Data Integrity

Securing the integrity of your electronic data and records is critical for safeguarding patient safety

Data Integrity Services

signal-management

Data Integrity Risk Assessments

We take a consistent, standardized approach when performing data integrity risk assessments to fully encompass the requirements documented by the US FDA, EMA, MHRA,...

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Data Integrity Risk Assessments

We take a consistent, standardized approach when performing data integrity risk assessments to fully encompass the requirements documented by the US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and PDA.

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pharmacovigilance

Policies & Procedures Framework

We will ensure that data integrity is “built-in” from the start. Our data integrity consultants can have a QMS framework ready in a few weeks.

Policies & Procedures Framework

We will ensure that data integrity is “built-in” from the start. Our data integrity consultants can have a QMS framework ready in a few weeks.

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global-literature-review

Essential Training for Your Organization

Our catalog of Data Integrity training courses can be provided ‘as is’ or tailored to include examples from your daily operations.

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Essential Training for Your Organization

Our catalog of Data Integrity training courses can be provided ‘as is’ or tailored to include examples from your daily operations.

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computer-system-validation

Data Governance Programs

We guide you through the steps of implementing a Data Integrity Program to monitor data integrity practices and ensure they continue to mature. 

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Data Governance Programs

We guide you through the steps of implementing a Data Integrity Program to monitor data integrity practices and ensure they continue to mature. 

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Submissions

Standard Compliant Documentation, Tailored for You

We tailor our standard suite of documents, built from US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and PDA data integrity guidelines, to fit your...

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Standard Compliant Documentation, Tailored for You

We tailor our standard suite of documents, built from US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and PDA data integrity guidelines, to fit your organization. 

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compliance

ALCOA Principles Applied

We follow a consistent, standardized approach when performing data integrity risk assessments to fully encompass ALCOA principles and requirements documented by the US FDA,...

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ALCOA Principles Applied

We follow a consistent, standardized approach when performing data integrity risk assessments to fully encompass ALCOA principles and requirements documented by the US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and PDA.

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Data Integrity Risk Assessments

Everyone has heard the acronym "ALCOA", but our experts have experience assessing real-life situations vs. the principles of ALCOA to identify data integrity risks.

The purpose of a data integrity risk assessment is to provide you with the information you need to mitigate data integrity risks before your organization has a serious data integrity issue.

ProPharma’s data integrity consultants follow a consistent, standardized approach when performing data integrity risk assessments to fully encompass the requirements documented by the US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and PDA.

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Here are the steps we take:

  • Meet to discuss your industry, products, and markets to determine the appropriate regulatory guidelines and any specific areas of concern, e.g., from CAPAs or past audits.
  • Tailor our standard assessment checklists to place the emphasis on the areas of highest risk.
  • Conduct the data integrity risk assessment – policies and procedures first, then specific systems and processes. The assessments include demonstrations of system functionality, review of policies and procedures, interviews with subject matter experts, and review of validation documentation.
  • Provide a Data Integrity Risk Assessment report identifying the areas of data integrity risk. Each risk is categorized as ‘critical’, ‘major’, or ‘minor’ to aid in prioritization of remediation activities.
  • Provide a Report of Recommended Actions for closure of each data integrity risk.
  • Facilitate follow-up meetings to ensure that the risks and recommendations are understood.

Data Integrity Framework of Policies & Procedures

A robust suite of Policies, Procedures, Work Instructions, and Templates provides the framework to ensure that data integrity is “built-in” from the start. ProPharma’s experienced data integrity consultants can have a QMS framework ready in a few weeks.

Here are the steps we take:

  • Meet to discuss what makes your organization unique, e.g.,
    • Industry-specific regulations, e.g., AOPO, CAP, COLA
    • Organization structure, roles, and responsibilities
    • Computer systems and tools already in use
  • Tailor ProPharma’s standard suite of documents, built from US FDA, EMA, MHRA, WHO, PIC/S, ISPE, and PDA data integrity guidelines, to fit your organization.
  • Solicit feedback on the preliminary suite of documents and make adaptations before finalizing the Policies, Procedures, Work Instructions, and Templates.
  • Develop a Quality Manual to summarize the Policy and Procedure framework and provide an overview for employees, auditors, and inspectors.
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Man using mobile phone tablet and laptop next to stethoscope and spiral notebook

Data Integrity Training

Delivering the right level of training at the right time is essential for embedding the principles of data integrity into company culture.

ProPharma has a catalog of Data Integrity training courses that can be provided ‘as is’ or tailored to include examples from your daily operations.

