Validation Online Compliant Templates.
VIEW OUR SHOP
May 21, 2018
Standard Operating Procedures | Templates | Validation Online
Standard Operating Procedures (SOP's) documents are mandated throughout all cGMP controlled industries. Tasks that are executed in the manufacture of cGMP regulated product must be clearly and concisely documented enabling the operator to replicate the process precisely
Continue reading "Standard Operating Procedures | Templates | Validation Online"
May 21, 2018
Validation Master Plan | FDA | EU | WHO | Pharma | Med-device | Bio-t
VMP is an acronym for "Validation Master Plan", which must verify; by way of documented evidence, that all relevant requirements detailed in 21 CFR Part 210/820 have been integrated into all cGMP related activities undertaken by the company, or on behalf of the company.
Continue reading "Validation Master Plan | FDA | EU | WHO | Pharma | Med-device | Bio-t"
May 21, 2018
GAMP 5 Categories Software | FDA | EU | WHO | QbD | cGMP | FLCV | LC |
GAMP 5 is an acronym for "Good Automatic Manufacturing Practices Issue 5". Compiled by a committee & for GAMP requirements in general; it strives to answer all problems for all people. Learn; from our site, how to extract the data most relevant to your GMP activities.
Continue reading "GAMP 5 Categories Software | FDA | EU | WHO | QbD | cGMP | FLCV | LC |"
May 20, 2018
Computer Qualification | FDA | EU | WHO | Pharma | Med Dev | Bio-Tech
Study and learn by following the integral SOP that forms part of each of our documents. Following these SOP's will take you through the process of changing these templates into your own company bespoke cGMP documents - VMP through VP, URS, VRA, DQ, IQ, OQ, & PQ.
Continue reading "Computer Qualification | FDA | EU | WHO | Pharma | Med Dev | Bio-Tech"
May 20, 2018
Pharmaceutical Validation | FDA | EU | WHO | Pharma | Med-Device | Bio
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.
Continue reading "Pharmaceutical Validation | FDA | EU | WHO | Pharma | Med-Device | Bio"
May 19, 2018
Operation Validation. | FDA | EU | WHO | Pharma | Med-Device | Bio
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.
Continue reading "Operation Validation. | FDA | EU | WHO | Pharma | Med-Device | Bio"
May 19, 2018
Software Validation | FDA | EU | WHO | cGMP | QbD | FLCV | PLC
Learn how software validation can be greatly expedited 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 & Peformance Protocol (4Q). Simpler & Swifter.
Continue reading "Software Validation | FDA | EU | WHO | cGMP | QbD | FLCV | PLC "
May 15, 2018
Software Qualification | FDA | EU | WHO | cGMP | QbD | FLCV | SOP's |
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.
Continue reading "Software Qualification | FDA | EU | WHO | cGMP | QbD | FLCV | SOP's |"
May 14, 2018
IQ OQ PQ | FDA | EU | WHO | GMP | QbD | Pharma | Med Div | Bio Tech |
Learn how the use of our Quality by Design (QbD) interactive IQ OQ PQ combination protocol templates can assure your validation task is correctly risk assessed, scoped appropriately & traceabilities between User Requirements & Test Scripts are portrayed in a matrix display.
Continue reading "IQ OQ PQ | FDA | EU | WHO | GMP | QbD | Pharma | Med Div | Bio Tech | "
May 12, 2018
Validation Quality Plan | FDA | EU | WHO | cGMP | QbD | SOP's |
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.
Continue reading "Validation Quality Plan | FDA | EU | WHO | cGMP | QbD | SOP's | "
May 11, 2018
Validation Online | Drugs | Device | Bio-tec | Machine | Dental | cGMP Templates
Validation Online retails cGMP compliant Validation packages containing VMP, URS, DQ, IQ, OQ & PQ. Or the new VrrP & 4Q two document validation Package.
Continue reading "Validation Online | Drugs | Device | Bio-tec | Machine | Dental | cGMP Templates"
May 10, 2018
zzz-21 211, Validation Documentation | FDA | EU | WHO | Pharma |
zzz-21 211 Commonly known as 21 CFR Part 211. Easy to use fast interactive regulatory compliant document templates. Fully detailed and referenced.
