Validation Solution: Digital and agile framework with templates for AI and traditional technologies
[/vc_column_text][vc_btn title=”Learn more” style=”outline-custom” outline_custom_color=”#f3f7fa” outline_custom_hover_background=”#f3f7fa” outline_custom_hover_text=”#161616″ shape=”round” size=”sm” css=”.vc_custom_1742999580084{margin-top: 15px !important;margin-bottom: 100px !important;margin-left: 10px !important;}” el_class=”bt-arrounded” link=”url:https%3A%2F%2Ffivevalidation.com%2Fpaperless-validation%2F|target:_blank” el_id=”learn-more-home”][/vc_column][vc_column width=”2/5″][/vc_column][/vc_row][vc_row][vc_column width=”1/2″][/vc_column][vc_column width=”1/2″][vc_single_image image=”17648″ img_size=”450×352″ alignment=”center” css=”.vc_custom_1738582959934{margin-top: 10px !important;}” el_class=”image-up-header”][/vc_column][/vc_row][vc_row][vc_column width=”1/2″][vc_single_image image=”5019″ img_size=”medium”][/vc_column][vc_column width=”1/2″][vc_column_text el_class=”text-big-home”]We work to minimize the risks of products and services that impact on the health, safety and well-being of families.[/vc_column_text][vc_single_image image=”5053″ img_size=”medium” el_class=”trasparent-img img-big_text”][/vc_column][/vc_row][vc_row css=”.vc_custom_1596082205789{margin-top: 60px !important;}”][vc_column][vc_custom_heading text=”VALIDATION OF AI AND TRADITIONAL TECHNOLOGIES” font_container=”tag:h2|font_size:36|text_align:center|color:%231e646b|line_height:129.19%25″ google_fonts=”font_family:Exo%3A100%2C100italic%2C200%2C200italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic%2C900%2C900italic|font_style:700%20bold%20regular%3A700%3Anormal”][vc_column_text]To avoid risks to the patient or consumer, regulatory agencies such as FDA, EMA, ANVISA and WHO,
require that the pharmaceutical, biotechnology, medical devices and the entire supply chain industries prepare documents
that prove the proper functioning of processes, systems, and equipment.[/vc_column_text][/vc_column][/vc_row][vc_row css=”.vc_custom_1596081910842{margin-top: 100px !important;}”][vc_column][vc_custom_heading text=”WE PROVIDE” font_container=”tag:h2|font_size:36|text_align:center|color:%231e646b|line_height:129.19%25″ google_fonts=”font_family:Exo%3A100%2C100italic%2C200%2C200italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic%2C900%2C900italic|font_style:700%20bold%20regular%3A700%3Anormal” css=”.vc_custom_1597096811502{padding-bottom: 25px !important;}”][vc_row_inner][vc_column_inner width=”1/3″][vc_hoverbox image=”5602″ primary_title=”INDUSTRY” primary_title_font_container=”color:%23f3f7fa” primary_title_google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:700%20bold%20regular%3A700%3Anormal” hover_title=”” use_custom_fonts_primary_title=”true” el_class=”bg-hover-forncemos”]Biotech | Pharmaceutical | Medical Devices | Pharma-chemical | Herbal medicines | Medicinal Gases | Sanitizing | Clinical Research | Cosmetic | Personal hygiene | Perfumes | Distribution and storage | Veterinary | Food | Farming | Clinical lab | Calibration lab | Testing lab | Equipment and systems | suppliers of these companies[/vc_hoverbox][/vc_column_inner][vc_column_inner width=”1/3″][vc_hoverbox image=”5605″ primary_title=”WHAT” primary_title_font_container=”color:%23f3f7fa” primary_title_google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:700%20bold%20regular%3A700%3Anormal” hover_title=”” use_custom_fonts_primary_title=”true” el_class=”bg-hover-forncemos”]SaaS software for all validation types (paperless) | Computer System Validation | Equipment Qualification | Utilities Qualification | IT/OT Infrastructure Qualification (including cybersecurity items) | Implementation of Integrity and Data | Governance projects | Supplier | Qualification | Project management[/vc_hoverbox][/vc_column_inner][vc_column_inner width=”1/3″][vc_hoverbox image=”5599″ primary_title=”HOW” primary_title_font_container=”color:%23f3f7fa” primary_title_google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:700%20bold%20regular%3A700%3Anormal” hover_title=”” use_custom_fonts_primary_title=”true” el_class=”bg-hover-forncemos”]Software paperless GO!FIVE® | Resource allocation | Training and consulting | Turn-key projects (closed scope for the execution of qualifications and validations) | Audit[/vc_hoverbox][/vc_column_inner][/vc_row_inner][vc_empty_space height=”20px”][vc_empty_space height=”20px”][vc_column_text css=”.vc_custom_1712837862580{padding-top: 50px !important;}”]
FIVE Validation carries out validation and qualification projects using GO!FIVE® software 100% paperless.
