Validation Suite - URS, VRA, DQ, IQ, OQ, PQ - all ready for immediate download.
Protocols, such as the
IQ,
OQ,
DQ
and the
PQ
, along with the essential
VMP,
VP,
URS and
VRA, make up a range of regulatory required documentation that has been used on behalf of many clients and has been
repeatedly subjected to Regulatory Authority scrutiny. These,
21 CFR Part 11 compliant documents are continually under
cGMP
review by Validation-Online to ensure that they conform to the regulators current requirements and expectations. These standard format validation protocols are complemented with the addition of detailed specific protocols such as
Computer System Validation (CSV)-
VMP - IQ - OQ -IQ/OQ,
HVAC IQ - OQ - PQ, and
Facilities IQ - QO - PQ.
- REDUCE YOUR VALIDATION COSTS -
Why use up your budget authoring new
VMP’s,
URS,
VP
,
VRA
and GxP documentation for each and every validation project you are
involved in, when there is quality documentation, at budget prices,
available in minutes from Validation Online. Documentation that you can instantly down-load, and convert in minutes, from a generic, to a company bespoke document, using the attached detailed SOP. The SOP is an impressive tool to use, taking you quickly (section by section)through the document completion process. You can show a massive saving in the normal project validation budget, by using these documents. Result is, you look good and so does the project time line.
- USE PROVEN QUALITY DOCUMENTS -
Download, the Validation Online, generic
Installation Qualification Protocol (IQ) or Operational Qualification
Protocol (OQ) directly from Validation Online, auto populate it in
minutes, run through the attached SOP and transform the document into
your own bespoke company document in 20 minutes, complete remaining
requirements in 30 minutes, and issue for approval signatures, all in
less than 60 minutes. Repeat this process for many other regulatory
required documents and protocols.
- FAST PRO-ACTIVE PROTOCOLS FOR YOU -
Download, the right up to date URS from Validation Online (User Requirements Specification), the only URS available that uses a three level approach to ensure that
the traceability demanded for life-cycle validation, is maintained.
Auto populate it, and follow the SOP to complete it, then you have the required regulatory traceability from your
User Requirements Specification (URS) to the
Design Specification (DS) that the regulators now demand. This document ensures that a fully referenced and traceable
DQ can be developed and executed, it also simplifies validation, especially software validation.
- DOCUMENTATION JUST RELEASED. -
As a consultant, the most often asked for service as soon as you arrived in a clients office is, a
GAP ANALYSIS. It is what everyone wants, a detailed review of all aspects of your current systems to determine compliance and adequacy of current procedures. A gap analysis involves comparing regulatory requirements against current procedures and facilities in your facility.
Every One Talks It – Very Few Have It – Get Yours Now. – Click Here.
The
Compendium of Predicate Rules (CPR) has been published to satisfy a requirement that has existed for some time now. It enables you to reference the correct cGMP identity for your requirement, when working with compliance documents. It acts as an aide-mémoire and allows you to be correct and accurate every time. No more boxing around with requirement descriptions - reference your requirements exactly. A really essential tool for all compliance professionals.
- ALWAYS ON-TIME AND IN-BUDGET -
Download from Validation Online the generic
Vendor Audit (VA)
document in minutes, edit it following the attached SOP, incorporate
your project priorities in a further 30 minutes and issue for approval
signature, all in less than 60 minutes. This twenty page document
allows you to weight each section of the questionnaire to exactly
represent your company’s priorities. On completion the analysis allows a very detailed representation of the audited company’s
cGMP
conformance to be confidently made.
- UNCONDITIONALLY GUARANTEED -
These are not simple empty documents; they
are detailed documents that have been successfully used in many
validation projects for pharmaceutical and medical device manufactures
and their subcontractors. Every Validation Online document is
accompanied with a tailor made Standard Operating Procedure (SOP)
document. This SOP details, section by section, the procedure to follow to enable you to grow your generic document, into a detailed bespoke company document.
We have an existing data base of many hundreds of protocols written for a bewildering rage of equipment,
facilities and utilities. From autoclaves cat 3 & 4 – freeze dryers –
mixers – tabletizers – blast freezers – crogenic freezers – fillers – bottle washers – ovens – isolators – laminar flow systems – particle count – quality water – WFI –
clean steam – foil presses – packing machines – refrigerators – low humidity dryers –
nitrogen storage & use – oxygen storage & use- carbon dioxide storage & use – micronizers – laboratory equipment – filter integrity testers – HVAC systems –
category 4 HVAC systems – clean rooms to all iso 14644 standards - and many many more protocols for production and laboratory use.
- PROJECT AHEAD OF TIME IS BRILLIANT -
A single project team member from Validation
Online, has put into place 40 IQ’s in seven days, 30 OQ’s in ten days.
Are you able to match these achievements?
- UNIQUE AND URGENT REQUIREMENT -
If you do not see the document that you require listed in this site, please use our Validation Enquiry form, to let us know, and we will reply within 24 working hours. We are constantly adding to our lists. Our expertise includes writing many standard and specialist documents for the whole spectrum of pharmaceutical and medical device companies covering all aspects of regulatory controlled manufacturing / testing / storing / equipment, facilities and utilities. Validation Online offers a review service for any regulatory required documentation to ascertain if they comply with the applicable regulatory requirements. We have expertise in all the validation skill sets.
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We can provide your company with general compliance services. We have many years of experience in pharmaceutical manufacturing and quality assurance. We can help you comply with cGMPs, GLPs, and GCPs by developing standard operating procedures, developing validation programs and performing audits. At
Validation Online we have built our reputation on providing cost effective compliant solutions to our customers when regulatory changes necessitate. Our professional staff has many years of experience in the FDA regulated industry. We can help you comply with cGMPs, QSR, GLPs, and GCPs by developing :
- Master Validation Plans
- User requirements Specification
- DQ’s, IQ’s, OQ’s and PQ’s.
- Supplementary Protocols and Summary Reports.
- Policies and Procedures
- Quality Systems
- Validation Programs
- Remediation Plans
- Training Programs
- Warning Letter Responses
In addition to the development of compliance solutions, Validation Online, can act as an independent auditing agency to provide you with that extra level of comfort that your systems are meeting the current industry standards and regulations. Whether it’s a one time audit or a recurring periodic audit you can be assured we will listen to your needs and keep the focus where it belongs: on your requirements.
Software, Calibration, Process, Utility, Facility, Computer, Electrical, Electronic, Mechanical, Maintenance, Planning.
