Data Integrity Experts| Malcom Associates
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Data and Process Integrity

Data Integrity

Data integrity issues linger when unnecessary redundancy and complexity make knowledge and data hard to understand and maintain. It is therefore vital to asses and understand the workflow (processes), real data requirements (manual and electronic), procedures, and employee competencies, before consistency and data accuracy can be improved.

Our Approach to Address Data Integrity Issues for Over 30 Years

We focus on REDUCING the complexity of Batch Records, data, SOPs, and supporting systems.

Our Batch Record redesign and simplification approach:

  • Defines the rules and guidelines for Batch Record creation, workflow, data and documentation requirements (see our Batch Record guidance).
  • Assesses and identifies process, workflow, and compliance gaps, (between what you need and what you have) and unnecessary redundancies.
  • Provides a design to ensure clear instructions and sufficient space to record entries
  • Tests and confirms the Batch Record and supporting system improvements.
  • Provides justification history for improved changes to support routing and approval.
  • Complies with cGMP regulations and PIC/S guidance.
  • Is first step to migrate from a paper-based system to MES/EBR, LIMS, and Data Acquisition and Monitoring systems.

Malcolm’s Simplification methodology prevents redundant representation of information, e.g., data (manual and electronic), Batch Records, forms, log books, procedures, labels, testing, methods, trends, etc

Along with Batch Record simplification, Batch Record guidelines help to improve human knowledge and ensure complete, accurate, and consistent data that supports compliance with the ALCOA+ guidance.

Process Integrity

Process Integrity is defined simply by asking the question ‘does the operational process and written procedure(s) follow the tasks and workflow of the validated process’?

Process integrity can be compromised if:

  • Written procedures do not follow the actual task(s) and sequence of the operational process
  • The actual process/task(s) as executed do not follow the written procedure
  • All the necessary tasks needed to perform the operational process are not in the written procedure
  • The procedure is not understood or followed by the individual(s) performing the task(s)

Process integrity does not have an ALCOA+ guideline to reference, but in most cases process integrity goes ‘hand-in-hand’ with data integrity.

The batch record should be designed to record information in the same sequence as the operational process and contain data requirements as defined in related SOP(s).  If they do not align, then critical data and process integrity can inadvertently be compromised.

Example of an FDA observation:

Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

Your cleaning procedures for non-dedicated equipment, including your tablet presses and (b)(4), are inadequate. Our investigators observed drug residue from previously manufactured drug product inside the (b)(4) on one of your tablet presses documented and released as clean by your quality unit. You used this tablet press to manufacture several potent and non-potent drug products. Investigators also observed residue on the (b)(4), as well as in the (b)(4) duct of your (b)(4). Cleaning and preventative maintenance procedures for your (b)(4), installed in XXXX, did not include cleaning instructions for these areas or a regular inspection of the air ducts.

This observation states, the procedure may not have been followed as written, the process was checked and released by the quality unit as being completed, and the procedure does not have all the steps/tasks necessary to verify that the cleaning process was performed correctly.  Therefore, process and data integrity were compromised.