FIVE client has option (or not) to continue using the paperless model after the project is completed.
The validation documents are delivered in electronic format.
We also provide services in accordance with the guidelines and procedures of each client.
[/vc_column_text][vc_empty_space height=”20px”][/vc_column][/vc_row][vc_row disable_element=”yes” el_class=”row-img-hand”][vc_column width=”1/3″][vc_custom_heading text=”FOCUS ON THE CLIENT” font_container=”tag:h2|text_align:center|color:%23d67c1b” google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:700%20bold%20regular%3A700%3Anormal” el_class=”box-title-b”][vc_custom_heading text=”RECOGNITION” font_container=”tag:h2|text_align:center|color:%23d67c1b” google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:700%20bold%20regular%3A700%3Anormal” el_class=”box-title-b”][/vc_column][vc_column width=”1/3″][vc_custom_heading text=”KNOW HOW” font_container=”tag:h2|text_align:center|color:%23d67c1b” google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:700%20bold%20regular%3A700%3Anormal” el_class=”box-title-b”][vc_custom_heading text=”UPDATED” font_container=”tag:h2|text_align:center|color:%23d67c1b” google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:700%20bold%20regular%3A700%3Anormal” el_class=”box-title-b”][/vc_column][vc_column width=”1/3″][vc_single_image image=”5079″ img_size=”full” el_class=”img-man-like”][/vc_column][/vc_row][vc_row el_class=”row-img-hand”][vc_column][vc_video link=”https://www.youtube.com/watch?v=FX4a4KGWDUY” el_width=”80″ align=”center”][vc_empty_space][/vc_column][/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1596082319269{margin-top: 0px !important;padding-top: 60px !important;padding-bottom: 120px !important;background: #1e646b url(https://site-five.s3.amazonaws.com/wp-content/uploads/2020/07/Mask-Group-3.png?id=5086) !important;}” el_class=”counter-fivemnumeros”][vc_column][vc_custom_heading text=”FIVE IN NUMBERS” font_container=”tag:h2|text_align:center|color:%23d67c1b” google_fonts=”font_family:Exo%3A100%2C100italic%2C200%2C200italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic%2C900%2C900italic|font_style:700%20bold%20regular%3A700%3Anormal”][/vc_column][vc_column width=”1/4″]Quality and/or Innovation Awards*
Market professionals trained by Five
Years of experience
Hours of training provided to the market
Companies served
Hours of training for Five's internal team
Executed projects
Hours of training that the Five team received abroad
*1 CPhI PHARMA AWARDS SHORTLIST 2022, Category Regulatory Procedures & Compliance – Europe[/vc_column_text][/vc_column][/vc_row][vc_row][vc_column][vc_custom_heading text=”FIVE HAS THE COMPLETE” font_container=”tag:h2|text_align:center|color:%231e646b” google_fonts=”font_family:Exo%3A100%2C100italic%2C200%2C200italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic%2C900%2C900italic|font_style:700%20bold%20regular%3A700%3Anormal” css=”.vc_custom_1597195900767{padding-top: 40px !important;padding-bottom: 0px !important;}” el_class=”fivehas-title”][vc_custom_heading text=”SOLUTION IN VALIDATION” font_container=”tag:h2|text_align:center|color:%23d67c1b” google_fonts=”font_family:Exo%3A100%2C100italic%2C200%2C200italic%2C300%2C300italic%2Cregular%2Citalic%2C500%2C500italic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic%2C900%2C900italic|font_style:700%20bold%20regular%3A700%3Anormal”][vc_row_inner