Specdoc Client List

Specdoc have been contracted by the following companies to provide a range of services.
Click on any symbol for an explanation of each service.


Audit	Documentation	Projects	Quality Assurance	Validation	Electronic Records

Pharmaceutical & Medical Devices

Validation of IT and process computer systems and PLCs across several Glaxo sites, and carying out audits of different systems and suppliers.

	Running a Quality Assurance and specifications seminar.
	Provision of validation consultancy services including IT infrastructure, electronic records & electronic signatures, GxP training courses, supplier audit, and specification and testing of IS systems including SAP R/3 & JD Edwards MRPII and ERP systems. Gap
	Validation consultancy, chairing VWPs, FMEAs, System Risk assessments, project work

Machine documentation, survey and consultancy.

Site survey, followed by validation consultancy. Writing Operating Procedures, gap analysis, 21CFR11 assessments, risk-based assessment, project validation and qualification.

Project lifecycle and validation training course.

Retrospective validation and audit.

Validation support for a number of clients, supplier audits.

Food/Water

Providing engineering management, project procedures, risk management and guidelines and site surveys.

Developing test pack procedures for ISO9002 system and development of ISO9002 standards and procedures.

Writing specifications for CIP system, and coffee roasting plant.

Providing consultancy to review current specifications, writing training documentation and Quality Assurance.

Providing consultancy support for Euro project.

Producing a technology transfer document, carrying out a factory survey and writing a maintenance document.

Writing company operating procedures and booklets, providing a consultancy to review supplier's specifications..

Providing consultancy for development of specifications, project management, including quality assurance, and vendor assessment.

Producing an operation and maintenance manual.

Providing support service for the project manager including Quality Assurance.

A consultancy encompassing evaluation of existing plant and future strategy documentation.

Writing a contractors' handbook, producing specifications for a blending system and oven.

FMEA, functional specification and manual for oven.

Functional specifications for bulk plant.

Functional specifications for biscuit plant.

Consultancy to provide a review of specifications.

Industrial/Commercial/Service

Developing specifications to control major project.

Development and presentation of a training course.

Writing specifications for a major automatic warehousing project.

Providing a consultancy to produce documentation for laboratory instruments.

	Internal audits, quality management system and quality assurance support.
	ISO9000 audits and quality assurance support.
	Electrical, mechanical and civil engineering standards.
	Programming CIP system, Inde Coope.
	Project management software users' manual.

	Quality assurance procedures and working instructions.
	ISO9001/TickIT audit support.
	Project support for plant upgrade.
	Specifications for a water treatment plant.

Design:Ambit