Determination that persons who develop, maintain, or use electronic record/electronic signature systems has the education, training, and experience to perform their assigned task
  • The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures
  • Use of appropriate controls over systems documentation
  • Our solutions deliver actionable real-time intelligence to operations managers and senior executives, using software solutions that monitor, record, analyze and optimize production and cleaning processes used in manufacturing operations.

Cleaning

  • Clean-In-Place
  • Manual Cleaning
  • Reports

Production

  • Material loss
  • Traceability
  • Yield

A.Optimize your cleaning process

  • Clean-In-Place
  • Intelligent Manual Cleaning

Our software solutions apply data science to the entire cleaning process. We combine automatic data collection with the latest in mobility and business analytics for compliance reporting, process monitoring, and optimization solutions. Access compliance records when and where you need them, with automatic back-up, filter, search and sort. Monitor progress in real time, record completion status, manage exceptions and verify every cleaning record relied on in your food safety program.

  • Optimize energy and water use
  • Validate, review wash processes and goals
  • Manage chemical use more efficiently
  • Collect, store and analyze detailed process information

Clean-In-Place

Providing visibility from the plant floor to the corporate office, It monitors every step of every wash. Automated data collection generates wash records in real-time using benchmarks, baselines, dashboards, alerts and exception reporting to drive consistency, quality and cost reduction.

Data-driven process improvement

  • Minimize CIP Time
  • Maximize Safety
  • Real-time monitoring
  • Optimize CIP costs
  • Compliance reporting

Reports

  • Wash Reports
  • Exception Reports
  • Unit Inspection Reports
  • Chemical & Utility Reports

Validation

  • Configurable Alerts
  • Paperless compliance reporting
  • Automate

Analytics

  • Daily dashboards
  • Predictive rules
  • Event-triggered reports
  • Dynamic Table-based data

Industry which need to comply

Any manufacturer exporting to the USA and in the field of Food & Beverages, and Pharmaceuticals need the CIP process in place

Intelligent Manual Cleaning

Our software provides visibility into every step of their quality and sanitation programs — driving consistency, efficiency and quality across their organization while cost effectively providing audit, compliance, to meet food safety compliance requirements. Convert paper-based activities into an electronic quality process with reporting and analytics that makes performance easy to schedule and simple to track. Monitor and manage performance of the quality and sanitation program with live data. Pinpoint challenges, monitor corrective action and resolution.

  • Visibility across workflows and manual cleaning processes
  • Increased production availability
  • Compliance reporting
  • Data-driven process improvement
  • Cloud based, cost effective, fast deployment hosted solution

Reports

  • Paperless records
  • Exception reports
  • Schedule assistant
  • Cleaning supplies reports

Validation

  • Electronic results & Validation
  • Automated system

Analytics

  • Dashboards
  • Graphic visualizations over time of parameters
  • Trend analysis
  • Dynamic table-based data

B.Optimize production using data and insights taken directly from your operations.

  • Material Loss
  • Traceability
  • Yield

Our production optimization solutions are offered as a comprehensive bundle, or as one or more separately installed functional modules that address a particular need. Our powerful analytics software allows scalable business practices to be deployed within an enterprise that has acquired plants or evolved into a heterogeneous automation control environment.

  • Transparency into loss and efficiency for continuous improvement
  • Integrated view of your entire operation
  • Advanced benchmarking, analytics, and quality reporting

These solutions are useful for all the industries which are in manufacturing process including Pharma, Dairy, Food Processing, Automobiles, Cement, Engineering, Healthcare, Electronics, etc.,

Material Loss

Material Loss module allows you to isolate and measure the raw material that was purchased and that did not make it into finished product, gain better insight into production bottlenecks, and manage variances to reduce shrink. Use exception reports, visualizations, and advanced reporting services to gain insight into performance, and to eliminate reliance on paper worksheets. Material Loss module allows scalable business practice to be deployed within an enterprise that has acquired plants or evolved into a heterogeneous automation control environment.

  • Transparency into loss and efficiency for continuous improvement
  • Integrated view of quality tests at critical process steps
  • Scheduling assistant for receiving, processing and finish areas
  • Loss and other analysis that imports into your accounting system
  • Compatible with all existing plant equipment and software and SOPs Industry

Traceability

Traceability module allows you to quickly locate all finished product containing ingredient from a particular supplier, lot code, or date range. A simple to read graphic visualization identifies the point of origin, to immediately isolate all products that could have been affected, as well as the process path unique to the parameters in question. All co-mingling, by-products, and mixed lots are quickly and securely identified, and wash records are fully integrated and accessible with the unit analysis.

  • Connects to any plant hardware and software
  • Patented genealogy optimized for complex manufacturing
  • Integrated views of production, cleaning, test data
  • Easy to use case analysis for all types of threats
  • Intuitive search tools with point of origin reporting

Yield

Yield module automatically records every parameter for every step in your production process, and it summarizes this information into a production record. View the results “live” to guide critical real time decisions and monitor each batch while it is being made. Use exception reports, visualizations and advanced analytics to gain insight into process variances that impact quality and yield.

  • Collect, store and report batch details and contribution to daily totals
  • Inspection Record for every production Unit used in the operation
  • Variance analysis on material loss areas, with exception reporting
  • Real-time dashboard interfaces with analytics threads
  • Industry and enterprise benchmarking metrics

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