QUALITY

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Smart Business Processes

Data Driven Decisions lead to Solid Compliance

Excellence in the various Quality processes is paramount throughout the whole life sciences industry. Medicinal products and devices, which have the potential to drastically change lives, must be developed with frictionless quality systems in place, to ensure controlled documentation and end-to-end compliance at any time. Quality assurance as such is a pretty broad concept. It covers all aspects of your process that can have an impact on patient outcomes.

The risk of not implementing comprehensive quality systems is well documented. The numerous yearly findings of authorities like FDA or EMA can still be devastating to a company with poor performance in quality.

Such findings can lead to substantial costs related to corrective measures, remediation and blocking of sites and product. Companies can face external costs like regulatory action, massive reputational damage, and a loss of market share.
US-based pharmaceutical organizations should work to assess and understand the following regulatory requirements from the Food and Drug Administration (FDA), including clinical requirements:

If your marketing ambitions post-approval include Europe, you should strongly consider aligning your quality system to ICH Q10 earlier in your development.

TOUCH

PROCESS

PROCESS

Continuous Improvement

Constantly verify the consistency of existing processes and whether existing specifications are appropriate and adequate.

TOUCH

PRODUCT

PRODUCT

Current Good Practice


GxP - the implementation of quality principles  for raw materials, the manufacturing process, packaging, transportation, and storage.

TOUCH

PEOPLE

PEOPLE

Quality-Driven Culture

Besides the obvious process excellence, a proper product the quality-driven culture remains a main factor to achieve quality.

Related Sub-Processes in Quality

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Audit Management

The increasing complexity and continuous changes in the regulatory environment push organizations to seek a more holistic and highly integrated approach to their audit management processes. Auditing is a vital function within a pharmaceutical company nowadays CAPA Management

HIGHLIGHTS

  • External audits
  • Internal audits
  • Regulatory audits
 

arivis-quality-CAPA-management

CAPA Management

To understand how to achieve quality in a regulated industry, you need to know that corrective and preventative actions (CAPA) are essential elements of quality management in GxP environments. The CAPA process is a commonly used tool to achieve operational excellence by identifying and mitigating non-conformances and deviations, both internally and externally.

HIGHLIGHTS

  • Event Mapping / Audit Scheduling
  • Structured Problem Analysis
  • Multidimensional (faceted) Search
  • Smart Follow-up Workflow
  • Effectiveness Check
  • Indicators and Signals
 

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SOP Management

Life science organizations developing or manufacturing pharmaceutical products will typically create, maintain and execute large amounts of standard operational procedures (SOP). The solid change control and deployment of SOPs are a fundamental to achieve compliance excellence.

Properly designed Standard Operating Procedures include step-by-step instructions as well as the following:

HIGHLIGHTS

  • Objective (Purpose)
  • Scope
  • Responsibilities
  • Accountability
  • References
  • Task Instructions (Procedure)
  • Documentation
 

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Change Control

Change management is specifically designed to evaluate, redesign, and implement new business processes, where processes are defined in standard operating procedures (SOPs). A well implemented change management pays back into improved business processes, efficient workflows, decreased project overhead, a better risk profile and an improved company culture.

HIGHLIGHTS

  • Collaborative authoring and editing
  • Document review and approval
  • Document protection and monitoring
  • Document control and printing functions
 

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Training Management

Post implementation training services often relateto process changes. With biomedion training services implementations are ready for success. The neuronOS Learning Management System (LMS) typically handles the processes related to ramp-up and adoption planning after larger implementations.

HIGHLIGHTS

  • Upload content
  • Deliver courses online
  • Onboarding process
  • User Enrollment, Learning plans
  • Ramp-up new users
  • Tracking and assessing learner performance
 

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Deviation Management

As a common mechanism to discriminate events based on their relevance and to objectively categorize them, concentrating resources and efforts in good quality investigations of the root causes of relevant deviations.

HIGHLIGHTS

  • Control of components, drug product containers, and closures
  • Production and process controls
    Packaging and labeling control
  • Holding and distribution
  • Laboratory controls
  • Complaints
 

arivis-regulatory-inspection-management

Inspection Management

Audits, safety inspections, engineering surveys, and quality checks are common in life sciences. While they add overheads, they are necessary to keep organizations in business.

HIGHLIGHTS

  • GMP inspections
  • Contract manufacturers (CMO)
  • Contract laboratories
 

iRAW


intelligent raw data archiving watcher
RAW Data, GxP Lab, Controls, SEND, loT

WATCH+
ARC+

IMAGE+
BYOD+
REPORT+

As well as all other Add-ons ...

iPQM


intelligent pharma quality management
QMS, qDMS, CAPA, Image QC, Issue Management

REPORT+

SIGN+
IMAGE+
BYOD+
BRAIN+
TRAIN+

As well as all other Add-ons ...

iTMF


intelligent trial master file
DIA eTMF, CRO Migration, Longterm Archiving

SIGN+

BRAIN+
REPORT+
ARC+
TRAIN+
COMPLY+
MIGRATE+

As well as all other Add-ons ...

iRCS


intelligent regulated content services
rDMS, RIM robot, IDMP/SPOR, promo mats

COMPLY+

WATCH+
ARC+
REPORT+
BRAIN+
SIGN+
TRAIN+

As well as all other Add-ons ...

RESOURCES

“Quality is never an accident; it is always the result of high intention, sincere effort, intelligent direction and skillful execution; it represents the wise choice of many alternatives.”

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