You're getting audited by pharmaceutical and biotech customers. They want to see controlled documents, real audit trails, and training records. We help you show them exactly that, within the Microsoft 365 you already own.
GxP Document Control
for Regulated Suppliers
GxP Document Control
for Regulated Suppliers
Key Benefits
Document lifecycle management, electronic signatures, and
immutable audit trails. Uses your existing Microsoft 365.
Document lifecycle management, electronic signatures, and immutable audit trails. Uses your existing Microsoft 365.
Built for customer audits (21 CFR Part 11 + EU GMP Annex 11)
Uses your existing
Microsoft 365
Validation templates
included
Do You Know Your Audit Exposure Risk?
A short assessment to benchmark your current practices against audit-ready expectations.
A short assessment to benchmark your current practices
against audit-ready expectations.
Why Suppliers Need This
You supply pharmaceutical, biotech, or medical device companies. They audit you annually. And they keep finding the same problems:
Problems You Can’t Ignore
Your documents don't have proper version control. People are using old SOPs. Training records are in Excel. You can't prove who approved what. Your audit trail is buried somewhere in SharePoint admin logs that nobody can actually read.
Problems You Can’t Ignore
Your documents don't have proper version control. People are using old SOPs. Training records are in Excel. You can't prove who approved what. Your audit trail is buried somewhere in SharePoint admin logs that nobody can actually read.
Problems You Can’t Ignore
Your documents don't have proper version control. People are using old SOPs. Training records are in Excel. You can't prove who approved what. Your audit trail is buried somewhere in SharePoint admin logs that nobody can actually read.
Audit Consequences
These aren't small issues. They turn into formal observations. CAPA requirements. Follow-up audits. And if you can't fix them, you lose your approved supplier status.
Audit Consequences
These aren't small issues. They turn into formal observations. CAPA requirements. Follow-up audits. And if you can't fix them, you lose your approved supplier status.
Audit Consequences
These aren't small issues. They turn into formal observations. CAPA requirements. Follow-up audits. And if you can't fix them, you lose your approved supplier status.
No Good Options
The real problem? You're stuck between two bad options. Keep using Excel and email (doesn't work). Or buy an enterprise QMS platform designed for Pfizer (costs more than your entire quality budget and takes 18 months to implement).
No Good Options
The real problem? You're stuck between two bad options. Keep using Excel and email (doesn't work). Or buy an enterprise QMS platform designed for Pfizer (costs more than your entire quality budget and takes 18 months to implement).
No Good Options
The real problem? You're stuck between two bad options. Keep using Excel and email (doesn't work). Or buy an enterprise QMS platform designed for Pfizer (costs more than your entire quality budget and takes 18 months to implement).
ValidaPoint fixes the fundamentals. Document control, signatures, audit
trails, training. Without the cost and complexity of systems you don't need.
Who We Serve
Who We Serve
Who We Serve
Who We Serve
We work with two types of organizations:
Suppliers in
Regulated Industries
You support pharmaceutical, biotech, medical device, or food manufacturers. They audit you regularly. You need controls that survive those audits without investing in enterprise QMS platforms.
Suppliers in
Regulated Industries
You support pharmaceutical, biotech, medical device, or food manufacturers. They audit you regularly. You need controls that survive those audits without investing in enterprise QMS platforms.
Suppliers in
Regulated Industries
You support pharmaceutical, biotech, medical device, or food manufacturers. They audit you regularly. You need controls that survive those audits without investing in enterprise QMS platforms.
Life Sciences
Manufacturers
Life Sciences
Manufacturers
Life Sciences
Manufacturers
Capabilities
What Changes
ValidaPoint eliminates the compliance gaps that cause recurring audit findings.
Manual Email Approvals
Documents routed via email. Lost in inboxes.
Zero proof of who approved what or when.
BEFORE
Manual Email Approvals
Role-based routing with deadlines. Cryptographic signatures. Tamper-evident audit trails. The evidence auditors ask for exists.
