Medical & Pharmaceutical Quality Control

In their highly regulated industries, Medical and Pharmaceutical manufacturers must prevent defects before they happen.

Medical & Pharmaceuticals

Medical Device and Pharmaceutical manufacturers produce products that improve and save lives every day. Products must be of the highest quality to meet customer demands for safety and efficacy. In addition, Medical Device and Pharmaceutical manufacturers must meet stringent government regulations and oversight while managing an increasingly global supply chain.
As a quality manager for a Medical Device or Pharmaceutical manufacturer, you need to:

  • Proactively prevent defects and nonconformities
  • Ensure regulatory compliance and documentation
  • Easily prepare audit documentation and reports
  • Reduce recall risk and response time

 

Medical & Pharmaceuticals Quality Control with InfinityQS

Medical Device and Pharmaceutical quality managers rely on InfinityQS® ProFicient Statistical Process Control (SPC) software to meet these needs. ProFicient provides automated, real-time quality control and monitoring to ensure your Medical Device and Pharmaceutical products meet quality and global regulatory compliance requirements.

With ProFicient, C-Axis moves data back and forth with their customers, allowing for improved pharmaceutical quality assurance across the supply chain. 

A proactive approach to quality

Medical and Pharmaceutical quality control keep manufacturing processes operating at the highest efficiency. Raw materials and subcomponents for medical devices and pharmaceuticals are expensive. Finding defects late in production increases scrap and rework along with shipment delays. Quality managers need to proactively prevent defects by monitoring processes closely at the earliest production stages. With InfinityQS ProFicient SPC software, quality managers gain visibility to automated, real-time production-floor data collection, alerts, monitoring, and analysis that:

  • Enable corrective and preventive action (CAPA) on a process parameter before a problem develops
  • Reduce rework and scrap
  • Reduce production and shipment delays
  • Improve product quality and process efficiency

 

A proactive approach to quality with InfinityQS

The ProFicient On Demand cloud solution enables global real-time visibility of not only your own plants, but also the raw materials or subcomponents before they ever leave our suppliers’ facilities, no matter where they are located. This level of supplier monitoring prevents nonconforming materials from entering your production process, eliminating the need for acceptance sampling and reducing inventory.

Regulatory compliance

Compliance with government regulations such as the U.S. Food and Drug Administration (FDA), European Union directives, the European Medicines Agency (EMA), and Health Canada is a given for Medical Device and Pharmaceutical manufacturers. InfinityQS ProFicient software provides quality managers with real-time documentation and reporting, product traceability, and validation of software to:

  • Always be “audit ready” with documentation and reports for internal or regulatory/certification audits (ISO 13485, ISO 9001, FDA 21 CFR 820 and 21 CFR Part 11, and ICH Q10)
  • Enable proactive steps to prevent recalls
  • Quickly respond to product recalls and counterfeit products
  • Easily and quickly validate software
  • Improve medical quality control (QC medical)
Regulatory compliance with InfinityQS

Medical & Pharmaceutical quality assurance and industry compliance

ProFicient’s built-in functionality helps Medical Device and Pharmaceutical manufacturers comply with government regulations and industry standards for quality and safety. ProFicient is a robust solution that can stand up to an FDA or internal audit while easily meeting the challenging FDA 21 CFR Part 11 requirements. ProFicient boasts built-in checklist features needed to comply with Hazard Analysis and Critical Control Points (HACCP), Standard Operating Procedures (SOP), Critical Quality Attributes (CQAs) and Critical Process Parameters (CPP).

ProFicient also offers Audit Trail Logging which provides a history of all changes made to any database record including sample data limits, alarm rules, change history, metadata, specification limits, and control limits.

The strict access control features support all of FDA 21 CFR Part 11 technical requirements for electronic signatures including Password Aging, Recycling, Lockouts, Length, and Encryption.

The Security Violation Logs track and report security violations by individual users and their location. Access Logs track individual user access into and out of applications.
 

Lot Genealogy reports provide a complete view of the incoming/outgoing product relationship complete with statistical summary information.

ProFicient’s Lot Genealogy and Reporting functionality enables Medical Device and Pharmaceutical manufacturers to track raw materials or component lot codes throughout manufacturing operations. For investigation purposes, genealogical "trees" can be created for any lot. These reports allow you to determine:

  • Materials used in the production of a specific finished lot
  • Where incoming raw materials were consumed
  • Root causes of nonconforming lots
  • Information critical for responding to product recalls
  • Which final lots were created from incoming lots
  • Information critical for counterfeit prevention and response
  • Unique Device Identification (UDI) information necessary for future FDA medical device labeling requirements
  • Current pharmaceutical quality assurance status
Dynamic Scheduler
You can specify unique, time-based intervals based on the product, process, or even the workstation. Windows automatically pop up, clearly identifying when data collections are due. If a failure is detected or if no data is collected, ProFicient can automatically send notifications, email administrators, or even force users to specify assignable cause codes and corrective actions.

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With ProFicient, audits are easier with instant access to quality records and electronic documentation needed to demonstrate compliance. ProFicient is a robust solution that can stand up to third-party certification audits or internal audits for Quality Management Systems (QMS) that require ISO 13485:2012, Good Manufacturing Practice (GMP), or ISO 9001 as required by the FDA, Health Canada (CMDCAS), EMA, Japanese PAL, EU Directive 90/385/EEC, ICH Q10, or other agencies. Creating reports takes only minutes instead of hours or days, eliminating the need for spreadsheets.

ProFicient boasts built-in checklist- and workflow-alerting features needed to comply with Hazard Analysis and Critical Control Points (HACCP) and Standard Operating Procedures (SOP). With ProFicient, you can incorporate workflow requirements at the production-floor level, providing automatic data collection prompts to operators. InfinityQS’s real-time Dynamic Scheduler offers visual checklists to operators, reminding them when to perform HACCP, SOP, and other critical quality checks.

 
When enabled, Database Auditing provides full traceability for any modification, edit, or change to any database record. Traceability records are easily viewed in a variety of ways, but they cannot be edited. Whenever a record modification or deletion is attempted, ProFicient’s Reason for Change tracking feature forces users to select a reason for the modification from a drop-down list. Additionally, free-form comments are required. When specified, a Change History and Reason for Change Report can accompany any chart printout.
 

Additionally, InfinityQS maintains a comprehensive statistical validation of our SPC software products to ensure the accuracy and validity of the calculations performed within. This statistical validation is performed by our staff of degreed Industrial Statisticians and made available in electronic format suitable for inclusion by our FDA-regulated clients in their own validation documentation. This data helps maintain efficient medical quality control in a global supply chain.


 
InfinityQS provides test cases, validation scripts, and validation services so that Medical and Pharmaceutical clients can perform full, functional verifications of their ProFicient installations. FDA-regulated clients have the opportunity to leverage our validation scripts for:
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
These comprehensive scripts provide a solid foundation for clients to perform their own internal validation of the InfinityQS SPC quality system. InfinityQS also offers onsite support to complete these validation tasks.
 
Manufacturers in the Pharmaceutical industry must also comply with FDA, U.S. Pharmacopoeia (USP), or other international Pharmacopoeia requirements for Net Weight Control and Content Uniformity. The Net Weight Control feature in ProFicient supports Pharmacopoeia Weight Variation and Content Uniformity requirements; in addition, ProFicient provides related documentation and reporting to support the needs of global manufacturers.

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