Elsanhouty Pharma Notes, Cairo , Egypt.

Standard Operating Procedure

Title: SOP for Data Integrity

1. Data :
1.1. Data is facts, figures, and statistics recorded or generated (collected) during the GXP activity. Data
includes all original records, true copies, source data, metadata, reports which are record during the
GXP activity. Data should follow the ALCOA+ principle i.e. Attributable, Legible,
Contemporaneous, Original, Accurate, Available, Enduring, Complete, and Consistent.

2. ALCOA represents the

 Terms Attributable, Legible, Contemporaneous, Original, And Accurate. But now, ALCOA is
outdated and ALCOA+ is the updated concept. It’s just like GMP to cGMP.
 This “+” represents Available, Enduring, Complete, Consistent.
 This “+” also indicates that in the future new terms will be added and as part of ALCOA.
 Many of Pharma industry and regulatory bodies like FDA, WHO follow this concept.
3. Types of data
3.1. Raw data
3.1.1. It is the original record which captured the first time either electronically or recorded on paper
(manually). In the case of balance, pH meter instrument data do not store electronically they
provide printed data output that time printed data consider as raw data.
3.1.2. Complete record in the form of laboratory worksheet, records, notes, memoranda, microfilms,
photographs, computer printouts, magnetic media, dictated observation, recorded data from
automated instruments also consider raw data.

1
Dr. Hassan Elsanhouty
3.2. Source data
3.2.1. This terminology is used for clinical investigation purposes. Source data is the same as raw data
(laboratory investigation purpose). Source data include original records of clinical observation and
investigation. Source data review by both sponsor and FDA for safety, quality, and integrity
(ALCOA+).
3.3. Meta data
3.3.1. Data which indicates attributes (Specialty) of other data and gives reference and meaning of that
other data. Contextual information required to understand data. Metadata described as data about
data. The audit trail is considered as metadata. Data that automatically generated by the original
data source also consider as metadata.
3.4. Audit trial
3.4.1. Form of metadata having information about creation, alteration, or deletion of GXP record. This
secure recording of product details during the manufacturing life cycle.
3.4.2. This is the medium includes who, what, when, why chronologically the action performed.
3.4.3. The computerized system responsible for the generation of raw data always links with an audit trail
to identify the alteration, deletion, or any changes in data by retaining both altered data and original
data.
3.4.4. An audit trail is secure, computer-generated data the audit trail should always switch on.
3.4.5. Only administrators having the right to switch off audit trail and the record retains of that activity ,
Audit trial should review as relevant data if any abnormality found during reviewing audit trial, an
investigation is required.
4. List of Data Generated in pharma industry but not be limited
4.1. Batch Manufacturing Record (BMR)
4.2. Batch Packing Record ( BPR)
4.3. Training Record
4.4. Laboratory test report (In process/Finished Product)
4.5. Out of Specification (OOS)
4.6. Out of Trend (OOT)
4.7. Deviation
4.8. Change Control
4.9. Market Complaint
4.10. Product Recall
4.11. Validation (Analytical/Process/Equipment /Cleaning)
4.12. Stability record
4.13. Logbooks

2
Dr. Hassan Elsanhouty
4.14. Returned good
4.15. Job description of the employee
4.16. Attendance of employee
4.17. Health checkup
4.18. Work orders
4.19. Preventive maintenance
4.20. Internal / External Audit
4.21. Audit compliance
4.22. Annual Product Quality Review (APQR) / Annual Product Review (APR)
4.23. Approved vendor documents.
5. Attributable
5.1. Clearly indicates who recorded the data / performed the activity with sign data
(manually/electronically). Record who wrote it and when. FDA requirement is data should be trace or
link with its source like study, analytical run, test system, etc. This concept is applicable for original
data as well as any change in data both should be sign and date by an individual.
6. Legible (Readable)
6.1. Data should be readable after it is recorded. Data is recorded permanently in a long-lasting (durable)
medium like a pen, non-removable ink. This is applicable for both printed and handwritten documents.
7. Contemporaneous (Online Record)
7.1. Record the data at the time it was generated i.e. contemporaneously. It is well known online recording
of data. If more promptly (no delay) data is recorded, better the quality. The date of data entry should
be required.
8. Original
8.1. Prevent data in its unaltered state like raw data, source data. This is the first data generated
electronically or manually.
9. Accurate
9.1. Data reflect its actual value / trueness, free from error. Accuracy of data indicates quality.
10. Available
10.1. Data should be available for review at any time until the defined storage of the document. Available at
the time of audit and whenever required for review.
11. Enduring
11.1. Making sure records exist for the entire period and readable condition.
12. Complete
12.1. Data must be incomplete state to avoid recreation/ manipulation. The required level of details fulfills in
the documents consider as complete. Complete records show its data reliability and quality.

3
Dr. Hassan Elsanhouty
13. Consistent
13.1. Good Documentation Practices should be applied throughout any process for consistency in
documentation. Available data should be in a sequential manner with a sign and date. Time should be
in the correct sequence to show the reliability and consistency in the process and activity performed.

4
Dr. Hassan Elsanhouty