1.1 To maintain the raw data and other records in a sophisticated manner.
2.0 SCOPE
2.1 This SOP is applicable to all the personnel working in Company.
3.0 RESPONSIBILITY:
2.0 SCOPE
2.1 This SOP is applicable to all the personnel working in Company.
3.0 RESPONSIBILITY:
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All personnel working in Company are responsible for the implementation of this SOP.
4.0 DISTRIBUTION
4.1 The quality assurance department responsible to keep all SOPs ‘Master Copy’ approved through the Quality Manager.
4.2 The copy of ‘Control Copy’ of all SOPs are being distributed in all user departments and placed near related Equipment/ Instrument.
5. 0 DEFINITIONS &ABBREVIATIONS :
5. 1 ABBREVIATIONS :
SOP: Standard Operating Procedures
QA: Quality Assurance
QC: Quality Control
QC: Quality Control
5.2 DEFINITIONS:
Raw Data: Any laboratory datasheets, records, memoranda, notes, or exact copies that are the result of original observations and activities of a study and are necessary for the reconstruction and evaluation of the report of that study. Raw data may include photographs, computer printouts, and recorded data from automated instrument.
6.0 PROCEDURE
6.1 Good Documentation Standards
6.1.1 Documentation and raw data must stand alone and require no verbal explanation.
6.1.2 Testing/research activities must be able to be reconstructed from the raw data only by someone other than the scientist performing the activity.
6.1.3The following information should be documented during all testing/research activities:
6.1.4What and when the activity was performed.
6.1.5 The procedures, events, and results.
6.1.7 Any observations, data, etc., needed for reconstruction.
6.1.7 All titles and headers needed to identify the document.
6.1.8 Signatures/initials and dates of those collecting and analyzing the data. Do not pre-date or post-date data; initial and date on the day of entry.
6.2 Document and Records Management
6.2.1 The PI is responsible for delegating authority for the development of documents and records, as well as providing a timeframe in which to start and complete the document.
The Quality Manager works in conjunction with the PI to determine document format, scope, audience, length, etc. The Quality Manager also provides a specific document code to a specific document.
6.2.2 Once complete, the quality Manager is responsible for distributing the document to the PI, and other senior research personnel (if required) for review. She/he is also responsible for maintaining a master version of the document. Once complete, the final version of the document is also saved in the appropriate subfolder.
6.3 Maintenance
6.3.1 The Quality Manager is responsible for maintaining on file and on the matrix of all documents and records. The matrix includes the following headings: document type (i.e., SOP, QA ,QC, findings report, form, etc), document code, title, manager, status and date.
6.3.2 The Quality Manager is also responsible for maintaining all documents and records for a period of one year. Soft copy versions of all documents and records must be saved to the personnel computers. Hard copies of documents and records, including raw data, are scanned and also saved.
6.3.3 Due care and diligence are taken to properly dispose of documents and records that are no longer required after the one year period has lapsed. Disposal procedures involve electronic deletion of documents and records from the personal computers as well as manual shredding of hard copies.
7.0 PRECAUTIONS
Not Applicable
8.0 REFERENCES & FORMATS :
8.1 REFERENCES:
In house
8.2 FORMATS
9.0 REVISION HISTORY
9.1 Maintain the history of SOP or document as per the format given in Format-X. It shall be maintained along with the current version of the SOP.
END OF THE DOCUMENT
Raw Data: Any laboratory datasheets, records, memoranda, notes, or exact copies that are the result of original observations and activities of a study and are necessary for the reconstruction and evaluation of the report of that study. Raw data may include photographs, computer printouts, and recorded data from automated instrument.
6.0 PROCEDURE
6.1 Good Documentation Standards
6.1.1 Documentation and raw data must stand alone and require no verbal explanation.
6.1.2 Testing/research activities must be able to be reconstructed from the raw data only by someone other than the scientist performing the activity.
6.1.3The following information should be documented during all testing/research activities:
6.1.4What and when the activity was performed.
6.1.5 The procedures, events, and results.
6.1.7 Any observations, data, etc., needed for reconstruction.
6.1.7 All titles and headers needed to identify the document.
6.1.8 Signatures/initials and dates of those collecting and analyzing the data. Do not pre-date or post-date data; initial and date on the day of entry.
6.2 Document and Records Management
6.2.1 The PI is responsible for delegating authority for the development of documents and records, as well as providing a timeframe in which to start and complete the document.
The Quality Manager works in conjunction with the PI to determine document format, scope, audience, length, etc. The Quality Manager also provides a specific document code to a specific document.
6.2.2 Once complete, the quality Manager is responsible for distributing the document to the PI, and other senior research personnel (if required) for review. She/he is also responsible for maintaining a master version of the document. Once complete, the final version of the document is also saved in the appropriate subfolder.
6.3 Maintenance
6.3.1 The Quality Manager is responsible for maintaining on file and on the matrix of all documents and records. The matrix includes the following headings: document type (i.e., SOP, QA ,QC, findings report, form, etc), document code, title, manager, status and date.
6.3.2 The Quality Manager is also responsible for maintaining all documents and records for a period of one year. Soft copy versions of all documents and records must be saved to the personnel computers. Hard copies of documents and records, including raw data, are scanned and also saved.
6.3.3 Due care and diligence are taken to properly dispose of documents and records that are no longer required after the one year period has lapsed. Disposal procedures involve electronic deletion of documents and records from the personal computers as well as manual shredding of hard copies.
7.0 PRECAUTIONS
Not Applicable
8.0 REFERENCES & FORMATS :
8.1 REFERENCES:
In house
8.2 FORMATS
9.0 REVISION HISTORY
9.1 Maintain the history of SOP or document as per the format given in Format-X. It shall be maintained along with the current version of the SOP.
END OF THE DOCUMENT
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