Standard Operating Procedure (SOP) for Recording Analytical Data

Standard Operating Procedure (SOP) for Calibration of Conductivity/TDS Meter

1. Purpose of Recording Analytical Data

The purpose of this Standard Operating Procedure (SOP) for Recording of Analytical Data is to establish guidelines and procedures for the accurate and consistent recording of analytical data at [Company Name]. This SOP for Recording of Analytical Data ensures that analytical data is recorded, stored, and managed in a manner that meets regulatory requirements and maintains data integrity.

2. Scope of Recording Analytical Data

This SOP for Recording of Analytical Data applies to all personnel responsible for conducting analytical tests, recording data, and managing data records within [Company Name]. It covers the recording of data for various analytical techniques and instruments.

3. Definitions involved in Recording Analytical Data

3.1 Analytical Data:

Data obtained through laboratory analysis, including numerical results, observations, and measurements.

3.2 Data Integrity:

The assurance that data is complete, accurate, and reliable throughout its lifecycle.

3.3 Electronic Records:

Digital records of analytical data, including spreadsheets, databases, and laboratory software.

4. Responsibilities involved in Recording of Analytical Data

4.1. Analysts

4.1.1 Perform analytical tests according to established procedures.

4.1.2 Record analytical data accurately and legibly in laboratory notebooks or electronic systems.

4.2. Quality Control

4.2.1 Oversee and verify the accuracy of recorded data.

4.2.2 Review analytical data for compliance with SOPs and regulatory requirements.

4.3. Data Custodian

4.3.1 Ensure the secure storage and retention of analytical data records.

4.3.2 Control access to electronic records and maintain backups.

5. Data Recording

5.1. Laboratory Notebook

5.1.1 Use bound laboratory notebooks with consecutively numbered pages.

5.1.2 Record analytical data directly in the laboratory notebook in a legible and permanent manner.

5.2. Electronic Records

5.2.1 Use validated laboratory software or electronic systems for data recording and storage.

5.2.2 Ensure electronic records are backed up regularly and protected against unauthorized access.

5.3. Data Fields

5.3.1 Include the following information in each recorded data entry:

  • Date and time of analysis
  • Sample identification or batch number
  • Test method used
  • Instrument or equipment used
  • Raw data, observations, and calculations
  • Analyst’s initials or electronic signature

6. Review and Verification

6.1. Data Review

6.1.1 Analysts and quality control personnel must review recorded data for accuracy and completeness.

6.1.2 Any discrepancies or errors should be documented and corrected.

6.2. Electronic Data Verification

6.2.1 Electronic data should be protected from unauthorized changes or deletions.

6.2.2 Implement electronic audit trails to track changes and data access.

7. Data Retention and Archiving

7.1. Laboratory Notebooks

7.1.1 Laboratory notebooks should be kept for a minimum period of [Specify duration] and stored securely.

7.1.2 Obsolete laboratory notebooks should be properly archived or disposed of according to company policies.

7.2. Electronic Records

7.2.1 Maintain electronic records according to regulatory requirements and company policies.

7.2.2 Ensure regular backups and disaster recovery plans are in place for electronic data.

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Pharmacareer team is a team of Experts from every department of Pharmaceutical industry having enriched experience. Experts have work experience of many multinational pharmaceutical industries worldwide.

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