  • Short training courses on Data Integrity Principles, suitable for Data Integrity program implementation and annual refresher training
  • Longer training courses on advanced Data Integrity topics such as:
    • ALCOA in Practice
    • Data Integrity Roles & Responsibilities
    • Data Governance Models
    • Digital Signatures
    • Computer System Validation

Data Governance Programs

A Data Governance program is more than simply determining who ‘owns’ the data.  It’s a program to monitor data integrity practices in real-time and ensure that they continue to mature.

ProPharma’s data integrity consultants will guide you through the steps of implementing a Data Integrity Program that includes:

  • A structured program with defined roles and responsibilities for both leaders and subject matter experts
  • Processes for real-time monitoring of data integrity health through ongoing review of internal audit findings, metrics, and incident reports
  • Processes for prioritizing and initiating course corrections to ensure that issues are not repeated, and data integrity health metrics continue to improve
  • Standard process for building a roadmap to improve the organization’s Data Integrity program through strategic investments and targeted process improvements
Medical professionals business professionals working at a conference table

Meet Our Data Integrity Experts

deb-bartel

Deb Bartel

Senior Vice President, Quality Assurance

bob-verhoeff

Bob Verhoeff

Associate Director, Computer System Validation & Data Integrity

rodrigo-perez

Rodrigo Perez

Associate Director, Computer System Validation and Data Integrity

john-gow

John Gow

Senior Consultant

News & Insights

EU Regulatory Sciences EU Pharmaceutical Legislation Reform: Where Are We Now?

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EU Pharmaceutical Legislation Reform: Where Are We Now?

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...

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Press Releases ProPharma Announces Changes to Its Executive Leadership Team

April 10, 2024

ProPharma Announces Changes to Its Executive Leadership Team

Strategic Leadership Appointments to Propel Global Growth RALEIGH, April 10, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences...

Press Releases ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

January 24, 2024

ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...

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January 4, 2024

Innovation and the Black Swan Prodigy Whitepaper

Check out our comprehensive whitepaper, "Innovation and the Black Swan: the Imperative of AI-enabled clinical research," for an in-depth look at how embracing AI-enabled tools and technologies is...

Press Releases Awards EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

Press Releases Awards ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases Awards ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

August 15, 2023

ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...

Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

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Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

Press Releases ProPharma Announces Changes to Its Executive Leadership Team

April 10, 2024

ProPharma Announces Changes to Its Executive Leadership Team

Strategic Leadership Appointments to Propel Global Growth RALEIGH, April 10, 2024 – ProPharma, the leading global provider of regulatory, clinical, and compliance services for the life sciences...

Press Releases ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

January 24, 2024

ProPharma Announces the Appointment of Vicki Gashwiler as Vice President of Clinical Operations, Medical Technology

RALEIGH, January 24, 2024, ProPharma Group (ProPharma), the leading global provider of regulatory, clinical, and compliance services for the life sciences industry, and a portfolio company of Odyssey...

Company News Press Releases Innovation and the Black Swan Prodigy Whitepaper

January 4, 2024

Innovation and the Black Swan Prodigy Whitepaper

Check out our comprehensive whitepaper, "Innovation and the Black Swan: the Imperative of AI-enabled clinical research," for an in-depth look at how embracing AI-enabled tools and technologies is...

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Press Releases Awards EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Entrepreneur Of The Year® celebrates ambitious entrepreneurs who are building a better world. RALEIGH, NC, November 27, 2023 – Ernst & Young LLP (EY US) today announced that Chief Executive Officer,...

Press Releases Awards ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Raleigh, NC, October 11, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...

Press Releases Awards ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

August 15, 2023

ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies

ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...

Previous Award Arrow Next Award Arrow
EU Regulatory Sciences EU Pharmaceutical Legislation Reform: Where Are We Now?

March 26, 2024

EU Pharmaceutical Legislation Reform: Where Are We Now?

On April 26, 2023, the European Commission proposed a new package of pharmaceutical legislation1 to revise many of the currently applicable Regulations. Background This revision is considered by many...

Medical Information Privacy PIPL China Understanding PIPL: Compliance and Implementation Challenges

March 25, 2024

Understanding PIPL: Compliance and Implementation Challenges

What is PIPL? Personal Information Protection Law (PIPL) was approved in China on August 20, 2021. It was the first comprehensive data protection legislation in the region. The Law entered into...

LPPV PSMF QPPV Pharmacovigilance Achieving Success with Regulatory Intelligence in Pharmacovigilance

March 25, 2024

Achieving Success with Regulatory Intelligence in Pharmacovigilance

What is Regulatory Intelligence in Pharmacovigilance? In Pharmacovigilance (PV), Regulatory Intelligence involves the collection and analysis of publicly accessible PV regulatory guidelines and...

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow

Customized Strategy. Globally Scaled Solutions

ProPharma helps clients mitigate data integrity risks and ensure compliance with FDA, EMA, MHRA, and other agency standards.