Good Validation Service
that means:

Validation Consulting for compliance with FDA 21 CFR Part 11!!!

We operate according to a Validation Master Plan, which follows the logical V Model representing the Software Development Life Cycle (SDLC)

The steps can also be described according to the 4 Q model:

 DQ Design Qualification (left wing)

 IQ Installation Qualification (right wing)

 OQ Operation Qualification (right wing)

 PQ Performance Qualification (right wing)


Additionally Change Control Management and Maintenance Procedures must be installed while using the software in practice.

Logical model means: the V Model will be followed during the validation process according to the corresponding logical steps, which will be pre-defined in the Validation Master Plan. The real validation process can absolutely be different, according to the status of the project, the different steps may require different amounts, OQ and PQ will be merging or may be nearly identical or indistinguishable etc. This depends also on the type of validation, whether it is a new one, the x-fold re-validation or a retrospective validation of a legacy system.

Very important note: it is possible to go back in the left, descendant wing of the V at any stage, if quality control results in failure or non-compliance with the specification. In the right, ascending wing of the V this is impossible, because the test will be made against the specifications parallel to the other wing on each

step. If the test specifications will not be met one must go to the left and must start again from this step!


Good Validation Service includes:

 Preparation of Validation Master Plans (S/W & H/W under GMP, GLP and GCP conditions, analytical methods, machine processes etc.)

 Preparation of SOPs

 Design of specifications

 Definition of infrastructural requirements

 Development of tests scenarios and test scripts

 Preparation, compiling, and completing of validation documentation

 Review of validation documents

 Audit of validation processes

 Design of User Acceptance Tests

 Preparation of Validation Summary Reports

 Documentation of computer network architecture with software tools


and many more!

ENCRYPTION

Beyond that we offer consulting in encryption processes (Pretty Good Privacy, PGP):

 Encryption of confidential documents/files

 Authentication and Integrity of documents using a digital signature

The public key of PMK is as follows::

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Version: PGP 8.0 - not licensed for commercial use: www.pgp.com

mmQGiBD5WJPwRBAD0brgEpTH+aqr3feP5j/XA7Fh3SklRV2h2JQ7aweHO6PBmokxb
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/8w96toggCfaTcDQbg9RbYWmsV3js12In9Kw0MAoJWvwY4zD5LNyG/8ecjONBED
dMEE
=a80D

-----END PGP PUBLIC KEY BLOCK-----