Purified water Phase-III Validation

After Modification as discribe below Requalification of water system is required ???

Kindly give the guidance for occure the related problem…


Purified water generation system (SBM Block)

Purified water generation system validation Phase-I and Phase-II completed on 17/07/13 and Phase-III validation started on 18/07/13 and to be completed on 18/07/14.
During Phase-III validation 18/07/13 to 21/03/14 Purified water system working observed as per Operating parameters and all the results of generation system complies as per specification.
EDI outlet (Purified water generation point) conductivity was increased continuously and observed out of specification from 22/03/14 to 01/05/14. During investigation it was found that dissolved silica (SiO2) level increase in Source water( River water) . When EDI outlet conductivity beyond the set limit water
gets recirculate in Multipurpose tank to EDI and when conductivity within the set limit purified water is stored in SS storage tank which distributes the purified water through user points in facility.
Modification will be taken as additional RO to be installed in post Pretreatment system to reduce the dissolved silica level.
Will it impact the Purified water generation system Phase-III validation ? Is Phase-III validation required to discontinue from date 22/03/14 ? Shall requalification required for Purified water generation system…? (after modification of additional RO in Pretreatment system).

Kindly revert back…
Thank you…

My opinion is yes.You need to perform full requalification of your equipment with change control protocols.