by VALIDATION OF SPREADSHEET CONTROL AND ACCURACY OF RESULT
| Product Name | : | NA |
| Study | : | SPREADSHEET VALIDATION |
| Protocol No. & Revision No. | Effective date | Reason |
| New Document |
Table of contents :
| Sr. No. | Subject | Page No. |
| Protocol Approval | ||
| Objective | ||
| Scope | ||
| Responsibility | ||
| Verification Team | ||
| Verification procedure | ||
| Change management | ||
| Acceptance criteria verification check | ||
- Protocol Approval:
Prepared By:
| Functional Area | Name | Designation | Signature / Date |
| Quality Control |
Reviewed By:
| Functional Area | Name | Designation | Signature / Date |
| Quality Assurance | |||
| Head Quality Control |
Approved By:
| Functional Area | Name | Designation | Signature / Date |
| Head QA |
- Objective:
Microsoft excels worksheet shall be used in testing laboratory for the purpose of calculation of assay, dissolution. Dissolution profile, blend uniformity, content uniformity and average, SD and RSD% using input values in their corresponding formulae. To avoid inadvertent or accidental alteration, deletion of data or formula, there is a need to ensure the security and integrity of these worksheets. This shall require verification of the security at the level of workbook and worksheets as well as accuracy of calculation.
- Scope :
The spreadsheet shall be verifying for its ability to calculate the % assay, dissolution, dissolution profile, blend uniformity, content uniformity and average, SD and RSD%. The calculation shall be performed using spreadsheet or excel to be used in quality control laboratory.
- Responsibility of Team:
| Departments | Responsibilities |
| QC | Preparation & Review of Protocol. |
| Performing activity and checking of data | |
| Preparation of report | |
| To impart training of protocol to concerned department/persons. | |
| IT Person | IT person is responsible for implementation of system security, data compilation and review of protocol as well report. |
| QA | Review and approval of protocol. |
| Co-ordination with QC to carry out the activity | |
| Approval of protocol and report |
- Verification Team:
Officer/ Executive- Quality Control
Manager- Quality Control
Info tech person- IT department
Head- Quality Assurance
- Verification Procedure:
The excel calculation sheet should be verified as outlined in the SOP for the ‘Preparation, verification of spreadsheet control, accuracy and usage of spreadsheet’ used in the analytical calculation.
Implement the excel calculation sheet which is prepared. based on the calculation methodology as mention in the respective standard test procedure for assay, dissolution, dissolution profile, blend uniformity, content uniformity and average, SD and RSD%.
- Excel calculation sheet design:
It is important to protect the excel calculation sheet from inadvertent changes to verify the reliability of the excel calculation sheet by comparison with known results from the known data and to ensure that the excel calculation sheet can handle unforeseen data input needs.
Ensure the excel calculation sheet in such a manner that data can only be entered in the unprotected cells.
Ensure all cells of excel calculation sheet are locked except those needed by the user to input data.
Ensure the cells containing formula for calculation are protected and remain constant with administrator password.
Ensure excel calculation sheet read-only with password protection. So that only authorized users can use the excel calculation sheet.
Ensure that data entry is secured by error messages.
Ensure that changes like alteration in the protected cells inserting rows or columns are not possible.
Ensure that excel calculation sheet read on only template should be retained in a secure location in an electronic from with access control.
IT person ensure the protected cells, where no variables/ reading needs to be entered or where formula has been created for calculation of results by giving a password.
Attached the screen shot along with the verification report.
IR person should ensure that excel worksheet shall be avaliable to the users in a separate folder on server having path………………………………………………..
- Validation:
Availability of validated excel calculation sheet:
Acceptance Criteria: Excel calculation sheet shall be available on a separate folder.
Wrong password: An attempt shall be made to alter the contents of protected cells carrying the formula and fixed contents.
Acceptance Criteria: The excel calculation sheet shall not open with the wrong password and the system shall display the message accordingly. The screen print carrying the system message shall be printed and attached.
Alteration: An Attempt shall be made to alter the contents of the protected cells carry the formula and fixed contents.
Acceptance Criteria: The excel calculation sheet not added or delete the row/column and the system shall display the message accordingly. The screen print carrying the system message shall be printed and attached.
Addition or deletion of row /column: An Attempt shall be made to add or delete row/column.
Acceptance Criteria: The excel calculation sheet not add or deleted the row/column and the system.