Continue reading "zzz-21 211, Validation Documentation | FDA | EU | WHO | Pharma | "
May 10, 2018
Vendor Audit | FDA | EU | WHO | Pharma | Med-Device | Bio-tech | Test
Learning to become a Vendor Audit expert is entirely dependent on having a powerful targeted audit document. Our vendor audit document has been used by many of the major software suppliers.
Continue reading "Vendor Audit | FDA | EU | WHO | Pharma | Med-Device | Bio-tech | Test"
May 10, 2018
Validation Risk Assessment | FDA | EU | WHO | Pharma | Med-Device | Bi
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.
Continue reading "Validation Risk Assessment | FDA | EU | WHO | Pharma | Med-Device | Bi"
May 10, 2018
Validation Protocol Standards | FDA | EC | WHO | Pharma | Medical | Bio-tec |
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.
Continue reading "Validation Protocol Standards | FDA | EC | WHO | Pharma | Medical | Bio-tec |"
May 10, 2018
Temperature Mapping | FDA | EU | WHO | Pharma | Medical-Dev | Bio-Te |
Learn the techniques and become an expert in cGMP temperature mapping requirements. Temperature Mapping documentation available for instant download for all studies.
Continue reading "Temperature Mapping | FDA | EU | WHO | Pharma | Medical-Dev | Bio-Te |"
May 10, 2018
system Hardware Validation | FDA | EU | WHO | Packages | Protocols |
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.
Continue reading "system Hardware Validation | FDA | EU | WHO | Packages | Protocols | "
May 09, 2018
Planned Preventative Plant Maintenance | FDA | EU | WHO | Pharma | Med-Dev |
It is esentual that your planned preventative plant maintenance (PPPM) program is comprehensive enough to maintain your validated status.
Continue reading "Planned Preventative Plant Maintenance | FDA | EU | WHO | Pharma | Med-Dev |"
May 09, 2018
Retrospective Validation | Rationale | cGMP | Plans | Protocols |
Retrospective Validation is legal and allowed. Far better that you find and remove any cGMP inadequacies rather than having a visiting auditor publish them.
Continue reading "Retrospective Validation | Rationale | cGMP | Plans | Protocols |"
May 09, 2018
Operational Qualification | FDA | EU | WHO | Pharma | Med-Device | Bio
OQ is an acronym for Operational Qualification. Execution of an OQ must produce tangible evidence certifying that all aspects of the equipment under qualification operate within the specifications listed within the User Requirements Specification.
Continue reading "Operational Qualification | FDA | EU | WHO | Pharma | Med-Device | Bio"
May 09, 2018
Medical Device Templates | FDA | EC | WHO | cGMP | QbD | GXP | GDP |
Medical Device Templates. FDA, EC, & WHO Compliant. Innovatice and Intuative documentation.
Continue reading "Medical Device Templates | FDA | EC | WHO | cGMP | QbD | GXP | GDP |"
May 09, 2018
Installation Qualification | FDA | EU | WHO | Pharma | Med-Device | Bio-tech |
Installation Qualification; Our GMP compliant docs start with a VP and progresses through URS, VRA, DQ, IQ, OQ and completes with the PQ. Available as interactive package or as single documents.
Continue reading "Installation Qualification | FDA | EU | WHO | Pharma | Med-Device | Bio-tech |"
May 09, 2018
FDA GMP PART 11 | Applicability | Compliance | Test Scripts.
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.
Continue reading "FDA GMP PART 11 | Applicability | Compliance | Test Scripts."
May 09, 2018
FAT or SAT Initiation and Execution.
FAT or SAT Superb interactive combined IQ/OQ/PQ document ready for instant download.
May 08, 2018
Facility Habitat | FDA | EU | WHO | Pharma | Med-Dev | Bio-tec | Dental | Mech
For all Facility Habitat tasks, learn to use Validation Online's interactive Protocols. These superbly intuitive & innovative documents will deliver the compliance that the regulators demand.
