Standard Operating Procedure

Identification and Control of Laboratory Records

This is an example of a Standard Operating Procedure. It is a proposal and starting point only. The type and extent of documentation depends on the process environment. The proposed documentation should be adapted accordingly and should be based on individual risk assessments. There is no guarantee that this document will pass a regulatory inspection.

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STANDARD OPERATING PROCEDURE Document Number: S-526 Version Beta

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Identification and Control of Laboratory Records

Company Name:

Controls: Superseded Document Reason for Revision Effective Date Signatures: Author I indicate that I have authored or updated this SOP according to applicable business requirements and our company procedure: Preparing and Updating Standard Operating Procedures. Name: Signature: Date: Approver ________________________________ ________________________________ ________________________________ N/A, new N/A March 1, 2008

I indicate that I have reviewed this SOP, and find it meets all applicable business requirements and that it reflects the procedure described. I approve it for use. Name: Signature: Date: ________________________________ ________________________________ ________________________________

Reviewer

I indicate that I have reviewed this SOP and find that it meets all applicable quality requirements and company standards. I approve it for use. Name: Signature: Date: ________________________________ ________________________________ ________________________________

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STANDARD OPERATING PROCEDURE Document Number: S-526 Version Beta

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Identification and Control of Laboratory Records

1. PURPOSE
ISO 17025 equivalent standards require records to be accurately recorded, identified and controlled throughout their lifetime such that data integrity and traceability is ensured. This SOP defines steps to identify, record, change, archive and retrieve records.

2. SCOPE
The SOP applies to laboratories operating under ISO 17025 and equivalent quality systems. The SOP applies to original and processes records and to supporting material such s chromatograms and spectrograms. The SOP applies to handwritten records, data entered into a computer system and electronic records acquired from an automated system.

3. GLOSSARY/DEFINITIONS
Item QA Explanation Quality Assurance

Note: For other definitions, see www.labcompliance.com/glossary.

4. REFERENCE DOCUMENTS
4.1. ISO 17025, General Requirements for Competence of Testing and Calibration

Laboratories, 2005

5. RESPONSIBILITIES
5.1. Recorders

Comply with this SOP.

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Identification and Control of Laboratory Records

5.2. QA

Use proper and approved forms and worksheets Secure records when in their possession

Verifies that users comply with this SOP

5.3. Supervisors

Verify adequacy and accuracy of forms and worksheets in their area Review report packets for completeness

5.4. Management

Ensures that staff is trained to comply with this SOP. Ensures that staff have adequate tools to comply with this SOP, e.g., record management system and validated software with adequate functions to ensure authenticity and integrity of electronic records.

5.5. Record manager

Maintains record system and data bases Archives and disposes records according to company policy

6. FREQUENCY OF USE
The SOP is used whenever records are generated, recorded, changed and archived.

7. PROCEDURE
7.1. The record manager maintains with different types of records

Examples are Reports Correspondence Diaries

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Identification and Control of Laboratory Records Environmental monitoring records. Instrument calibration records. Handwritten transcriptions to paper records of information displayed on digital equipment, e.g., balances. HPLC chromatograms and report tables. Documents relating to evaluation and interpretation of data. Internal audit reports Management reviews Corrective and preventive actions Forms Work sheets Control graphs Inspection reports Test reports

7.2. Identification of records

Records are identifiable to the type of work and type of records to which they pertain Records are dated and identify the person who established the record

7.3. Recording through Handwriting and Error Correction

7.3.1. The original recording of information on paper constitutes the original records which must be retained. Any subsequent transcription of this information will not substitute the originally recorded information. 7.3.2. Records contain the date and initials or signature of persons performing the work 7.3.3. Entries are made in durable blue or black ink. 7.3.4. Spaces not used will be indicated with a line 7.3.5. All errors are corrected using single-line error cross out. Each correction is dated, initialed and annotated.

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Identification and Control of Laboratory Records 7.3.6. Data or information is not discarded without explanation. To discard, the data or information is crossed out, initialed, dated and the reason for discarding indicated.
7.4. Entries into Electronic Notebooks or other Electronic Systems When original raw data are keyed into an electronic system;

7.4.1. The system should comply with good Electronic Record keeping Practices. For example: The system should be validated. The system should only accept data from users with access rights. The system should identify and record the user. Electronic records should be linked to the user. The system should have provisions to ensure integrity of data, for example, through an independent electronic audit trail that independently records who has changed what and when.

7.4.2. The software should check plausibility of data entries. 7.4.3. Back-ups of electronic records should be performed regularly, e.g., daily, weekly or monthly. The back-up process should be validated.
7.5. Copying Records

7.5.1. Records can be copied to the same or other media and the original record can be deleted. For example: Instable thermo paper to durable normal paper. Scans of paper records to electronic records. Photocopying of paper records to microfiches. Copying electronic records to another media, e.g., hard disk to tape or CD/DVD.

7.5.2. Each copy process in7.5.1 should be validated and controlled to ensure that each copy is accurate and complete.
7.6. Transcription of Paper Records into a Computer Database

If original records are transcribed to a computer database, neither the electronically stored data nor its paper printout can substitute the original.
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Identification and Control of Laboratory Records

7.7. Electronic Data Capture from Equipment

When original records are automatically captured by an electronic system; 7.7.1. The system should comply with Good Computer Pracices. For example: The system should be validated. The system should only accept data from users with access rights. The system should identify and record the user. The system should identify and record the automated equipment. Electronic records should be linked to the user.

If users have access to the raw data and can change the raw data the system should have provisions to ensure integrity of raw data, for example, through an independent electronic audit trail that independently records who has changed what and when. 7.7.2. The user may elect to treat the electronically recorded information or the hard copy printout of information as original record. If the printed copy is elected as the original record users should ensure that the paper copy preserves the content and meaning of the electronic record and the paper copy is sufficient to demonstrate compliance with ISO 17025 or equivalent standards. The decision to delete the original record should be justified and documented.
7.8. Security and Access

Records should be secured in rooms at all times. There should be restricted and authorized access to all records to prevent unauthorized use and unauthorized changes Records should returned during normal business hours to principle custodian

7.9. Filing and Storage

Records should be stored in dry and clean rooms. Storage areas and cabinets should be labeled. Records and other quality documents may not be stored in private desk drawers or other locations that are not generally accessible
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Identification and Control of Laboratory Records

7.10. Record Retention and Archiving

The record manager maintains a list with the retention period for each type of document. The list has been generated to conform with internal and external record keeping standards and regulations. The form in Attachment 8.1 should be used to generate the list. Records should be archived in dry and clean rooms to ensure the integrity of records Records should be archived in secure locations with limited and authorized access . If an off-site area is used to archive documents the on-site archives should contain specific reference to the materials that are stored off-site and to the location

7.11. Disposal

After the retention period is completed records should be destroyed. .

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Identification and Control of Laboratory Records

8. ATTACHMENTS
8.1. Attachment Type of Records with Required Retention Period and Retention

Media

Type of Record

Total Retention Period

Retention Media

Comments

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