I.

RESPONSIBILITY MATRIX

KEY: “Company” = M/s ABC Pharma Ltd “Contractor” = M/s KVS Technologies

Category Responsibility Company Contractor

Compliance with the PLC/SCADA Validation
 
requirements
General To maintain Confidentiality.  
Inspection and approval of Quality Systems and

compliance status of contract acceptor.
Preparation of Protocol for PLC/SCADA validation. 
Execution of PLC/SCADA Validation activities as
 
per the Protocol.
Certification of Reference /standard instrument with

Documentation traceability
Information about any possibility of any hazard
associated with the usage of standard/test 
instrument during Validation.
Verification of Validation Certificates. 
To carry out the PLC/SCADA Validation. 
To provide competent personnel for Validation. 
To take clearance from area in charge for entry and

starting the Validation activity.
Validation
To follow the gowning and entry procedure as

applicable.
Adherence to SOPs 
Supervision of Validation Activity 
Provide testing data and records as requested by

Validati Watson Pharma Pvt. Ltd.
on Maintain the cleanliness of the area /equipment

during Validation activity.
Quality systems Authorization to deviate from PLC/SCADA
validation ,SOP specification through Change 
control management system
Change control /Accuracy/Acceptance Criteria.  

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 Category Responsibility Company Contractor
Modification in the existing equipment, Validation

/Validation criteria of the instrument /Process.
Addition of new equipment and defining the

Validation requirements
Retain records of Validation, traceability certificates. 
Maintain complaint file and response to the

complaints
To assist the investigation for OOS, Deviations and

complaints and submit the report to QA of Watson
Destruction of Obsolete documents after
Destruction authorization of QA.


II. VALIDATION PROCEDURES AND RECORDS

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 a. Contractor must validate in accordance with validation/qualification procedure
which form the part of this agreement.

b. If any parameter in the Validation is altered Or new procedure is introduced, will

be informed to Company and proper approval shall be obtain before executing
the same.

c. Contractor has to prepare validation reports for all the equipments validated as
required by the Company, the original copy of these documents shall be given to
Company.

d. Contractor will carry out test in accordance with procedure specified and agreed
with company. The necessary documents will kept for a period of 3 years from
the date of Validation and validation.

e. If contractor modifies or perform the test according to his own procedure, these
must be approved by Company prior to Implementation.

f. The representation of Company is authorized to cross check the Procedures,

records and inspect the activities of Contractor at any given point of time.

g. The Contractor is responsible for ensuring and handing over the equipments with
validation reports.

III. VALIDATION PERSONNEL

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a. Contractor shall secure adequate personnel to discharge the validation program
duties.

b. Personnel responsible for carrying out any Validation activities must have
adequate training, education thereof, to execute these activities.

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