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We use an efficient systematic approach to protocol development which allows for the preparation of the documentation in the shortest time possible. We also employ a pragmatic, common sense, approach to protocol execution which allows us to fulfill all regulatory requirements efficiently with a minimum of delay and with a minimum of interference with operations.
GAMP5... [more info]
Auditing Services... [more info]
Quality Plans.... [more info]
Validation Master Plans... [more info]
IQ Protocol Generation & Implementation.... [more info]
OQ Protocol Generation & Implementation.... [more info]
PQ Protocol Generation & Implementation.... [more info]
Summary Reports... [more info]
Computer System Validation... [more info]
Project Management.... [more info]
SAT Generation & Implementation.... [more info]
FAT Generation & Implementation.... [more info]
SOP Development & Review.... [more info]
Equipment/Process Specification
URS Generation.... [more info]
FRS Generation.... [more info]
DDS Generation.... [more info]
cGMP Training Courses.... [more info]
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News, Events, Validation Master Plans, IQ, OQ, PQ, 21 CFR Part 11 gap analysis, Summary Reports, CSV, GXP, GMP, cGMP, GAMP5, SOP’s, URS, FRS, URS and DDS Generation for all packaging and processing equipment
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