Schedule a Demo - connect@adptllc.com
OC11 Data Integrity (DI) SaaS Solution GxP Algorithms & Single Validation
Inspected by International Regulatory Agencies - No global Part 11, GxP, or Data Integrity Issue was identified.
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Schedule a Demo - connect@adptllc.com
Inspected by International Regulatory Agencies - No global Part 11, GxP, or Data Integrity Issue was identified.
…system without changing process and works the same as current paper system…
…prevents unintentional or intentional errors and provides peace of mind to management, their clients, and patients.
…provide controls required by 21 CFR Part 11 for Electronic Records and Electronic Signature, Data Integrity, and GxP regulations.
…software for systems like Change Control, Deviation Management, Corrective and Preventive Actions (CAPA), Market Complaint, Production Specification, Preventive Maintenance System, and calibration.
Convert current GxP paper records into a robust data integrity virtual solution in compliance with GxP and Data Integrity regulatory requirements.
Do you feel that current computerized system validation is a never-ending process?
ADPT LLC introduces the breakthrough concept of validated GxP solutions for all your processes.
Is your organization struggling to meet compliance due to language barriers?
Imagine you have a GxP virtual solution that can be adapted to your preferred global language with less cost, time, and effort.
At ADPT LLC, we believe compliance can be easily achieved when GxP records and documents are available in any local language.
Is critical GxP data Audit Trail a far-reaching goal?
Here is the simplified and error-proof way of always approaching the GxP critical Audit Trail review.
Is Training management cumbersome?
ADPT LLC introduces Artificial Intelligence in Pharmaceutical Quality and Data Integrity. We built the next-generation virtual solution for achieving and sustaining Global GxP Regulatory and Data Integrity compliance.
Established in 2006, we bring one proven validation concept with our Pep 11 compliance tool to reduce costs and resources. Our core competency is to help our clients achieve and sustain compliance, meeting all global regulatory and data integrity requirements.
We bring in-depth knowledge of interpreting the Global GxP regulatory requirements and the current U.S. FDA compliance trends.
One validation Excel tool, PeP11 LabCal, was inspected by the FDA with no observations from the past ten years. We expanded our innovation to the word processor tool OC11 virtual solution (One Stop Global Regulatory Compliance tool) to achieve and sustain compliance. Word processors are widely used in the pharmaceutical industry to create forms and documents. Since OC11 is based on the word processor tool, which minimizes the learning curve, the user can transform any MS Word GxP document into a powerful virtual tool that helps the user prevent making compliance errors.
Data integrity ‒ requirements for complete, consistent, and accurate data.
Attributable - 21 CFR Parts, 211.101(d), 211.122, 211.186, 211.188(b)(11), and 212.50(c)(10)
Legible - 21 CFR Parts 211.180(e) and 212.110(b)
Contemporaneous - 21 CFR Parts 211.100(b) and 211.160(a)
Original or true copy - 21 CFR Parts 211.180 and 211.194(a)
Accurate - 21 CFR Parts 211.22(a), 211.68, 211.188, and 212.60(g)
Data Integrity Requirements