Learn the techniques and become an expert in cGMP compliant temperature mapping requirements. Temperature Mapping documentation available for instant download for fixed and mobile installation qualification studies.
Learn the legal complexities involved in authoring Operational Qualification protocols, by using first class professionally produced templates. Fully referenced & risk rated, with built in traceability, all ready for you to edit them into your own bespoke protocol.
New validation templates were designed specifically to ensure that the basic attributes demanded by the regulators; applicable to each document type, were always there.
GMP Calibration Requirements mandate that calibration periodicities for all critical sensors; used in any regulated process, must be established using a documented company approved methodology. The records generated are to be considered reviewable predicated data.
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.
Although "Good Automatic Manufacturing Practices Issue 5" - GAMP 5 - is not a legal requirement, it does contain some interesting and useful methodology. It is therefore; up to the end user, to extract and apply the methodology that is appropriate to their requirements.
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 why Standard Operating Procedures (SOP's) documents are mandatory throughout all cGMP controlled industries. Tasks that are executed in the manufacture of cGMP regulated product must be concisely documented to guarantee continuous repetitive replication of the process.
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.
For all Facility HVAC tasks, learn to use Validation Online's interactive Protocols. These superbly intuitive & innovative documents will deliver the compliance that the regulators demand.
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.
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.
Learning & understanding the FDA’s requirements for protocols and standard operating procedure documentation; as published in, “Current Good Manufacturing Practice (GMP)” is greatly simplified for the end user, when fully detailed, interactive, templates are made available.
Study and learn how the requirements detailed in 21 CFR Part 11 can render electronic signatures and data as secure as the manually produced and cumbersome; to archive data, it was designed to replace.
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.
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.
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.
It must be understood that validation is a dynamic activity - it is subjected to changes - therefore we must be ready to incorporate these changes. This makes retrospective Validation; not only legal, but a requirement that must be applied when ever justified.
Study & learn about validation of temperature controlled transport by executing the integral SOP (built into each of our templates) will lead you through the process of evolving the template into a company bespoke cGMP protocol. The easier way of mastering cGMP.
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.
Learn all about computer equipment validation by using our fully detailed intuayive and interactive templated document. Follow the inbuilt SOP and edit this template into your own Good Manufacturing Practice (GMP) compliant bespoke company protocol.
Study and learn 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.
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.
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.
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.
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.
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 & FDA predicated traceability from User Requirements to Test Scripts is verifiably maintained.
Learn how to turn this comprehensive in-depth Corporate Quality Manual template, into your own company's bespoke manual; detailing exactly how your company has integrated "continued Good Manufacturing Practices" requirements into all regulated daily activities.
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.
Learn how software validation becomes intuitive when third generation 4Q protocols and plans are used. Start with the Validation, Requirements, Risk & Plan (VrrP) and finish with the combined Design Installation Operation & Performance Protocol (4Q). Simpler & Swifter.
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.
Execution of a Design Qualification (DQ) protocol must produce tangible verification that all requirements listed in the URS are fully satisfied.
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.
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.
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.
It is esentual that your planned preventative plant maintenance (PPPM) program is comprehensive enough to maintain your validated status.
Medical Device Templates. FDA, EC, & WHO Compliant. Innovatice and Intuative documentation.
Using FDA GMP PART 11 validation templates guarantee you produce the thorough and robust audit trail needed to meet all internal or external regulatory reviews or inspections.
Biomed Design Validation (DV). GMP compliant, uniquely interactive and highly cost effective Protocols, Plans, SOP's, Risk assessment and many other procedural documents.
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.
Pharmaceutical Equipment Validation made easy, simply follow intuative protocols and learn by using innovative templates authored by seasoned professionals.
Autoclave Validation Protocols & Packages. GMP Compliant. simply edit the fully detailed template into your own bespoke protocols.