ACE typical implementation process:
Project kickoff and requirements gathering: Collaborative meetings are held to define specific organizational needs, compliance requirements, and key workflows for the ACE solution.
Solution configuration and customization: The platform is tailored to match customer processes, forms, user roles, and compliance mandates, ensuring optimal fit for quality operations.
Data migration: Existing quality, compliance, and training records are carefully imported into ACE, often with verification steps to ensure data integrity.
User training and onboarding: End users and admins receive training through workshops, online modules, and documentation to ensure maximum platform adoption and competency.
System validation and testing: The ACE environment goes through rigorous validation and UAT cycles to confirm all workflows, permissions, and integrations meet requirements before going live.
Go-live: The production system is launched, with real users enabled and support channels activated for a smooth transition.
ACE (Adaptive Compliance Engine) can be extensively customized to fit specific business needs, making it highly adaptable for organizations in regulated industries requiring bespoke workflows and compliance processes.
ACE offers configurable workflows, allowing businesses to design approval processes, form fields, and notification triggers that match their internal policies and regulatory mandates.
Users can tailor document templates, data entry screens, and compliance checklists to support their unique quality processes—ensuring company- or product-specific requirements are met.
The software allows the creation of custom user roles and permission sets, so access control can mirror business hierarchies and sensitive data protocols.
Reports and dashboards are fully customizable, enabling organizations to highlight relevant KPIs and compliance metrics specific to their operational goals.
ACE supports integration with ERP, CRM, HR, and manufacturing systems through APIs, ensuring interoperability with custom business environments and datasets.
For life sciences and highly regulated industries, validation and compliance modules can be adapted to fit 21 CFR Part 11, GAMP5, and EU Annex 11 requirements with business-specific documentation.
Companies can implement multi-language support and localization features to accommodate global teams and local regulatory nuances.
ACE (Adaptive Compliance Engine by PSC Software) offers training and support for new users, designed to ensure rapid onboarding and ongoing effective use of the platform.
ACE provides a structured certification program featuring video-based training, guided learning modules, quizzes, hands-on exercises, and a final examination to verify user proficiency. There is also an integrated Learning Management System (ACE LMS), which allows organizations to create custom courses, deliver role-based training, and track compliance. This ensures that users receive tailored training relevant to their specific responsibilities.
New customers benefit from dedicated onboarding assistance and a clear four-stage implementation process that delivers a compliant deployment with minimal business disruption. PSC Software’s team supports data migration, configuration, and initialization, ensuring a fast track to operational readiness. Users can take advantage of a 45-day free trial and discounted configuration services for initial setup.
ACE QMS implements a set of security measures to protect organizational data, meeting industry compliance and regulatory requirements.
ACE supports AES 256-bit encryption for data both at rest and in transit, ensuring high-level protection from unauthorized access. Advanced features like field-level encryption and Bring Your Own Key (BYOK) support are available in the ACE Shield™ module, further enhancing data privacy.
The platform uses permission-based security, enabling administrators to set role-based, process-based, and site-based access controls. Multi-factor authentication, single sign-on (SSO) integration, and Active Directory/OKTA compatibility are included to secure system access.
ACE complies with a range of industry standards, including:
GDPR and SOC 2 for general data security
21 CFR Part 11 for electronic signatures and audit trails, ensuring data integrity and traceability in regulated environments
ISO standards (ISO 9001, ISO 27001, ISO 27017, ISO 27018) for further security assurance, with all cloud hosting delivered via Amazon Web Services (AWS), which holds relevant compliance certifications.
The system tracks all user actions with configurable, tamper-evident audit logs for each record. Electronic signatures and comprehensive reporting dashboards ensure traceability and facilitate regulatory or internal audits.
ACE is cloud-hosted on AWS, leveraging its infrastructure security, including continuous vulnerability management, backup, and disaster recovery protocols.
ACE QMS releases updates on a regular schedule, with new features and security improvements rolled out consistently throughout the year. Updates are managed centrally by PSC Software, and existing users typically receive new features and software enhancements automatically as part of their annual license.
ACE (Adaptive Compliance Engine by PSC Software) maintains strict policies supporting full customer ownership and portability of data stored in the platform.
ACE (PSC Software) contract renewal and cancellation terms offer SaaS-style flexibility and several safeguards for customers, though the specifics may vary slightly by contract type.
ACE contracts often include automatic renewal clauses, but customers can opt out or renegotiate terms in advance of the renewal date by giving written notice.
Price increases for renewals are typically capped—best practice is to ensure price hikes do not exceed 5% per renewal term.
Customers may transition to monthly terms for greater flexibility rather than committing to annual contracts if their needs change.
It is recommended to proactively track renewal dates and usage to negotiate better rates or terms before contract extension and avoid auto-renewals with unfavorable conditions.
PSC will communicate any changes to subscription fees in advance, allowing customers to terminate prior to such changes taking effect.
Cancellation requests must be submitted in writing or through the account portal; the subscription will remain active until the end of the current paid period, with no refunds typically provided for unused time within the ongoing term.
If usage or business circumstances change, customers can request termination or offboarding with proper notice, and PSC will provide guidance for data migration or portability at contract end.
Missing a renewal or notice deadline often triggers automatic renewal of prior terms for the next cycle unless the customer exercises their right to cancel before the renewal window closes.
PSC Software will only terminate accounts for non-payment, breach of terms, or other justifiable cause, with appropriate penalties and late fees indicated in the contract.
Customers are encouraged to review contract utilization, consider consolidation opportunities for tools, and obtain bids from competitors to support negotiations for improved terms.
ACE (Adaptive Compliance Engine by PSC Software) meets a comprehensive set of international, industry, and regulatory compliance standards, making it suitable for use in highly regulated sectors such as life sciences, manufacturing, and healthcare.
FDA 21 CFR Part 11: ACE ensures compliance with U.S. Food and Drug Administration rules for electronic records and electronic signatures, including audit trails, controlled user access, and data integrity features essential for pharmaceutical and biotech companies.
ISO 9001: The platform supports the global standard for quality management systems (QMS), providing document control, corrective actions, and continuous improvement workflows in line with ISO requirements.
ISO 13485: ACE is designed to help companies comply with this medical device industry standard, which mandates traceability, risk management, training management, and document control.
GxP: The platform supports Good Practice (GxP) guidelines relevant to pharmaceuticals, biotechnology, and laboratory environments.
GDPR: ACE offers privacy and data portability controls aligned with the European General Data Protection Regulation (GDPR), supporting structured data export and user control.