AFTER
"The efficiency and professionalism of Logis have exceeded our expectations. Their seamless service has made shipping stress-free and reliable!"
Emma T., Logistics Manager
"Thanks to Logis, we’ve improved delivery times and minimized disruptions. Their dedication to excellence has made them a trusted partner!"
Lucas M., Operations Supervisor
"Logis delivers outstanding service with unmatched reliability. Their expertise and innovative solutions have greatly optimized our operations!"
Olivia S., Supply Chain Director
Capabilities
What Changes
ValidaPoint eliminates the compliance gaps that cause recurring audit findings.
Manual Email Approvals
Documents routed via email. Lost in inboxes.
Zero proof of who approved what or when.
BEFORE
Manual Email Approvals
Role-based routing with deadlines. Cryptographic signatures. Tamper-evident audit trails. The evidence auditors ask for exists.
AFTER
"The efficiency and professionalism of Logis have exceeded our expectations. Their seamless service has made shipping stress-free and reliable!"
Emma T., Logistics Manager
"Thanks to Logis, we’ve improved delivery times and minimized disruptions. Their dedication to excellence has made them a trusted partner!"
Lucas M., Operations Supervisor
"Logis delivers outstanding service with unmatched reliability. Their expertise and innovative solutions have greatly optimized our operations!"
Olivia S., Supply Chain Director
Capabilities
What Changes
ValidaPoint eliminates the compliance gaps that cause recurring audit findings.
Manual Email Approvals
Documents routed via email. Lost in inboxes. Zero proof of who approved what or when.
BEFORE
Manual Email Approvals
Role-based routing with deadlines. Cryptographic signatures. Tamper-evident audit trails. The evidence auditors ask for exists.
AFTER
"The efficiency and professionalism of Logis have exceeded our expectations. Their seamless service has made shipping stress-free and reliable!"
Emma T., Logistics Manager
"Thanks to Logis, we’ve improved delivery times and minimized disruptions. Their dedication to excellence has made them a trusted partner!"
Lucas M., Operations Supervisor
"Logis delivers outstanding service with unmatched reliability. Their expertise and innovative solutions have greatly optimized our operations!"
Olivia S., Supply Chain Director
GxP Compliance
GxP Compliance
GxP Compliance
Built for Customer Audits & GxP Requirements
ValidaPoint supports customer audit expectations and GxP requirements (21 CFR Part 11 + EU GMP Annex 11) for document management, electronic signatures, and audit trails.
This isn't "GxP-light." We enforce lifecycle controls, provide immutable audit trails, use cryptographic signatures, and include validation templates.
But we're not a full QMS replacement. We focus on document control fundamentals. Not batch manufacturing, LIMS, complaint management, or supply chain qualification. That focused scope means faster deployment and lower cost while meeting customer audit requirements.
Technical Features
Technical Features
Technical Features
Technical Features
Technical Features
Technical Features
Positioning
Positioning
Positioning
The Supplier Gap
Suppliers in regulated industries face a specific problem. High regulatory pressure through customer audits. But limited access to risk-proportionate quality systems.
Your options have been:
No formal system
Excel trackers, email approvals, SharePoint folders. Results in recurring audit findings.
No formal system
Excel trackers, email approvals, SharePoint folders. Results in recurring audit findings.
No formal system
Excel trackers, email approvals, SharePoint folders. Results in recurring audit findings.
Oversized enterprise QMS
TrackWise, Veeva, MasterControl. Prohibitive cost. Complex validation. 6-18 month implementations. Built for pharmaceutical manufacturers, not suppliers.
Oversized enterprise QMS
TrackWise, Veeva, MasterControl. Prohibitive cost. Complex validation. 6-18 month implementations. Built for pharmaceutical manufacturers, not suppliers.
Oversized enterprise QMS
TrackWise, Veeva, MasterControl. Prohibitive cost. Complex validation. 6-18 month implementations. Built for pharmaceutical manufacturers, not suppliers.
