Electronic Records And Signatures Computer Validation Quality Management Systems Purified and WFI Systems Training and Coaching Feedback and Contact
 
   Vulcanbury Ltd.
provide Expert services to reduce your company's business risk for GMP computer systems that need to meet current FDA and MCA regulatory requirements.

   Expert strategies and plans for computer validation and electronic records / signatures (21-CFR-Part11) compliance are provided for new (Prospective) and existing Legacy (Retrospective) computer systems.

The Vulcanbury Mission
To deliver customer compliance through expert solutions.
To deliver efficient validation through tailored tools and practical experience.
To deliver validation clarity through training and coaching services.

Contact Information
   If you would like to know more on how Vulcanbury Ltd services and expertise can help your organisation meet regulatory requirements please submit on the above feedback link or contact on the following:

Telephone: 01634 407893 - 07931 367118
Fax: 01634 407893
Postal address: 17 Fennel Close, The Esplanade, Rochester, Kent, ME1 1LW
Electronic mail
General Information:
ivan_diamond@blueyonder.co.uk

[Homepage] [Electronic Records and Signature] [Computer Validation] [Quality Management Systems]
 [Purified & WFI Systems] [Training and Coaching] [Feedback and Contact]
VULCANBURY LTD, computer validation, COMPUTER VALIDATION, computer systems validation, CSV, csv, validation, VALIDATION, pre-approval inspections, FDA, FDA Inspections, FDA regulations, MCA, MCA Inspections, electronic records and signatures, ELECTRONIC RECORDS AND SIGNATURES, ERES, 21 CFR Part 11, 21cfr part11, GMPs, cGMPs, GXPs, GLPs, documentation, regulatory, failure, compliance, CGMP, Analytical methods, auditing, Active Pharmaceutical Ingredients, Calibration, cGMP training, cGMPs, change control, chromatography, cleaning validation, complaint handling systems, corrective action, design control ,documentation ,equipment validation, facility validation, failure investigation, filtration ,HVAC, Labeling, Laboratory compliance, Packaging, Programmable logic controllers, PLC, quality system regulation, revalidation, standard operating procedures, SOP, SOPs, stability, statistics, sterilization, tablet coating, technology transfer ,viral validation, water systems validation, utilities validation, acceptance criteria, acceptable range, action limits, alert limits, aseptic, biotechnology, certification, Commissioning, control parameters, computer lifecycle, computer validation lifecycle, design qualification, DQ, enterprise resource planning, HPLC, computer validation master plan, csvmp, CSVMP, Installation Qualification, IQ, Operational Qualification, OQ, method validation, nonconformance, operational qualification, performance qualification, PQ, process control parameter, process validation, protocol, quality assurance, quality control, quality management systems, quality policy, quality guidelines, quality system, retrospective validation, prospective validation, sampling, sterility assurance level, thermocouple, upper confidence limit, USP, verification, water-for-injection,WFI, purified water, PURIFIED WATER, risk assessment, prospective validation, potable water, functional testing, edge of failure, concurrent validation, controlled environment, good automated practice, GAMP,

You are the guest
AGORA DESIGN