Pharmaceutical QMS Packages
The Quality Management System required for a pharmaceutical organisation depends on what the company does, what it outsources and where the product is in development. OZQA's pharmaceutical QMS Packages are split and designed for every regulatory step. Reduce time, unnecessary resources and build a QMS appropriate to where you organisation is.
QUALITY THROUGHOUT THE LIFECYCLE
Quality for pharma companies.
Quality requirements evolve as a pharmaceutical product moves from early development through clinical trials, marketing authorisation and commercial supply. OZQA helps pharmaceutical and biotechnology organisations understand, establish and develop the Quality systems, processes and documentation needed at each stage of the pharmaceutical lifecycle.
BUILD THE QUALITY FOUNDATION
Pre-clinical quality management.
A practical early stage QMS establishes control of the processes that will continue to matter as the organisation grows. The aim is a fit for purpose quality foundation that can expand when the organisation becomes a clinical trial sponsor.
COMPLETE
PRECLINICAL
___
BUILD A QMS
YOURSELF
Build a QMS yourself with OZQA's 98% pre-written GxP compliant documents. Establish your own complete preclinical QMS with an audit-ready documentation package.
Ideal for
Early stage organisations establishing their first structured QMS with internal QA resources to implement the package.
Package Includes
-
6 pre-written SOP's
-
9 ready to use log forms
-
Step-by-step QMS guide
-
Implementation action log
-
24/7 AI quality support
€5.685
FROM RESEARCH TO CLINICAL TRAILS
Phase I & II quality management.
Early clinical development moves the organisation into a regulated environment. The QMS should support the sponsor in maintaining oversight of activities and provide documented processes.
COMPLETE
PHASE I/II
___
BUILD A QMS
YOURSELF
Build a QMS yourself with OZQA's 98% pre-written GxP compliant documents. Establish your own complete clinical Sponsor QMS with a audit-ready documentation package.
Ideal for
Companies with established core quality processes and internal QA resources to implement the package yourself.
Package Includes
-
13 pre-written SOP's
-
15 ready to use log forms
-
Step-by-step QMS guide
-
Implementation action log
-
24/7 AI quality support
€9.985
FLATE STAGE CLINICAL TRAILS
Phase III quality management.
By Phase III, clinical programmes are typically larger and operationally more complex. The Quality system therefore needs to scale beyond the foundation established during earlier clinical phases.
COMPLETE
PHASE III
___
BUILD A QMS
YOURSELF
Build a QMS yourself with OZQA's 98% pre-written GxP compliant documents. Establish your own complete clinical Sponsor QMS with an audit-ready documentation package.
Ideal for
For organisations entering late stage development without a sufficiently mature quality framework but internal QA resources.
Package Includes
-
38 pre-written SOP's
-
24 ready to use log forms
-
Step-by-step QMS guide
-
Implementation action log
-
24/7 AI quality support
MARKETING AUTORISATION HOLDER
MAH quality management.
The MAH retains responsibility for ensuring that its own activities and relevant outsourced activities comply with applicable EU requirements. The QMS therefore needs appropriate processes for these activities.
COMPLETE
MAH
___
BUILD A QMS
YOURSELF
Build a QMS yourself with OZQA's 98% pre-written GxP compliant documents. Establish your own complete MAH QMS with an audit-ready documentation package.
Ideal for
Organisations becoming an MAH with experienced internal Quality resources available to customise and implement the QMS.
Package Includes
-
38 pre-written SOP's
-
24 ready to use log forms
-
Step-by-step QMS guide
-
Implementation action log
-
24/7 AI quality support
GXP DISTRIBUTION WHOLESALER
GDP quality management.
Companies involved in wholesale distribution of medicinal products have responsibilities relating to Good Distribution Practice. The QMS needs to reflect the actual distribution model, including the use of outsourced warehouses, logistics providers and other partners where applicable.
COMPLETE
GDP
___
BUILD A QMS
YOURSELF
Build a QMS yourself with OZQA's 98% pre-written GxP compliant documents. Establish your own complete GDP QMS with an audit-ready documentation package.
Ideal for
Organisations with outsourced warehouse establishing pharmaceutical distribution activities with internal quality resources available to customise and implement the QMS.
Package Includes
-
Pre-written SOP's
-
Ready to use log forms
-
Step-by-step QMS guide
-
Implementation action log
-
24/7 AI quality support
PHARMACOVIGILANCE SYSTEM
PV quality management.
A Marketing Authorisation Holder must operate a pharmacovigilance system to fulfil its pharmacovigilance obligations. In the EU, this includes an appropriately qualified EU QPPV and a PV System Master File describing the system and relevant outsourced arrangements.
COMPLETE
PV
___
BUILD A PV SYSTEM
YOURSELF
Build a PV system yourself with OZQA's 98% pre-written GxP compliant documents. Establish your own complete EU-PV system with an audit-ready documentation package.
Ideal for
Organisations having in-house EU-PV with experienced internal quality resources available to customise and implement the QMS.
Package Includes
-
Pre-written SOP's
-
Ready to use log forms
-
Step-by-step QMS guide
-
Implementation action log
-
24/7 AI quality support
QUALITY OVERSIGHT ACROSS YOUR PARTNER NETWORK
Managing quality in virtual pharmaceutical companies.
Modern pharmaceutical and biotech companies can operate with surprisingly little infrastructure in house. Development, clinical trials, manufacturing, testing, storage, distribution and pharmacovigilance can all involve external specialists. This makes supplier and partner oversight a central part of the pharmaceutical QMS.
Quality Agreements, qualification, risk assessment, audits, performance monitoring, deviations, CAPAs, changes and documented oversight help establish how responsibilities are controlled across the external network.
The principle is important: Activities can be outsourced. Oversight cannot simply disappear!
GXP THROUGHOUT THE LIFECYCLE
Pharmaceutical quality regulations.
There is no single regulation that defines one identical QMS for every pharmaceutical company. Applicable requirements depend on the company's products, activities, development stage, geography and responsibilities.
 GMP |  GVP |
|---|---|
 GCP |  GDP |
START WHERE YOU ARE
Three ways to build a better QMS.
The OZQA QMS provides ready-to-use quality documents, complete QMS packages designed specifically for regulated companies, and expert quality support. Whether you're starting from scratch, improving an existing system or preparing for your next milestone, we help you focus on what actually matters.
_edited.png)
BUILT TO WORK TOGETHER
Not just individual templates.
Our products are developed as parts of connected Quality processes. Procedures define how the process works and forms capture the required evidence, and related processes connect one document with the wider QMS.
FROM PROCEDURES TO WORKFLOWS
Pharmaceutical QMS digitalisation.
The pharmaceutical QMS may be paper based, document based or implemented within a digital Quality Management System. The technology itself does not determine compliance.
The underlying processes, responsibilities, controls, records and oversight need to be appropriate for their intended use. For computerised systems used in clinical trials, EMA highlights requirements around fitness for purpose, security, audit trails and proportionate risk based validation. Digitalisation can nevertheless make a well designed QMS easier to operate by connecting activities
FREQUENTLLY ASKED QUESTIONS
FAQ
Pharmaceutical Quality Management can look very different depending on your organisation, development stage and regulatory responsibilities. Here, we answer some of the most common questions about pharmaceutical QMS requirements, clinical development, GxP compliance, outsourcing and Quality Management from preclinical development through to commercialisation.