Autoclave Validation Protocols & Packages. GMP Compliant. simply edit the fully detailed template into your own bespoke protocols.
Software validation mandates that the requirements in the URS be inspected & tested to confirm their presence & compliance. The results of these inspections & tests must produce tangible evidence of compliance. This evidence must be appended to the validation protocols.
GAMP 5 Categories, was authored by a committee; and as such, strives to answer all problems for all people. Great care is required to identify the data applicable to your requirements and edit out all other irrelevant text.
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 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.
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.
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.
Performance Qualification (PQ) Scope. Compliant inter-active high quality Process Protocols, SOP's and many other procedural documents.
Medical Device Templates. FDA, EC, & WHO Compliant. Innovatice and Intuative documentation.
Performance Validation is performed when the equipment is validated against its design specification, as distinct from validating its use in a single process.
Standard Operating Procedures (SOP's) documents are manadated throughout all controlled industries. All tasks that are executed in the manufacture of cGMP regulated product must be clearly and concisely documented enabling the operator to replicate the process exactly.
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.
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.
Successful process validation must certify that a system is capable of continuous critical parameter monitoring that can identify and isolate defects before the whole batch of product is contaminated.
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.
Pharmaceutical Equipment Validation made easy, simply follow intuative protocols and learn by using innovative templates authored by seasoned professionals.
This IQ OQ PQ protocol template is a popular download being easy to follow, or re-vamp into your own company bespoke format. Popular and highly cost effective.s is.
21 211 Commonly known as 21 CFR Part 211. Easy to use fast interactive regulatory compliant document templates. Fully detailed and referenced.
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.
The execution an OQ must verify that all the functionality listed in the user requirements specification has been delivered in a manner compliant with the regulatory requirements pertaining.
Learn the techniques and become an expert in cGMP temperature mapping requirements. Temperature Mapping documentation available for instant download for all studies.
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.
Retrospective Validation is legal and allowed. Far better that you find and remove any cGMP inadequacies rather than having a visiting auditor publish them.
Comprehend how using our risk based, computer equipment, validation protocol templates ensures complete FDA, WHO and EC regulatory compliance.
Equipment Qualification & Validation skills are quickly adopted by staff when high quality interactive templates are used. Nothing tutors quicker or instills more permanently than actual protocols.
How to produce Spreadsheet Validation Documents that are intuitive, interactive and fully detailed.
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.
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.
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.
Documentation Administration that tutors and guides the student requires to be of intuitive and interactive design as all our templates are.
Software Qualification; Our GMP compliant docs start with a VP and progress through URS, VRA, DQ, IQ, OQ and complete with the PQ. Available as interactive package or as single documents..
To understand Pharmaceutical Validation & qualification always use our intuative and interactive protocol templates - VMP through VMP, URS, DQ, IQ, OQ, to PQ.
Amass the intricacies of GMP validation Qualification by using high quality templates. Nothing tutors quicker than using fully detailed, innovative, high quality, interactive templates.
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.
Biotechnology Validation Documentation. Interactive and detailed FDA compliant documentation for the bio-technical industries.
Computer Qualification is easy to understand if you follow the detailed completion SOP’s that form an integral part of all of our protocol templates.
Facilities Qualification. FDA, WHO & GMP compliant. Fast Cost Effective Protocols, SOP's, Plans & procedural documents.
Ready for you to review, edit and adopt as your own bespoke Corporate Quality Manual.
The SOP is an essential tool in the standardization and replication of production and process tasks.
Validation Online retails cGMP compliant Validation packages containing VMP, URS, DQ, IQ, OQ & PQ. Or the new VrrP & 4Q two document validation Package.
It is esentual that your planned preventative plant maintenance (PPPM) program is comprehensive enough to maintain your validated status.
The execution of the IQ, OQ & PQ is required to produce tangible evidense that all the requirements listed in the URS have been fully satisfied.
Execution of a Design Qualification (DQ) protocol must produce tangible verification that all requirements listed in the URS are fully satisfied.
This combined IQ OQ PQ protocol was designed by us for use in simpler validation tasks. In general if an item is stand alone and of simple functionality; then this 3Q document is ideal.
FAT or SAT Superb interactive combined IQ/OQ/PQ document ready for instant download.
A Detailed and Referenced Validation Quality Plan. Simply follow the interactive built in SOP to complete.
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.
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.