Test tool validation sop

For all new instruments, calibrate the instrument more frequently once in three months for a year followed by once in six months , and for existing instruments follow SOP for Calibration. Follow the procedure for allocation for testing. Make an entry for all the calibrations due in the month. Read the relevant SOP and organize the work in such a manner that testing can be completed in the allotted time. Carry out the calibration and checks as given in the relevant SOP unless otherwise advised by the section head.

Short Description of the process. Summary of the critical processing steps with operational parameters to be investigated Experimental plan and limits. Finished product specifications for release. List of analytical methods, as appropriate. Proposed in-process controls with acceptance criteria. Additional testing shall be carried out if any , with acceptance criteria and analytical validation, as per requirement and necessity. Data Accuracy testing to ensure that the provided data is correct.

Data Completeness testing to check whether the data is complete or not. To verify that the provided data go successfully through transformations or not is by Data Transformation Testing. Data Quality testing to handle bad data. Database comparison testing to compare the source DB and target DB. End to End testing. Data warehouse testing.

Many organizations are moving into modern DevOps practices, also investing in building new projects into Microservice-based architecture. It is highly recommended to analyze the data to understand the requirement which is a need for business purposes.

Handle bad data correctly. Use of the particular tool which fits perfectly between source and target. Firstly, test on sample data instead of full complete data. This process will save time as well as resources also.

Compare the output result with the expected. Validation Team Leader iii. Validation Officer iv. Representative of Production Department v. Analyst vi. Microbiologist 5. Validation programs should be continued through full-scale commercial production.

This concept involves cleaning, sampling and testing with repetition of this sequence until an acceptable residue limit is attained. A validation program generally encompasses at least three consecutive successful replicate to establish that the procedure is reproducibly effective. If the equipment of the similar size, design and construction is cleaned by the same procedure, studies need not be conducted on each unit as long as a total of three successful replicates are done on a similar piece of equipment; this concept is known as equipment grouping.

Changing in Machine ii. Change in cleaning agents used if applicable iii. Change in cleaning procedures If any of the above-cited changes are required it should be performed in accordance with the change control procedure SOP No.

After the approval of any change according to the procedure, it is required to revalidate the Cleaning Procedure. Testing Parameter.

Acceptance Criteria. Physical determination.