In the life sciences industry, “usability” and “compliance” of digital systems are always two parallel directives. In the past, when building systems such as QMS and LIMS, companies inevitably had to invest in high validation costs, endure long delivery cycles, and constantly face the pressure of “re-validation” during version iterations. However, the times have reached a window where we must do things differently.
Today, we officially release the whitepaper “HAP Support in GxP Computerized System Compliance”, which systematically presents the capability boundaries, validation paths, and system support of Mingdao Cloud HAP under the GxP compliance framework, to clearly answer a long-standing industry question: Can a no-code platform truly enter GxP scenarios? Can it achieve genuine compliance?
Our answer is clear: HAP can not only enter but also reshape the cost structure of traditional CSV.
Highlights
1. It provides a clear positioning of HAP in the GxP environment.
Based on GAMP5 (2022 2nd Edition), HAP is defined as a Category 4 (Configurable Platform). The whitepaper clearly delineates the responsibility model between the Supplier (platform layer) and the Client (business configuration layer), informing enterprises:
- Which validations are handled by the platform (e.g., basic platform IQ/OQ capabilities)
- Which validations need to be completed by the enterprise itself (e.g., PQ/UAT for business processes)
- How to reduce the sunk costs of “repeated validation” without sacrificing compliance
By reading this whitepaper, you will clearly understand: the platform is verifiable, business is controllable, and responsibilities are not confused.
2. It maps the requirements of FDA 21 CFR Part 11 and EU GMP Annex 11 line by line to HAP’s system capabilities.
This is one of the most valuable parts of the whitepaper—it avoids abstract concepts and ambiguity, instead directly providing a technical-level mapping of “regulatory clauses → HAP system support”. It covers five major areas:
- Electronic signatures and identity authentication
- Audit trails and data integrity (ALCOA+)
- Security and access control
- System lifecycle and change management
- Business continuity, backup, and recovery
Each clause can be used for audits, validation, and internal SOP writing. This means enterprises can assess in the shortest time whether their current digital capabilities hold up in the eyes of regulators.
3. It demonstrates HAP’s compliance capabilities in real GxP scenarios.
Including but not limited to:
- Electronic signatures (two-factor authentication, reason for signature, uniqueness, non-transferability)
- Field-level audit trails, tracking changes before and after modifications
- Permission matrix, role system, access security policies
- Configuration export and version tracking (supporting change validation)
- API data exchange logs (supporting interface validation)
For enterprises looking to practically implement GxP business applications such as “CAPA control”, “change control”, “batch release”, “training management”, and “sample flow”, this serves as a ready-to-use technical capability proof.
4. It provides a complete operational guide for enterprises using HAP in a GxP environment.
Specifically including:
- How to perform IQ / OQ / PQ
- How to manage changes in HAP
- How to design backup and recovery drills
- How to manage user permissions
- How to establish training and electronic signature responsibility systems
If you are preparing for inspections, validating new systems, or advancing digital compliance reforms, this section can be directly applied.
Who is this whitepaper for?
- Pharmaceutical and medical device companies advancing the construction of systems such as QMS / LIMS / CAPA / deviation management
- Quality teams facing CSV/SA pressures
- SQA / QA / RA / digital leaders
- IT and engineering teams evaluating whether no-code platforms can enter compliance systems
- Managers needing to make a “platform introduction argument” internally
If you are planning to build the next generation of GxP digital systems, the content of this whitepaper will provide substantial help for your architectural design.
Free Download
We sincerely invite you to read the full version of the whitepaper to gain an in-depth understanding of HAP’s capability system and practical path in GxP computerized system compliance.
Click here or scan the QR code below to fill out the form and access the content.
After reading, if you have further thoughts or questions about GxP digital construction, we welcome discussion and exchange with you.
