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
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.
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.
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.
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.
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.
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 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.
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 Online retails cGMP compliant Validation packages containing VMP, URS, DQ, IQ, OQ & PQ. Or the new VrrP & 4Q two document validation Package.
zzz-21 211 Commonly known as 21 CFR Part 211. Easy to use fast interactive regulatory compliant document templates. Fully detailed and referenced.
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.
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.
Learn the techniques and become an expert in cGMP temperature mapping requirements. Temperature Mapping documentation available for instant download for all studies.
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.
Retrospective Validation is legal and allowed. Far better that you find and remove any cGMP inadequacies rather than having a visiting auditor publish them.
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.
Medical Device Templates. FDA, EC, & WHO Compliant. Innovatice and Intuative documentation.
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.
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.
FAT or SAT Superb interactive combined IQ/OQ/PQ document ready for instant download.
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.
Facilities Qualification. FDA, WHO & GMP compliant. Fast Cost Effective Protocols, SOP's, Plans & procedural documents.
Execution of a Design Qualification (DQ) protocol must produce tangible verification that all requirements listed in the URS are fully satisfied.
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.
Biomed Design Validation (DV). GMP compliant, uniquely interactive and highly cost effective Protocols, Plans, SOP's, Risk assessment and many other procedural documents.
Ready for you to review, edit and adopt as your own bespoke Corporate Quality Manual.
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.
Comprehend how using our risk based, computer equipment, validation protocol templates ensures complete FDA, WHO and EC regulatory compliance.
Pharmaceutical Equipment Validation made easy, simply follow intuative protocols and learn by using innovative templates authored by seasoned professionals.
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.
Autoclave Validation Protocols & Packages. GMP Compliant. simply edit the fully detailed template into your own bespoke protocols.
zzz-Data Logger Specification.
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.
Performance Qualification (PQ) Scope. Compliant inter-active high quality Process Protocols, SOP's and many other procedural documents.
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.
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.
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.
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.
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.
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.
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.
Validation is the proof by way of tangible evidence that an entity or a system conforms precisely to its specifications.
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.
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.
How to produce Spreadsheet Validation Documents that are intuitive, interactive and fully detailed.