Data Integrity

Brevitas Consulting - Pharmaceutical

From Product Development to Distribution and Safety Monitoring

“Data integrity is a fundamental element of a pharmaceutical quality system and has a direct impact on product-related decisions and traceability. Accountabilities for ensuring data integrity run throughout an organization, from product development, through manufacture and testing, to product distribution and safety monitoring.” ISPE Special Report: Data Integrity (March – April 2016).

From Product Development to Distribution and Safety Monitoring

“Data integrity is a fundamental element of a pharmaceutical quality system and has a direct impact on product-related decisions and traceability. Accountabilities for ensuring data integrity run throughout an organization, from product development, through manufacture and testing, to product distribution and safety monitoring.” ISPE Special Report: Data Integrity (March – April 2016).

Brevitas Consulting - Pharmaceutical
Brevitas Consulting - Pharmaceutical

Overcoming Data Growth Issues

The importance and amount of data being generated to ensure product quality and patient safety continues to grow. Regulatory agencies are noticing a significant increase in data integrity issues, and drug manufacturers have been warned to protect the integrity of their data to meet regulatory requirements.  Proper controls around data integrity must be enforced and constantly re-evaluated.

Brevitas Consulting - Pharmaceutical

Overcoming Data Growth Issues

The importance and amount of data being generated to ensure product quality and patient safety continues to grow. Regulatory agencies are noticing a significant increase in data integrity issues, and drug manufacturers have been warned to protect the integrity of their data to meet regulatory requirements.  Proper controls around data integrity must be enforced and constantly re-evaluated.

Brevitas Consulting - Pharmaceutical

Focus on Data Integrity

The style and focus of regulatory pharmaceutical inspections have seemed to change almost overnight. The new focus is on data integrity. A surprising development is almost all regulators are unified in their focus and renewed application of GDP ALCOA concepts to cGMP.

Focus on Data Integrity

The style and focus of regulatory pharmaceutical inspections have seemed to change almost overnight. The new focus is on data integrity. A surprising development is almost all regulators are unified in their focus and renewed application of GDP ALCOA concepts to cGMP.

Brevitas Consulting - Pharmaceutical
Brevitas Consulting - Pharmaceutical, Biopharmaceutical, Chemical, Food and Beverage

Attributable, Legible, Contemporaneous, Original and Accurate

In recent years, FDA, MHRA, WHO and Health Canada have authored draft guidance and standards governing the expectations for future inspections. Brevitas can help you weather the storm of Data Integrity focused inspections with our service offerings.

Brevitas Consulting - Pharmaceutical, Biopharmaceutical, Chemical, Food and Beverage

Attributable, Legible, Contemporaneous, Original and Accurate

In recent years, FDA, MHRA, WHO and Health Canada have authored draft guidance and standards governing the expectations for future inspections. Brevitas can help you weather the storm of Data Integrity focused inspections with our service offerings.

Audit & Assessment

  • Mock Audits
  • SDLC Review
  • Vendor Audits
  • Validation Review
  • Gap Analysis

Planning

  • Program Prevention & Detection
  • Distinct Cloud & SAAS Validation Strategy Development
  • Identity & Security Plan Development
  • Remediation Plan Development

Remediation

  • System/Software Upgrades
  • Validation
  • Quality Agreement Development
  • Procedural Controls
  • Training

Case Studies

Brevitas Consulting - Pharmaceutical Case Studies

Compliance Project

An internal audit of a top generic pharmaceutical manufacturer identified deficiencies in their legacy computerized systems related to SDLC requirements (GAMP standards, FDA 21 CFR Part 11 & Data Integrity). Brevitas consultants were enlisted to deliver an effective solution to bring the existing systems into regulatory compliance.

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