css=”.vc_custom_1596080543130{padding-top: 80px !important;}”][vc_column_inner width=”5/12″][vc_single_image image=”5216″ img_size=”full”][/vc_column_inner][vc_column_inner el_class=”collun-five-validation” width=”7/12″ css=”.vc_custom_1596489609411{padding-top: 10px !important;}”][vc_single_image image=”5219″ img_size=”full” onclick=”custom_link” el_class=”img-five-validation-a” link=”https://qad.fivevalidation.com/paperless-validation/”][vc_single_image image=”5863″ img_size=”full” alignment=”right” onclick=”custom_link” el_class=”img-five-validation-b” link=”https://qad.fivevalidation.com/five-training/”][vc_single_image image=”6920″ img_size=”full” alignment=”center”][vc_single_image image=”6323″ img_size=”full” alignment=”center” onclick=”custom_link” el_class=”img-five-validation-c” link=”https://qad.fivevalidation.com/service-solutions/”][vc_custom_heading text=”Efficient compliance through customer focus with complete validation Solution” font_container=”tag:h4|font_size:17px|text_align:center|color:%23606060|line_height:20px” google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:700%20bold%20regular%3A700%3Anormal” el_class=”desc-five-validation”][/vc_column_inner][/vc_row_inner][vc_row_inner css=”.vc_custom_1598870303727{margin-bottom: 60px !important;padding-top: 60px !important;}”][vc_column_inner][vc_empty_space height=”100″][/vc_column_inner][/vc_row_inner][vc_row_inner css=”.vc_custom_1598870303727{margin-bottom: 60px !important;padding-top: 60px !important;}”][vc_column_inner width=”1/2″][vc_single_image image=”5128″ img_size=”medium” el_class=”img-man-down”][/vc_column_inner][vc_column_inner width=”1/2″][vc_custom_heading text=”Traditionally, validation is documented on paper contained in many folders” font_container=”tag:h3|text_align:left|color:%23606060″ google_fonts=”font_family:Open%20Sans%3A300%2C300italic%2Cregular%2Citalic%2C600%2C600italic%2C700%2C700italic%2C800%2C800italic|font_style:700%20bold%20regular%3A700%3Anormal” el_class=”outher-desc-five-validation”][vc_single_image image=”5053″ img_size=”medium” el_class=”trasparent-img img-big_text”][vc_column_text el_class=”w-50 text-list”]
ISSUES
- Burdensome
- Bureaucratic
- Subject to failure
- Slow
- Onerous
RISKS
- Stop production
- Delay product registration
- Cause fines
- Product recall
- Affect the brand image
GO!FIVE Validation®
Software and consulting services.
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Greater Compliance
7x faster
Lower cost
Faster time to market
How to Validate AI in GxP Applications for Life Science Companies
The integration of Artificial Intelligence (AI) into the Life Sciences industry brings innovative potential, from drug discovery to personalized medicine. However, incorporating AI into GxP (Good Practice) environments, which are governed by regulations to ensure product safety and efficacy, introduces additional challenges in AI validation.
GAMP5® 2nd edition and CSA FDA: Why they can be good for business.
Some important points that the second edition of GAMP5® and CSA bring and make us think about ‘how system validations will be from now on.
Why speed in validation activities is a competitive advantage
A term often used in industries is time-to-market, which is the amount of time from the conception of a product to its release.
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