As all know Data Integrity is very hot topic for all Pharmaceutical Industries and it is must to follow Data Integrity Policy in Manufacturing Plant.
What this policy should include and what is the minimum requirement to add in Data Integrity Policy?
Herewith in my article I have added definitions, general requirements and ALCOA principle in very short and easy to understand form.
This information may help you to impart training on Data Integrity and also help you us implement at your facility.
General Statement
(Company Name), has established, documented, implemented and maintained a Quality Management System and continually improve its effectiveness as per requirements of ICH guideline, EU-GMP Guideline and 21 CFR Part 210 and 211 standard.
To implement the QUALITY MANAGEMENT SYSTEM (QMS)
Identifies the processes needed for the QMS. Necessary processes are documented in procedures & work instructions/SOPs.
Determines the sequence & interaction of these processes. This is done by documenting the QMS.
Determine criteria & methods needed to ensure that effective operations & control of these processes. This is done by documenting the QMS.
Ensure the availability of information necessary to support the operation & monitoring of these processes. This is accomplished through management reviews, continual improvement activity & internal audit.
Monitor measure & analyzes these processes. There are documented procedures for management review, training, inspection, customer satisfaction & internal audits.
Implements action necessary to achieve planned results & continual improvement. This is accomplished through management reviews, internal audits & continual improvement activities.
Definition
1) Data Integrity:
Data Integrity refers to the completeness, consistency, and accuracy of Data. Complete, consistent and accurate data should be attributable, legible, contemporaneously recorded, original or a true copy, and accurate.
2) Data:
Information derived or obtained from raw data.
3) Raw Data:
Original records and documentation, retained in the format in which they were originally generated (i.e. paper or electronic), or as a true copy.
4) Meta Data:
Meta data is data that describe the attributes of other data, and provide content and meaning.
5) Original Record:
Data as the file or format in which it was originally generated, preserving the integrity of record, e.g. original paper record of manual observation, or electronic raw data file from a computerized system.
6) True Copy:
An exact verified copy of an original record.
7) Data Life-cycle:
All phases in the life of the data (including raw data) from initial generation and recording through processing use, data retention, archive / retrieval destruction.
8) Primary Record:
The record which takes primary in cases where data that are collected and retained concurrently by more than once method fail to occur.
9) Data governance:
The sum total of arrangements to ensure that data irrespective of the format in which it is generated, is recorded, processed, retained and used to ensure a complete, consistent and accurate record throughout the data life-cycle.
10) Relational database:
A relational database stores different components of associated data and metadata in different places. Each individual record is created and retrieved by compiling the data and metadata for review.
- ALCOA Principle :
This ALCOA is applicable to all form of evidence including electronic, paper-based or hybrid.
It helps in developing strategies so that the integrity of the evidence is maintained both in research & manufacturing.
- Attributable:
This means that the evidence or data collected is attributable to the person collecting it. This ensures accountability. This contains a record of who performed action and when. This could be a paper or electronic record.
A good example of this could be the Finish Sample taken during Packing. These samples are taken for finish analysis as per documented procedure. The person taking the sample should mention the time of taking the samples along with their signature & date. Also, if correction are made to results then the identity & signature of the person who made such corrections should be noted.
- Legible:
The record created, especially the paper-based records should be legible. This is very important in the pharmaceutical industry as a mistaken spelling could result in the administering of a completely different meaning. The records should be permanent and not erasable so that they are reliable throughout the data lifecycle.
- Contemporaneous:
It means that the records should be created at the time of taking the measurement. This includes having time and date stamp on the data and prohibits backdating of data. This is done that continuity is maintained and the results can be viewed with respects to time whenever required.
- Original:
The data should be original in the sense that the medium it is first recorded in should be preserved throughout the lifecycle of the product.
For example, if the data is first collected on paper forms and then digitized, then the paper forms should be kept for the entire lifecycle of the product.
- Accurate:
The recorded data should be accurate, free from errors and biases. No editing should be done on it without making notes of such edits. For example, witness checks are used for critical data collection.
These standards make sure that the data is collected and processed with integrity. ALCOA in pharmaceuticals helps both the companies and the users by making sure there are no record-keeping errors due to which some sub-standard product is released into the market. Therefore, ALCOA is a necessary tool for maintaining quality of Product.
Audit Trial:
Audit Trail means secure, computer-generated, time-stamped electronic records that allows for reconstruction of the course of events relating to the creation, modification or deletion of an electronic record.
An audit trail is a chronology of the “who, what, when, and why” of a record.
For example, the audit trial for a HPLC run could include the user name, date/time of the run, the integration parameters used, and details of reprocessing, if any, including change justification for the reprocessing.
Data Review:
There should be a procedure, which describe the process for the review and approval of data, including raw data. Data review must also include a review of relevant metadata, including audit trial
Data review must be documented.
A procedure should describe the actions to be taken if data review identifies and error or omission.
This procedure should enable data corrections or clarifications to be made in a GMP complaint manner, providing visibility of the original record, and audit trailed traceability of the correction, using ALCOA principles.
Data retention:
Raw data generated in paper format may be retained for example by scanning, providing that there is a process in place to ensure that the copy is verified to ensure its completeness.
Data retention may be classified as archive or backup.
Data and document retention arrangements should ensure the protection of records from deliberate or inadvertent alteration or loss.
Secure controls must be in place to ensure that data integrity of the record throughout the retention period, and validated where appropriate.
Archive:
Long term, permanent retention of completed data and relevant metadata in its final form for the purpose of reconstruction of the process or activity.
Archive records should be locked such that they cannot be altered or deleted without detection and audit trial.
The archive arrangement must be designed to permit recovery and readability of the data and metadata throughout the required retention period.
Backup:
A copy of current data, metadata and system configuration settings maintained for the purpose of disaster recovery.
Backup and recovery processes must be validated.
Training:
Training Shall be imparted for all new documents prepared at facility.
All departmental Head & QA shall be responsible for SOP Training & General GMP training at facility.
Training Evolution shall be done after successful training completion. If anyone will not clear his / her examination then he / she will go under retraining.
Training Records shall be maintained by user department.
Document Generation:
All documents should have a unique identification number (Including the version number) and should be checked, approved, signed and dated.
The use of Uncontrolled documents should be prohibited by local procedures.
The use of temporary recording practices, e.g. scraps of paper should be prohibited.
The document design should provide sufficient space for manual data entries.
The document design should make it clear what data is to be provided in entries.
Documents should be stored in a manner which ensures appropriate versions control.
Master copy (in soft copy) should be prevented from unauthorised or inadvertent changes.
Document Distribution and Control
Updated versions should be distributed in a timely manner.
Obsolete master documents and files should be archived and their access restricted.
Any issued and unused physical documents retrived and destroyed accordingly.
Issue should be controlled by written procedures that include,
- Using of a secure stamp
- Ensuring that only the current approved versions is available for use.
- Allocating a unique identifier to each blank document issued and recording the issue of each document register.
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