Electronic Records And Signatures Computer Validation Quality Management Systems Purified and WFI Systems Training and Coaching Feedback and Contact
 

PURIFIED AND WFI SYSTEMS

Water is the key ingredient in drug substances and manufacturing processes. Ensuring water quality meets Pharmacopoeia and FDA guidelines is the fundamental requirement of any system.

Vulcanbury Ltd provides expert guidance in designing water systems that meet this requirement across the three key areas of

  Generation
Storage
Distribution



Vulcanbury Ltd has practical experience on the design and control of purified water equipment including Tanks, Pumps, Ultra Violet Lamps, Take off valves, Sampling points, Control systems and Stainless Steel distribution pipework.

Additional support in areas such as critical parameter measurement and control instrumentation ensure client purified and WFI storage and distribution systems are fit for purpose and regulatory inspection.

[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,


AGORA DESIGN