Six of Wands Consultants

Six of Wands provides the following consultancy services to the pharmaceutical industry:

If you require more specific information about our services or would like to arrange a meeting please email us.

Regulatory Publishing

We are experienced in the use of electronic publishing tools such as Liquent’s EZsubs to compile Clinical Study Reports and regulatory submissions. We can help with:

· Setting up skeleton structures for Clinical Study Reports and submissions, for example using virtual document structures.

· Checking and editing documents to comply with overarching SOPs and authoring requirements.

· Populating structures with authored documents.

· Publishing reports and submissions to a set of paper volumes or as an electronic file hierarchy.

· Writing user documentation such as Style Guides for authors that will ensure your documents are produced in a publishable format.

Computer Systems Validation

The validation of computerized systems such as electronic publishing tools often causes a headache. Let us ease your pain! We can offer the following services in accordance with Good Automated Manufacturing Process (GAMP4):

· review your User Requirements Specification and advise on whether the document is a good starting point for the validation process.

· construct a Validation Plan that details your validation activities.

· help you to formulate a Functional Requirements Specification, Criticality Analysis and Traceability Matrix.

· help with writing scripts for and performing the Installation Qualification, Operational Qualification and Performance Qualification in accordance with your validation documentation.

Should you require any other assistance with any aspect of computer systems validation, please let us know and we will endeavour to assist you.

Documentum System Administration

We can help with setting up and running your Documentum system, for example:

· setting up users, groups and permission sets

· running system jobs

· setting up document lifecycles

· writing DQL queries

· writing end-user documentation.

Customised End-User Training

We can also write and deliver end-user presentations and training courses customized to your systems and processes. For example:

· How to author documents in Documentum and use a lifecycle

· The validation process

· Basic DQL

· An introduction to the eCTD

· What does 21CFR11 mean for us?

We look forward to working with you!