Please suggest strategy to validate existing CSystems/softwares for laboratory.
This question does not make sense and is too broad to answer.
We are actually setting up new pharmaceutical laboratory with equipments like HPLC, GC, UV, IR which involve use of software for generation of results which are printed on paper to produce final certificate of analysis. Raw data obtained from the software is fed into the excel spreadsheet to generate final results. Please suggest how to proceed for compliance to 21 CFR part 11. Hope I am elaborate this time.
First of all have you got a master validation plan on-site which deals with how you proceed with Software Validation?
thanks for reply.
We have got VMP which includes portion dealing with computer system validation but it is not very much elaborate in terms of defining how to proceed with software validation so can you please help in this regard.
I think we first need to divide our approach for validation. We can divide this as following:
i) Equipment Validation-PLC, SCADA,BMS, ii) Standalone Laboratory Systems (Softwares) validation-UV, FTNIR-AIRS, XRD, Data Loggers iii)Networked Enterprise Systems- Empower Systems, Attendance Recording Systems, Access Controllers, Wi-Fi Validation, Network Qualification and there can be many more things for GMP and GLP.
For all above systems, the very first thing is to create Validation Master Plan (VMP) or Project Validation Plan (PVP), which behaves as the bible for the whole project. PVP will consists of the Scope, Objectives, Responsible Persons for executing this project, Qualification Strategy, Validation Deliverables which will be based on the SDLC lifecycle phases. For compliance, we should follow the documentation according to SDLC lifecycle phases and the documents must be approved phase wise.
Now coming to your question, for compliance, Requirements should be covered in URS and then a Qualification plan (QP) should be developed based on whic we should execute certain test scripts as an IQ, OQ and PQ, where we can challenged the URS in the PQ. Taking an example of UV, where you calculate the absorbance of the sample, transmittance of the sample and check the correctness of the sample. We create Method in the form of photometric and Spectrum to perform the analysis. Following verification should be done in order to maintain compliance.
- System Should have abilitiy to Print/Review/Process data from the system
- System should be ability to calculate and display the absorbance /Transmittance of the sample to be analysed using the desired method
- The system should be allow to record the audit trail of all activity perform through the application software in Operation Mode.
- All the analysis data including audit trail should be stored in the system.
- The report can be exported from the system, in order to archive it for future requirements
- Access to the system should be controlled through user id and passwords.
- Check for User/Role Authorzation
I believe this explanation may help a bit for setting up your lab instruments or softwares.
Thanks Sour for your guidance on this issue…it was really very helpful!!!
You are welcome Rave and I will be happy to help you further clarifying your doubts…