Accelerate the Development, Registration, and Commercialization of Pharma and Biotech Products
Achieve Validation Compliance with GO!FIVE® (6x faster), from idea to patient
Pharmaceuticals (including API*) and biotech companies operate under strict regulations and must demonstrate that their development processes and final products are consistent.
Validation and qualification play a crucial role in ensuring this compliance.
But, do you know that compliance efforts can impact more than 30% of profits**?
30% of profits**
* API = Active Pharmaceutical Ingredient | **Access the reference source by clicking here
IT system implementation projects often have go-live dates firmly committed to by company management. However, do you know which project tasks will be delayed and who will be pressured to complete validation tests in less time?
That's right, it's you, the validation professional! Those in this field frequently find their schedules compressed. Are you tired of this situation?
What if you had a tool that could make your work 6 times faster?
As a validation professional, you often write requirements, assess risks, and develop tests based on input from experts. However, when it comes to running these tests, it's common to encounter scenarios that are no longer appropriate, requiring you to open deviations or incidents.
Imagine having a tool that uses agile methods to quickly version only the impacted test item and promptly resubmit it for approval. Wouldn't that be amazing? Now, you can rely on the digital validation solution, GO!FIVE®.
The main challenges for small and medium companies:
- Lack of a skilled validation workforce.
- Takes time to train professionals.
- Validation can delay product registration and production.
- Organization of documents.
- Adapt layout and configure documents.
Note.: improperly indexing test evidence can result in non-conformities.
How can we increase productivity, reduce costs, and optimize time if hiring another person isn't the solution?
The answer lies in GO!FIVE®, a digital validation software with integrated solutions designed for biopharma teams. It simplifies submission processes and audit preparations while accelerating the time-to-market.
- 6x more productive.
- Different reviewers at the same deliverable.
- Access several contents and libraries.
- Automatic document formatting.
- Off-the-shelf system.
- Quick and free deployment.
With GO!FIVE®, it’s possible to comply with the various pharmaceutical and biotech standards, including:
- Regulatory Agencies: FDA 21 CFR Part 11, FDA 21 CFR Part 210, FDA 21 CFR Part 211, ANNEX 11 EMA, ANNEX 15 EMA
- Quality System: ICH Q8, ICH Q9, ICH Q10
- Cyber Security: ISO 27001:2022, GDPR, HIPPA, and NIST Cybersecurity Framework
- Data Integrity: EMA Questions and Answers – Ago/2016; FDA Guideline - Data Integrity and Compliance with Drug CGMP – Questions and Answers – Guidance for Industry – Dez/2018; MHRA Medicine & Healthcare products Regulatory Agency MHRA – GXP Data Integrity Guidance and Definitions – Mar/2018; PIC/S PI 041-1 Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments – Jul/2021; WHO Guideline on data integrity, WHO TRS 1033, starting on page 135, 2021
With GO!FIVE, you can perform various types of validation:
- Computer System Validation
- Equipment Qualification
- Utilities Qualification
- IT and OT Infrastructure Qualification
- Process Validation*
- Cleaning Validation*
- Method Validation*
- Transport Qualification*.
(*) some improvements are in progress.
Do you work in a small or medium-sized company without a dedicated validation team for software operations? Are you looking for a cost-effective and reliable service provider?
Or, do you work for a large pharmaceutical or biotechnology company with occasional high demands that require team reinforcement? Are you in need of a credible and affordable service provider?
FIVE Validation offers services tailored to these needs. Click here to see how we can help.
Click here to learn more about GO!FIVE®
Accelerate time-to-market, reducing validation and qualification time by 6x, streamlining compliance and at a lower cost!
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