How Paperless Validation Systems Support Data Integrity
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.
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.
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