Basic SharePoint
Lacks GxP controls. No audit trail capability. No training enforcement. Not defensible in audits.
Basic SharePoint
Lacks GxP controls. No audit trail capability. No training enforcement. Not defensible in audits.
Basic SharePoint
Lacks GxP controls. No audit trail capability. No training enforcement. Not defensible in audits.
ValidaPoint fills this gap. Audit-defensible document control built for supplier scale and risk profiles
Feature Comparison
Feature
Feature
Target Market
Target Market
Implementation Time
Implementation
Time
Customer Audit Ready
Customer Audit
Ready
21 CFR Part 11 Support
21 CFR Part 11
Support
EU GMP Annex 11 Support
EU GMP Annex
11 Support
Uses Existing Infrastructure
Uses Existing
Infrastructure
User Training Required
User Training
Required
Tamper-Evident Audit Trail
Tamper-Evident
Audit Trail
Electronic Signatures
Electronic
Signatures
Validation Templates
Validation
Templates
IT Resources Needed
IT Resources
Needed
Risk-Proportionate for Suppliers
Risk-
Proportionate
for Suppliers
ValidaPoint
ValidaPoint
Suppliers & small-mid pharma
Suppliers & small-mid
pharma
Suppliers &
small-mid
pharma
4-8 weeks
4-8 weeks
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Minimal
Minimal
Yes
Yes
Included
Included
Pre-built
Pre-built
Low
Low
Yes
Yes
Enterprise QMS
Enterprise
QMS
Large pharma manufacturers
Large
pharma
manufacturers
6-18 months
6-18 months
Yes
Yes
Yes
Yes
Yes
Yes
No
No
Extensive
Extensive
Yes
Yes
Often extra
Often extra
Custom
Custom
High
High
No
No
Manual SharePoint
Manual
SharePoint
Any organization
Any
organization
On going
On going
No
No
No
No
No
No
Partial
Partial
N/A
N/A
No
No
No
No
Manual
Manual
Medium
Medium
No
No
Supplier Performance
Supplier Performance
Supplier Performance
Beyond Compliance: Your Commercial Reputation
Suppliers face more than just audits. Your customers evaluate your
performance annually. These scores directly impact business continuity
Suppliers face more than just audits. Your customers evaluate your performance annually. These scores directly impact business continuity
Common evaluation criteria:
Common evaluation criteria:
⚠️ Quality complaints and OOS/OOT incidents
📑 Documentation errors (incorrect CoA,
incomplete records, wrong versions)
🚛 Delivery delays and stock shortages
🔁 Recurrent deviations and poor CAPA responses
🔁 Recurrent deviations and poor CAPA
responses
How Document Failures
Impact Your Business
Weak document control contributes to (and sometimes
causes) poor supplier performance scores.
Weak document control contributes to (and sometimes causes) poor supplier performance scores.
(01)
Wrong document versions lead to errors.
(01)
Wrong document versions lead to errors.
(01)
Wrong document versions lead to errors.
(02)
Errors lead to complaints
(02)
Errors lead to complaints
(02)
Errors lead to complaints
(03)
Complaints impact your score
(03)
Complaints impact your score
(03)
Complaints impact your score
(04)
Low scores risk your business
(04)
Low scores risk your business
(04)
Low scores risk your business
ValidaPoint eliminates these documentary failures. Reduces operational errors.
Improves your positioning with strategic customers.
ValidaPoint eliminates these documentary failures. Reduces operational errors. Improves your positioning with strategic customers.
ValidaPoint eliminates these documentary failures. Reduces operational errors. Improves your positioning with strategic customers.
Not just compliance.
Commercial performance.
Team & Experience
Team & Experience
Team & Experience
Who Built This
ValidaPoint comes from people who've worked both sides: pharmaceutical QA and supplier audits.
