Vision

ADPT firmly believes that global CGMP and Data Integrity (DI) should not be complex. We have devised a method to simplify and incorporate these requirements into a virtual solution, facilitating the attainment and maintenance of Global CGMP and Data Integrity compliance for organizations of all sizes. We aim to equip our customers with the tools necessary to reach the pinnacle of regulatory compliance.

SIMPLE-ECONOMICAL-COMPLIANT

Mission

Simplify Global Regulatory Requirements.
Reduce Cost of Compliance.
Revolutionizing system design to develop novel practical systems to meet global CGMP and data integrity requirements.
Share regulatory knowledge.

Implemented Values

Respect
Integrity
Innovation - Creativity
Ethics
Equality
Commitment
Accountability
ECO Friendly

OC 11 Customer's Voice

Same As Paper System

System without changing process and works the same as current paper system.

Global CGMP and Part 11 Compliant

Provide controls required by 21 CFR Part 11 for Electronic Records and Electronic Signature, Data Integrity, and CGMP regulations.

Data Integrity

Prevents unintentional or intentional errors and provides peace of mind to management, their clients, and patients.

Convert Paper Form into Data Integrity System

Software for systems like Change Control, Deviation Management, Corrective and Preventive Actions (CAPA), Market Complaint, Production Specification, Preventive Maintenance System, and calibration.

Videos

CGMP Paper Records

Convert current CGMP paper records into a robust data integrity virtual solution in compliance with CGMP and Data Integrity regulatory requirements.

CGMP System One Validation

Do you feel that current computerized system validation is a never-ending process?

ADPT LLC introduces the breakthrough concept of validated CGMP solutions for all your processes.

CGMP Virtual Solution in Global Languages

Is your organization struggling to meet compliance due to language barriers?

Imagine you have a CGMP 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 CGMP records and documents are available in any local language.

Critical CGMP Data Audit Trail Review

Is critical CGMP data Audit Trail a far-reaching goal?

Here is the simplified and error-proof way of always approaching the CGMP critical Audit Trail review.

AI Training

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 CGMP Regulatory and Data Integrity compliance.

Who We Are

Achieve and Sustain 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.

Knowledge, Experience, and Expertise

We bring in-depth knowledge of interpreting the Global CGMP regulatory requirements and the current U.S. FDA compliance trends.

Compliance Solutions

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 CGMP document into a powerful virtual tool that helps the user prevent making compliance errors.

Imagine

Artificial Intelligence (AI) Capable - Identify and predict potential compliance Issues
Languages - The solution can be developed in any global language
Mandatory Audit Trail Review
Training AI - Auto block users without training
Online Technical Support

Products

OC11 Systems

eQMS - Quality Management System
Manufacturing
Packaging & Labeling

PeP11 LabCal

Proven One Validation Concept - Inspected and Accepted by Regulators
Part 11 Compliant Spreadsheet
Client Server Application

What is Data Integrity?

Data integrity ‒ requirements for complete, consistent, and accurate data.

What is ALCOA?

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)

Important Concepts

Metadata
Audit Trail
Static vs. dynamic records
Backup
Systems

Data integrity is not new

§ 211.68 (requiring that “backup data are exact and complete” and “secure from alteration, inadvertent erasures, or loss” and that “output from the computer… be checked for accuracy”).
§ 212.110(b) (requiring that data be “stored to prevent deterioration or loss”).
§§ 211.100 and 211.160 (requiring that certain activities be “documented at the time of performance” and that laboratory controls be “scientifically sound”).
§ 211.180 (requiring that records be retained as “original records,” or “true copies,” or other “accurate reproductions of the original records”).
§§ 211.188, 211.194, and 212.60(g) (requiring “complete information,” “complete data derived from all tests,” “complete record of all data,” and “complete records of all tests performed”).
§§ 211.22, 211.192, and 211.194(a) (requiring that production and control records be “reviewed” and that laboratory records be “reviewed for accuracy, completeness, and compliance with established standards”).
§§ 211.182, 211.186(a), 211.188(b)(11), and 211.194(a)(8) (requiring that records be “checked,” “verified,” or “reviewed”).

US FDA Data Integrity Guidance

OC11 Platform, A Virtual CGMP Inspector