Metrohm TiNet 2.5 - Manual (Page 29)

TiNet 2.5 Compliant Methods • 27
4. Methods
4.1 General information on methods
Two different types of methods are used in TiNet 2.5 Compliant: Draft
methods and Database methods.
4.1.1 Draft methods
Draft methods are stored as files in the Methods directory. Only these
methods can be edited in the TiNet 2.5 – Methods program part. If the Use
signed methods only
option is disabled, draft methods can also be used to
perform determinations. In this case, the requirements for working accord-
ing to 21 CFR Part 11 are not met.
You will find detailed information on edition of draft methods in the
8.110.8243 Instructions for Use "TiNet 2.4/2.5", section 6.
Note:
Start and end sequences are ignored with TiNet 2.5 Compliant.
4.1.2 Database methods
Draft methods can be saved in the method database as Database meth-
ods. At every saving procedure, a new method version is created. The
user must enter a comment for each method version. In order to use da-
tabase methods they must be signed electronically and given a signature
comment. In addition to this, the
Use signed methods only option must be
enabled. If you use database methods, the requirements for working ac-
cording to 21 CFR Part 11 are met.
A method version of the method database must be copied as draft
method before it can be edited. If already present, an existing draft
method with the same name is overwritten. Once the method has been
modified, it must be saved again in the method database as a new
method version.
You will find detailed information on edition of draft methods in the
8.110.8243 Instructions for Use "TiNet 2.4/2.5", section 6.