Pharmaceutical Quality Systems:
👷🏻 20+ years operational QA (Bayer, MSD, Abbott, mAbxience)
🏢 FDA, EMA, and ANMAT inspections
🔎 Customer and regulatory audit experience
🔗 Supplier management and qualification programs
✅ GAMP 5 validation methodology
Supplier Audit Experience:
🔍 Extensive supplier audit background across categories
📦 Raw materials, packaging, logistics, technical services, laboratories
🫱🏻🫲🏼 Understanding of real supplier constraints
⚖️ Focus on risk-proportionate solutions, not oversized platforms
Microsoft 365 & SharePoint:
👷🏻 10+ years enterprise SharePoint architecture
🔐 Microsoft 365 security and governance
🏢 Clients include Johnson & Johnson, Corbion, Alliander
🧩 Azure Functions, SQL Ledger, cryptographic systems
"We understand pharmaceutical regulatory expectations and supplier operational reality."
Resources
Resources
Educational materials to help you understand GxP document control requirements and common supplier audit observations.
Document
Resources
Resources
Educational materials to help you understand GxP document control requirements and common supplier audit observations.
Document
Resources
Resources
Educational materials to help you understand GxP document control requirements and common supplier audit observations.
Document
FAQ
FAQ
FAQ
Frequently Asked Questions
Can this handle multiple customer requirements?
Can this handle multiple customer requirements?
Can this handle multiple customer requirements?
Do you support multiple languages?
Do you support multiple languages?
Do you support multiple languages?
How long does implementation take?
How long does implementation take?
How long does implementation take?
What if Microsoft 365 goes down?
What if Microsoft 365 goes down?
What if Microsoft 365 goes down?
What validation documentation is included?
What validation documentation is included?
What validation documentation is included?
Why cryptographic signatures instead of DocuSign?
Why cryptographic signatures instead of DocuSign?
Why cryptographic signatures instead of DocuSign?
Is SharePoint really Part 11 compliant?
Is SharePoint really Part 11 compliant?
Is SharePoint really Part 11 compliant?
How does this compare to enterprise QMS for suppliers?
How does this compare to enterprise QMS for suppliers?
How does this compare to enterprise QMS for suppliers?
Is this for suppliers or manufacturers?
Is this for suppliers or manufacturers?
Is this for suppliers or manufacturers?
What customer audit standards does this support?
What customer audit standards does this support?
What customer audit standards does this support?
Inquiries
ValidaPoint works with suppliers in regulated industries, pharmaceutical, biotech, and
medical device organizations implementing GxP document control within Microsoft 365.
Contact Options:
Send Us an Email
To discuss ValidaPoint for your organization
Email: contact@validapoint.com
Please Inclue:
Brief description of your organization (supplier category or manufacturer type)
Current documentation approach and compliance requirements
Recent audit observations or regulatory pressure (if applicable)
Timeline considerations
*We typically respond within 2 business days.
Visit Us on LinkedIn
Inquiries
ValidaPoint works with suppliers in regulated industries, pharmaceutical, biotech, and
medical device organizations implementing GxP document control within Microsoft 365.
Contact Options:
Send Us an Email
To discuss ValidaPoint for your organization
Email: contact@validapoint.com
Please Inclue:
Brief description of your organization (supplier category or manufacturer type)
Current documentation approach and compliance requirements
Recent audit observations or regulatory pressure (if applicable)
Timeline considerations
*We typically respond within 2 business days.
Visit Us on LinkedIn
Inquiries
ValidaPoint works with suppliers in regulated industries, pharmaceutical, biotech, and
medical device organizations implementing GxP document control within Microsoft 365.
Contact Options:
Send Us an Email
To discuss ValidaPoint for your organization
Email: contact@validapoint.com
Please Inclue:
Brief description of your organization (supplier category or manufacturer type)
Current documentation approach and compliance requirements
Recent audit observations or regulatory pressure (if applicable)
Timeline considerations
*We typically respond within 2 business days.