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.

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. 

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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Hands gesturing around a table with various charts and graphs

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 Bio Photo

    Deb Bartel

    Vice President of Quality Assurance

  • Bob Verhoeff Bio Photo

    Bob Verhoeff

    Associate Director, Computer System Validation & Data Integrity

  • Rodrigo Perez Bio Photo

    Rodrigo Perez

    Associate Director, Computer System Validation & Data Integrity

News & Insights

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

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Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

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

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Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

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News & Insights

ProPharma Receives 2024 CRO Leadership Award

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ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

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Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

ProPharma and PBL introduce Cell Factory Box for decentralized Cell & Gene Therapies manufacturing, reducing costs and improving patient access to life-saving treatments.

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

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ProPharma Now Certified as Medidata Rave EDC Accredited Partner

ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

Previous Post Arrow Next Post Arrow
ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

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

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

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

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

Previous Award Arrow Next Award Arrow
Meet the Expert: Dana E. Vanderwall, PhD.

July 18, 2024

Meet the Expert: Dana E. Vanderwall, PhD.

Meet the Expert: Dana E. Vanderwall, PhD., a Senior Director Digital Transformation at ProPharma, shares insights on PSMF and robust quality management systems.

Regulatory Chemistry, Manufacturing, and Controls (CMC): What to Expect During Drug Development

July 16, 2024

Regulatory Chemistry, Manufacturing, and Controls (CMC): What to Expect During Drug Development

Navigate FDA IND process and discover how CMC sections are integral to drug development to ensure quality, safety, & potency for successful regulatory applications

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July 15, 2024

What is the FSP Model in Clinical Research?

Discover how the FSP model in clinical research offers flexible, cost-effective outsourcing for specific functions, enhancing drug discovery and trial efficiency.

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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

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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...

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Customized Strategy. Globally Scaled Solutions

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