Validation

PKMP System Verification and Validation Process.

System verification and validation testing is performed on the PKMP application every time a new release is pushed into the production. PKMP team follows a monthly release plan. As part of release planning new features and bug fixes are short-listed to be part of a new release. PKMP testing team has developed an elaborate plan covering the verification and validation testing of the PKMP application. The plan includes more than 1000 test cases across all PKMP modules covering testing of possible use-cases and different scenarios. Based on the changes planned for a new release the verification and validation plan document is updated covering testing of changes and new features or modules added as part of the release. A new version of System verification and validation plan report is generated by test team as part of every new release. Only after the successful testing of the changes and new features a new release is approved to be pushed into production.

Primary input to the System validation and verification testing is the system requirements and the design specification documents for the PKMP application modules and features. To ensure each system requirement is implemented and as per the design specifications a traceability matrix is created linking system requirements, design specification and system verification and validation test plans.

For additional information on validation please see the attachment.  PKMP SVVR

An example of validation of PKMP

Data uploaded as per the original user data set with matching headers and values to confirm the integrity of uploaded data set.

Time	Subject	Treatment	Period	Sequence	Dose	Cp
0	1	A	2	BA	100	0
1	1	A	2	BA		255
2	1	A	2	BA		447
3	1	A	2	BA		449
4	1	A	2	BA		410
6	1	A	2	BA		226
Additional data up to 72 hours
0	1	B	1	BA	100	0
1	1	B	1	BA		1.84
2	1	B	1	BA		257
3	1	B	1	BA		437
4	1	B	1	BA		432
6	1	B	1	BA		276
Additional data up to 72 hours

The analysis of the data set with published known analysis and the PKMP parameters were tested and verified across the module. The following is an example of comparison of pharmacokinetic parameters as a part of validation of PKMP.

Standard – Known analysis
Subject	Treatment	Period	Sequence	Dose	Kel	Cmax	AUC(0-t)	AUC(0-inf)
1	A	2	BA	100	0.048	449	4215	4286
1	B	1	BA	100	0.046	437	3814	3893
PKMP analysis
Subject	Treatment	Period	Sequence	Dose	Kel	Cmax	AUC(0-t)	AUC(0-inf)
1	A	2	BA	100	0.048	449	4215	4286
1	B	1	BA	100	0.046	437	3814	3893