Regulatory Change Control Management

Challenges in Traditional Change Control Processes

Traditional Change Request (CR) processes present many challenges due to inefficiencies, including email chains, document access issues, lack of scalability, and reporting gaps that lead to audit delays. Manual tools and siloed systems make collecting information related to changes difficult, sometimes bringing CRs to a standstill.

During audits, information can take weeks to gather. CR administrators process hundreds of new change requests per year, distributing tasks to users, some of whom do not understand their role in the process.

Macedon Technologies helps companies in the Life Sciences and pharmaceutical industries follow GxP standards for processes through a configurable Appian-powered system for Regulatory Change Control Management (RCCM) that leverages the benefits of Macedon Stage & Gate to simplify regulatory change processes. With Macedon RCCM, companies in highly regulated industries gain scalable, auditable change control that rapidly generates return on investment (ROI).

Key Features & Functionality

Macedon RCCM reduces the time it takes to complete audits from weeks to hours and enables companies to manage 700+ CRs annually. Key Features & Functionality include:

Centralized Dashboards
Automated Task Assignments
SLA-Tied Stages
Advanced Reporting
Auditing
Flexible Process Creation

Business Value & Outcomes

With Macedon RCCM, CR Admins save time and gain control of change requests. The RCCM solution enables organizations across regulated industries to submit, track, and manage their change control requests, processes, data, and assignments through an easy-to-use centralized Appian system built especially to adhere to GxP standards. Macedon RCCM delivers measurable results, including:

Audit Time Reduction
Improved Visibility
Faster Execution
Increased Compliance.

What Our Clients are Saying

“Thanks for your thoughtful solutions,
your anticipation of needs, and just being a great partner to work with.”

Product Owner at a
Regional Bank

“[Macedon] made this project
seem easy. Always prepared,
always on target.”

Product Owner at a Healthcare Organization

“[Macedon] proactively suggests process improvement items that had never occurred to me.”

Sponsor and AVP at an Insurance Organization

Why Choose Macedon for Appian Solutions

Macedon is one of Appian’s oldest and most trusted partners. We are a Premier Appian Partner, meaning our team has the deep expertise needed to provide Regulatory Change Control Management solutions to companies that must follow strict standards. We provide end-to-end development services and ongoing support for Appian low-code process automation solutions, including RCCM. Our track record of success with Appian includes more than 600 engagements for over 100 clients.

Success Stories

Automated Change Control System in Just a Few Weeks

Success Stories

Implementing a Complaint Management Platform in 12 weeks

Blog Post

Solving GxP Change Control Headaches

Managing changes and reviews of standards is challenging with manual tools that make it difficult to collect information about proposed changes in a standardized way, while siloed systems hide this information, making reporting almost impossible.

Poorly defined processes make it hard to corral the right decision-makers (let alone collect their adjudication on decisions) and often do not include record-keeping steps needed for auditability or even for reviewing change effectiveness and value. Regulated industries like Pharmaceutical and Life Science have it especially hard, with stringent auditing requirements and adherence to GxP standards for processes.

Appian-Powered RCCM: Automated Regulatory Change Control Management