Kneat Blog

Addressing Data Integrity for Validation and GxP Testing within Life Sciences

Posted by Kneat Solutions on 31-Jul-2017 10:50:27

 

Background

Data Integrity is a major concern for the global pharmaceutical and medical device industries, across many of their business areas.   Global regulatory authorities have increased their inspection focus to ensure good Data Integrity practices are being implemented.  The increased focus results from inspection observations of significant deficiencies.

 

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Data Integrity related requirements have been defined in many different sections of the regulations.

At a high level, Data Integrity requires that information/data has been collected, documented and reported in a manner that accurately, truthfully and completely represents the truth.  It further requires that adequate controls are in place to ensure that any change to relevant data is managed and audit trailed etc.

Management has the responsibility to establish effective systems and processes to ensure the accuracy, truthfulness and completeness of data and information that is required.

The regulatory agency Data Integrity expectations are summarized with the acronym “ALCOA” standing for

Attributable:  who performed an action/changed a record and when; reference to source data

Legible:  data must be recorded in a durable medium and legible

Contemporaneous:  data must be recorded at the time work is performed with time/date data

Original:  original record or certified copy

Accurate:  no errors or editing without documented amendments

Life Science Industry regulations include Validation requirements along with “change control” and “continuous monitoring” for industry processes such as:

  • Equipment Validation
  • Computer System Validation
  • Analytical Instrument Validation
  • Cleaning Validation
  • Equipment Changeover
  • Test Method Validation
  • Process Validation

A quality e-Validation tool can address data integrity requirements and supports efficient comprehensive ALCOA compliance as follows:

ALCOA

Expectation

e-Val System Compliance

  Attributable

  Who, When

e-Val solution provides secure role based user access control; captures who entered data with time data stamp and audit trail.  Captures who changed approved data capturing the before, after, who, reason and when.

  Legible

  Durable medium, readable

e-Val solution captures data via document/form into a secure database

  Contemporaneous

  Data Recorded when work      done with time date stamp

e-Val solution provides for “real time” on-line e-data entry including attachments with e-sign, time-date stamp etc.

  Original

  Complete raw data      information (avoid  transcriptions)

e-Val solution provides for efficient-effective e-data entry including attachments (avoids transcriptions)

  Accurate

  No errors/no changes without   amendment-verified

e-Val solution provides for direct data entry with e-signature verification, audit trail and integrated change/deviation management

Several of the regulatory observations have cited deficiencies associated with “incomplete review of approved records” (i.e.  responsible persons have signed /approved records that were incomplete or incorrect).  A robust paperless validation tool can provide a level of assurance that the validation record has captured/signed/witnessed all required data, that issues have been identified/addressed/closed and that the final validation record has been reviewed and approved by all required persons/functions.

About Kneat

Kneat develops and markets the leading edge Kneat Gx software platform.  Kneat Gx is a paperless validation application which enables the Life Sciences industry to become fully electronic with their many validation and testing processes.  Data Integrity is a pillar of the Kneat Gx architecture helping our customers to deliver on “ALCOA”.  The system can deliver productivity increases in excess of 100%, cycle time reductions of up to 60% and a higher repeatable compliance standard.

 

 See how Kneat can help with your digital transformation!

 

Kneat Solutions Blog

Our next generation productivity software makes your Validation and Manufacturing processes paperless, more compliant and centrally managed.

Our customers are seeing productivity increase by more than 100% and cycle times reduced by more than 50%, leading to improved OEE.

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