All
over the world it is easily observed that vendors
who have computerized their facilities and moved on
to e-communications and e-submissions are shown greater
preference by the primary manufacturers, compared
to those who lag on this front. However, since computerization
does not necessarily imply 'tamper proofing', the
manufacturers and in fact the FDAs of different countries
insist on compliance to regulations that would help
ensure the same. Typical standards include those of
21CFR11, GAMP V, PICS, etc.
Thus
there is a strong tendency to ensure such compliances
and have the same validated by independent auditors.
DSSPL has the necessary staff who have excellent
exposure to software, automation, pharmaceutical
R&D, production, regulatory practices and audits,
etc., who can perform such independent validations
of your automation and software and provide a detailed
report, acceptable to the FDA.