Continue reading "Facility Habitat | FDA | EU | WHO | Pharma | Med-Dev | Bio-tec | Dental | Mech"
May 08, 2018
Facilities Qualification | FDA | EU | WHO | cGMP | Med-Device | Bio-tec | Tests
Facilities Qualification. FDA, WHO & GMP compliant. Fast Cost Effective Protocols, SOP's, Plans & procedural documents.
Continue reading "Facilities Qualification | FDA | EU | WHO | cGMP | Med-Device | Bio-tec | Tests"
May 08, 2018
Design Qualification | FDA | EU | WHO | Pharma | Med-Device | Bio-tech | Test
Execution of a Design Qualification (DQ) protocol must produce tangible verification that all requirements listed in the URS are fully satisfied.
Continue reading "Design Qualification | FDA | EU | WHO | Pharma | Med-Device | Bio-tech | Test"
May 08, 2018
Combined IQ OQ PQ | FDA | EU | WHO | Pharma | Med-Device | 3Q Protocol
This 3Q protocol contains IQ, OQ & PQ protocols that have been integrated & edited to ensure that all wasteful repetition of tests or inspections in the execution stage; have been removed. With a little care; planning, can now integrate many activities with commissioning.
Continue reading "Combined IQ OQ PQ | FDA | EU | WHO | Pharma | Med-Device | 3Q Protocol"
May 08, 2018
Biomed Design Validation (DV).
Biomed Design Validation (DV). GMP compliant, uniquely interactive and highly cost effective Protocols, Plans, SOP's, Risk assessment and many other procedural documents.
May 06, 2018
Corporate Quality Manual | FDA | EU | WHO | Methodologies | Plans | Procedures
Ready for you to review, edit and adopt as your own bespoke Corporate Quality Manual.
Continue reading "Corporate Quality Manual | FDA | EU | WHO | Methodologies | Plans | Procedures"
May 06, 2018
Performance Validation. | FDA | EU | WHO | Drugs | QbD | 4Q Protocol |
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.
Continue reading "Performance Validation. | FDA | EU | WHO | Drugs | QbD | 4Q Protocol |"
May 06, 2018
Computer equipment Validation | FDA | EU | WHO | Pharma | Med Devices
Comprehend how using our risk based, computer equipment, validation protocol templates ensures complete FDA, WHO and EC regulatory compliance.
Continue reading "Computer equipment Validation | FDA | EU | WHO | Pharma | Med Devices "
May 06, 2018
Pharmaceutical Equipment Validation | FDA | EU | WHO | Pharma | Med-Device |
Pharmaceutical Equipment Validation made easy, simply follow intuative protocols and learn by using innovative templates authored by seasoned professionals.
Continue reading "Pharmaceutical Equipment Validation | FDA | EU | WHO | Pharma | Med-Device |"
May 06, 2018
Equipment Qualification | FDA | EU | WHO | Pharma | Med-Dev | Bio-tec
Equipment Qualification & Validation skills are acquired & adopted by staff, when they are using high quality interactive templates. Nothing tutors more quickly or instills more permanently than actual using quality interactive templated protocols.
Continue reading "Equipment Qualification | FDA | EU | WHO | Pharma | Med-Dev | Bio-tec"
May 05, 2018
Autoclave Validation | FDA | EU | WHO | Pharma | Med Device | Biotech |
Autoclave Validation Protocols & Packages. GMP Compliant. simply edit the fully detailed template into your own bespoke protocols.
Continue reading "Autoclave Validation | FDA | EU | WHO | Pharma | Med Device | Biotech |"
May 01, 2018
current Good Manufacturing Practice | FDA | EC | WHO | GMP | QbD | GXP
The acronym cGMP uses the small "c" to accentuate that the statement “current Good Manufacturing Practices” is an ongoing dynamic activity in which preapproved materials and methods are integrated and or manipulated to produce a product of known verifiable specification.
Continue reading "current Good Manufacturing Practice | FDA | EC | WHO | GMP | QbD | GXP"
Apr 30, 2018
Performance Qualification | FDA | EC | WHO | cGMP | QbD | GxP | FLCV |
Performance Qualification (PQ) Scope. Compliant inter-active high quality Process Protocols, SOP's and many other procedural documents.
