Companies will invest millions of dollars in technologies and consulting services to help them comply with regulations. But although there's an opportunity for companies to leverage those investments to automate and otherwise improve their business processes, few organizations do because they're so focused on meeting rapidly approaching regulatory deadlines. Today's compliance environment not only includes meeting immediate compliance obligations, but also keeping pace with ever-changing regulatory mandates. Today, compliance requirements are affecting increasing number of business processes, with many specialized processes being designed solely to meet industry-specific regulations.

As various compliance initiatives become more intertwined from regulatory and organizational perspectives, multiple and disparate solutions lead to duplicative, and often contradictory, processes and documentation. Such environments do not provide clear visibility into the organizations' risk and compliance profile, bring down efficiency, and escalate the cost of compliance. To deliver business benefit, compliance structures must evolve from geographically and functionally dispersed "silos of compliance," to an enterprise compliance management approach where a standard framework provides the guidance and structure for the entire organization.

Pilgrim provides a common framework and an integrated approach to meet cross-industry mandates and regulations such as ISO/AS/TC 9000, cGxP (GMP, GLP, GCP) standards, as well as the industry-focused regulatory guidelines from FDA, EU, and HACCP/ISO 22000, etc.  In addition, regulatory bodies are increasing their capability and mandates for automation of regulatory reporting and submissions.

Complaint handling and reporting are a critical part of any quality and regulatory compliance program. Adverse Events (AERs) and Medical Device Reporting (eMDRs) can be streamlined for the automated submission and tracking of reports to the appropriate regulatory body. Pilgrim provides automated decision trees, which are also configurable, to assist in medical reportability reviews for the FDA, EU, Canada, Japan and Australia. Pilgrim’s Complaint Management includes all associated regulatory forms including MedWatch, EU MEDDEV, Canada TPP, Australia TGA, and Japan ARR.

FDA-regulated companies frequently experience lengthy approval delays as they bring new products to market or deal with on-going changes. Today, submissions to multiple regulatory bodies are often prepared and submitted through a manual, paper-based process whereby managing the lifecycle, tracking changes, assembling and submitting the right data can be a challenge. Regulatory bodies are increasing mandates to provide regulatory submissions electronically.  Whether you’re managing NDAs, ANDAs, MAAs, INDs, BLAs, PMAs, or 510(k)s, global labeling and other submissions, Pilgrim fully provides all the elements needed for global electronic submissions needs including eCTD or non-eCTD electronic submission (NEES), Structured Product Labeling (SPL), and maintaining Product Core Datasheets, and will help global organizations prepare for the global mandates by regulatory agencies.

Pilgrim Software is the only software vendor that offers a complete suite for regulatory compliance and quality management. Through partnership with our innovative life science customers since the 1990s, Pilgrim Software pioneered electronic signatures, audit trail, and comprehensive off-the-shelf validation scripts to meet US and international industry and regulatory requirements including the FDA’s 21 CFR Part 11.

Pilgrim has also developed a suite of Validation Packs to assist customers to validate the Pilgrim solutions. These ValPacks, which satisfy the guidelines set out by the FDA and GAMP5, are a collection of protocols and test matrices for functions accessible to a user within the Pilgrim solutions.