Learn how to successfully ensure that your automated process validation verifies that all product parameters that can influence any of the products predicated requirements are continuously monitored. Any out-of-specification - must immediately stop the process.
Learn to use our Quality by Design (QbD) interactive IQ-OQ-PQ combination templated protocol to assure your validation task is correctly risk assessed, scoped appropriately and the FDA predicated traceability from User Requirements to Test Scripts is verifiably maintained.
Although none of GAMP 5 (Good Automatic Manufacturing Practices Issue 5) is legally enforceable, it does debate some practical and useful methodology. It is therefore; up to the enduser, to identify & extract the methodology most appropriate to their requirements.
For all Facility HVAC validation tasks, learn to use Validation Online's interactive Protocols. These superbly intuitive & innovative documents will deliver the compliance that the regulators demand.
Included with this Corporate Quality Manual template, all ready to edit & use, twenty popular protocols templates, six popular SOP templates & eighteen test/inspection scripts. Just follow the integrated completion SOP to produce your own company bespoke Quality Manual.
Learn the easy way; use an industry standard Validation Master Plan (VMP) template & follow the integral completion SOP. This will prompt you into documenting, individual responsibilities, boundaries, methodologies & legislative requirements as specified in cGMP's.
GMP Calibration Requirements mandate that calibration periodicities for all critical sensors; used in regulated process, must be established using documented company approved methodology. The records generated are to be considered reviewable predicated data.
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.
Learning to conduct an impartial GMP vendor audit is entirely dependent on having a properly weighed & targeted audit document, which will allow percentage compliance to be indicated. Auditors will often review it, and suppliers may even contest its legality and objectivity.
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.
FAT or SAT defined: The FAT or Factory Acceptance Testing is written & executed at the vendors test facility & usually witnessed by the client. It involves exhaustive testing of all aspects of the system. The SAT or Site Acceptance Testing is executed at the clients site.
Each Standard Operating Procedure (SOP) details step by step, execution of a regulatory controlled procedure. The regulatory authorities consider both this methodology & execution of the procedures to be “critical records of cGMP compliant production” I.E. predicated data.
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.
The FDA’s “current Good Manufacturing Practices (cGMP)” legislative, as published in 21 CFR Part 210/211/820, becomes easier to understand & comply with when our professionally designed interactive & unique protocol templates are used. Planned progress – with no omissions.
Learn how software validation becomes intuitive when industry standard templates are used. Simply; allow the integral interactive SOP to guide you step by step through the completion process and on to in-budget and on-time line completion.
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.
Need to validate a process in the most expedient and efficient way possible; then use Validation Online's high quality fully referenced protocol templates. Templates that will "pass muster" with your compliance regulators and be economical with your validation budget.
Validation Online design pharmaceutical equipment validation templates that are interactive, intuitive, risk assessed & detailed. The end-user is required to follow the integral SOP which will lead him/her through the completion process & produce an FDA compliant protocol.
Learn all about computer equipment validation by using fully detailed intuitive and interactive templates and simply following the inbuilt completion SOP to edit this template into your own Good Manufacturing Practice (GMP) compliant bespoke company protocol.
Study & learn that the most cost effective way of validating temperature controlled transport systems is by using industry standard interactive validation templates.
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.
Execution of a Design Qualification (DQ) protocol must produce tangible verification that all requirements listed in the URS are fully satisfied.
All our Autoclave Validation Protocols templates contain integral SOP’s. These templates contain step by step instructions for editing the template into a company bespoke protocol. All calculations and methodologies are fully into described and illustrated where needed.
Equipment qualification or validation demands a great deal of attention to detail. Time spent in getting the scope, responsibilities and boundaries properly defined and documented ensures that dreadful blunders are unlikely to appear later-on in the task execution stage.
Performance Validation is when the equipment is validated throughout the full range of its designed capabilities. Usually contract manufacturers validate full equipment specification, whereas actual drug manufacturers will only validate what is used in their own processes.
Training and learning are greatly enhanced when high quality interactive professionally authored Performance Qualification (PQ) templated protocols are in use. Intensity and frequency of all testing, scoping and inspection tasks are all reviewed and sensibly managed.
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
Understanding validation temperature mapping requirements is simplified when industry standard protocol templates with an integral guidance SOP takes you through the completion process step by step. cGMP compliance and on schedule completion are guaranteed.
In risk based validation - your Validation Risk Assessment (VRA) is of quintessential importance if your validation scope is going to match or exceed regulatory expectations.
Tutoring staff in HVAC qualification skills is made easier when interactive fully detailed templated validation protocols are used. The possibility of discovering seriously embarrassing omissions late in the execution stage is costly & can be deleterious to one’s health.
Never validated 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.
Facilities Qualification or validation demands a great deal of attention to detail. Time spent in getting the scope, responsibilities, boundaries and methodologies properly defined will ensure that your validation task progresses in accordance with the planed time-line.
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.
Learn the clever way; use an industry standard, Corporate Validation Manual (CVM) template & follow the in-built fully detailed & interactive SOP, in setting out the scopes, responsibilities, boundaries, methodologies & legislative requirements as per 21 CFR Part 210.
Where compressed plant air is used in production processes, any contact with regulatory controlled product or associated containers necessitates that the air in use is certified to be of an appropriate standard.
21 211. Must define: boundaries, responsibilities, deliverables & requirements. Must specify: life cycle, test scripts, traceability & risk. Must scope: protocols, maintenance & calibration. Must produce: tangible evidence of all validation activities.
Learn the easy way; use industry standard, cGMP compliant Combined IQ-OQ-PQ templates. Fully detailed, intuitive and interactive. Available for: General Equipment: Computer Equipment: Spreadsheets: Quality Steam: Software: Without a doubt the most popular download.
Learning is much easier when professional standard templated Installation Qualification protocols are used. With all details and methodologies in place, the end user is only required to edit the already detailed interactive protocol to suit their exact requirements.
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.
Learn the ideosyncracies of authoring an "User Requirements Specification" (URS) document. The execution of the IQ, OQ and PQ protocols must produce tangible evidence verifying that every requirement listed in the URS has been fully satisfied.
Learn how validation; by way of tangible evidence can establish that an entity or a system conforms precisely to the cGMP rules and regulations.
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.
510k. Must define: boundaries, responsibilities, deliverables & requirements. Must specify: life cycle, test scripts, traceability & risk. Must scope: protocols, maintenance & calibration. Must produce: tangible evidence of all validation activities.
Validation Online retails cGMP compliant Validation packages containing VMP, URS, DQ, IQ, OQ & PQ. Or the new VrrP & 4Q two document validation Package.
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.
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.
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.
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.
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.