Continue reading "Performance Qualification | FDA | EC | WHO | cGMP | QbD | GxP | FLCV |"
Apr 28, 2018
Validation Plan | FDA | EU | WHO | cGMP | QbD | GxP | FLCV |
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.
Continue reading "Validation Plan | FDA | EU | WHO | cGMP | QbD | GxP | FLCV | "
Apr 28, 2018
User Requirements Specification | FDA | EU | WHO | cGMP | Pharma | Tes
URS is an acronym for "User Requirements Specification". Which is the most important document in the validation process. The execution of the IQ, OQ and PQ protocols must produce tangible evidence that every requirement listed in the URS has been fully satisfied.
Continue reading "User Requirements Specification | FDA | EU | WHO | cGMP | Pharma | Tes"
Apr 27, 2018
Process Qualification | FDA | EU | WHO | Pharma | Med-dev | Bio-tech |
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.
Continue reading "Process Qualification | FDA | EU | WHO | Pharma | Med-dev | Bio-tech |"
Apr 24, 2018
Validate a Process | FDA | EU | WHO | GMP | Pharma | Med Div | BioTech
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.
Continue reading "Validate a Process | FDA | EU | WHO | GMP | Pharma | Med Div | BioTech"
Apr 23, 2018
Process Validation | FDA | EU | WHO | Pharma | Med-device | Bio-tech |
Successful process validation must certify that an automated systems is capable continuously monitoring; for compliance, all product parameters affected by the said process and that all predicated data is stored in accordance with 21 CFR Part 11.
Continue reading "Process Validation | FDA | EU | WHO | Pharma | Med-device | Bio-tech |"
Mar 17, 2018
System Process Air | FDA | EC | WHO | Protocol | Plan | Package | GMP
Learn all about System Process Air validation. Since air is used in numerous processes throughout any production facility, it must be subjected to the rigors of validation to ensure that it is fit for purpose.
Continue reading "System Process Air | FDA | EC | WHO | Protocol | Plan | Package | GMP"
Mar 05, 2018
Validation Templates | VMP | VP | URS | VRA | DQ | IQ | OQ | PQ | 3Q |
Validation Templates: Every document has a built in SOP for you to follow through the intricacies of converting these fully detailed templates into your own company bespoke documents.
Continue reading "Validation Templates | VMP | VP | URS | VRA | DQ | IQ | OQ | PQ | 3Q |"
Feb 27, 2018
Validation | FDA | EU | WHO | Pharma | Med Device | Bio-tech | Dentis
Validation is the proof by way of tangible evidence that an entity or a system conforms precisely to its specifications.
Continue reading "Validation | FDA | EU | WHO | Pharma | Med Device | Bio-tech | Dentis"
Feb 21, 2018
VALIDATION GAP ANALYSIS | FDA | EU | WHO | Pharma | Med Dev | Bio-tec
Validation Gap Analysis enables you to audit your client's cGMP status. Ensures that the required VMP to PQ via VMP. URS, DQ, IQ, and OQ protocols are cGMP compliant.
Continue reading "VALIDATION GAP ANALYSIS | FDA | EU | WHO | Pharma | Med Dev | Bio-tec"
Jan 29, 2018
Regulatory Requirements | 21 CFR | Parts 820 - 211- 210 & 11
Compliance with Regulatory requirements requires the use of fully detailed templates. Innovative by design and intuative when used ensures your validation will be comprehensive and robust.
Continue reading "Regulatory Requirements | 21 CFR | Parts 820 - 211- 210 & 11 "
Jan 07, 2018
Spreadsheet Validation | FDA | EU | WHO | Pharma | Med-Dev | Bio-Tech |
How to produce Spreadsheet Validation Documents that are intuitive, interactive and fully detailed.
Continue reading "Spreadsheet Validation | FDA | EU | WHO | Pharma | Med-Dev | Bio-Tech |"
For Your Security We are Now TLS 1.2 Compliant
 |