Software validation must verify by way of tangible evidence; that it can perform, safe to staff & product, whilst matching or exceeding design specification.
The FDA has mandated that the execution of the Operational Qualification (OQ) must produce reviewable evidence which verifies that all Operational-needs, as listed in the User Requirements; are found to equal or surpass their documented acceptance criterias.
Regulatory requirements are easy to comply with when professionally produced protocol templates are used throughout a qualification project.
Learn all about computer validation by using; industry standard, fully detailed, intuitive and interactive protocol & plan templates.
The Medical Device Validation 510k must define boundaries, responsibilities, executables & requirements along with defining life cycle & traceability.
Medical Device Templates. FDA, EC, & WHO Compliant. Innovatice and Intuative documentation.
PLC Qualification, FDA, EC & WHO compliant Protocols, Plans, SOP's, Procedural and Assessment documentation. All available for immediate download.
Execution of a Design Qualification (DQ) protocol must produce tangible verification that all requirements listed in the URS are fully satisfied.
Process Validation – Weighs Methods | Process Validation – Verifies Accuracy | Process Validation - Creates Records | Process Validation – Verifies Efficacy |
The 21 CFR Part 11 software must be used within a frame work of documented mandatory procedures for the stored data to be considered “secure”. The physical safety & security of this software and associated documented procedures along with all hardware must validated.
21 CFR Part 211 Must define: boundaries, responsibilities & executables. Must specify: test scripts, traceability & risk.
Master the Validation Master Plan (VMP) - follow the integral SOP - This will steer you through the process of editing the template into your VMP document.
Equipment Qualification can be defined as; The planned verification of a group of facts; by way of tangible evidence.
Our combined IQ-OQ-PQ is interactive, intuitive and makes a brilliant aid-memoir for the expert or fabulous tutor for the student. Fully detailed & referenced.
For compliance with regulatory requirements a methodology must be used that ensures the intensity of validation; is proportional to the complexity & critically of the item under qualification.
Study and learn the idiosyncrasies of computer qualification by following the integral SOP's that form part of each of our protocol templates. Following these SOP's will take you through the process of changing these templates into your own company bespoke cGMP protocols.
Attention to detail is required in preparing a quality validation plan. Time spent in getting the detail, scope, responsibilities and boundaries properly defined and documented ensures that dreadful blunders are unlikely to appear late in the task execution.
Online Validation guarantees that your protocols will be fit for purpose. Just follow the prefaced interactive SOP to produce cGMP compliant documents.
With a failure indication of over 43%.(EC ) and 23% (US); Everything to do with; Cold Chain Validation, has overnight become the number one topic on everybody's compliance inspection list.
All our Autoclave Validation Protocols templates contain integral SOP’s. These SOP's contain step by step instructions for editing the template into a protocol.
Learn the most cost effect and least intrusive method for complying with the Good Manufacturing Practices legislation requirement for warehouse climatic mapping. Where the accuracy of all data produced must be traceable to national standards.
Validation Templates were first designed for GMP use by this company, when we found that our “On Site” consultants were all authoring the same documents; but producing their own unique versions. Now; 14 years later, the latest edition of each document is instantly available
Validation Protocol standards of wording used in protocols must be accurate & unambiguous to ensure that executing a protocol produces the tangible evidence required to prove regulatory compliance.
Learn that the Validation Plan demands meticulous attention to detail to ensure that a properly balanced schedule of activities is developed. Basic rules and methodologies must be used to determine whether the depth of validation activies is appropriate.
Validation Online Stats; Record this as one of the most commen audit statements - “Your investigations into deviations and out-of-specification (OOS) laboratory results are insufficient, and do not include scientifically-supported conclusions.”
Validation Executables The integrity of individual protocols is kept to ensure compliance. The 4Q combined DQ/IQ/OQ/PQ is now much easier to work and control.
Validation Documentation Matrix is a reviewable indicator. It must portray the cGMP state of all mandated documents in your validation task.
Learn how validation4u; by way of tangible evidence can establish that an entity or a system conforms precisely to the cGMP rules and regulations.
Validation 4u methodology is the most direct route to cGMP compliance available - Use known quality interactive templates and get it right every time.
URS-level 1 = End user needs: URS-Level 2 = Executables + Training + Facility needs. URS-Level 3 = Software functionality in Level 1.
UDI Time Schedules Regulatory Expectations.
The most cost method of validation of temperature safe transit systems is undoutably through using industry standard interactive validation templates. Templates which have been specifically designed to be interactive and intuative to use.
Never validated System Process Air before? Use an industry standard set of validation protocol templates and follow the in-built fully detailed and interactive SOP to guide you; step by step, to on-time and in-budget project completion.
System Hardware Validation docs that are ready for final edit and issue. Docs that not only guarantees compliance, but are also a first class methodology for instilling into validation staff the expectations of their regulators.
Standard Operating Procedure (SOP's) are used to precisely replicate specific methodologies that were developed to produce a controlled product.
How to produce Spreadsheet Validation Documents that are intuitive, interactive and fully detailed.
The SOP-GMP legislative, as published in 21 CFR Part 210/211/820, becomes easier to understand & comply with when professionally authored, interactive & unique protocol templates such as those produced Validation Online; are used, i.e. Planned progress – with no omissions.
Retrospective Validation must be considered "a dynamic activity" - all process changes must be "reviewed for effect" on validation scope and content - This makes retrospective Validation; not only legal, but a requirement that must be applied when ever justified.
SOP for cGMP Review. Uniquely Interactive and Highly Cost Effective Documents for FDA and GMP requirements in the USA & Associated Markets.
Learn how the use of a Software Qualification document package can ensure that your validation task is properly structured, adequately risk assessed and not over scoped. GMP compliant docs start with a VP and progress through URS, VRA, DQ, IQ, OQ and completes with the PQ.
Site Problem Reporting.
Process Qualification used to require three trial batches to be produce and the quality verified. That is still required with certain products. For bulk produce the requirement is for is continuous monitoring of critical parameters & rapid intervention of any OOS's.
Learn the idiosyncrasies of Pharmaceutical Validation by using Validation Online’s uniquely intuitive cGMP compliant templates. An integrated SOP in each document will guide you through the process of converting the template into your own company bespoke document.
Pharmaceutical Equipment Validation (PEV) templates that are interactive, intuitive, risk assessed & fully detailed are the preferred method.
Training & learning are greatly enhanced when high quality interactive professionally authored Performance Qualification (PQ) templated protocols are used.
Tutoring staff in validation skills is made easier when interactive fully detailed templated protocols are used. The possibility of discovering seriously embarrassing omissions when halfway through the execution stage is very costly & can be deleterious to one’s health.
Learn the idiosyncrasies of Machinery validation regulatory requirements as detailled in "Good Manufacturing Practices” legislation, by actual “hands on” editing and execution of industry standard fully detailed, innovative, high quality SOP’s, plans and protocols.
Machinery Qualification is mandatory where a machining process is used in a manner that can affect the quality, efficacy or the integrity of the manufacturing records of a controlled device or drug.