Overview

In a world of cut-throat competition, the only attribute that can define the success for your business/idea is the superior quality. When it is referred to Pharma/Bio-technology/Cosmetics/Medical Device industries, the quality can be defined by the GxPs or Standard Operating Procedures (SOPs) manufacturers implement and follow throughout the life cycle. How to ensure the quality is maintained? That demands a robust Quality Management System (QMS). However, designing and implementing the QMS, may sometimes, require organizations to invest lot of time and money to research about global legislations and to perennially update the systems. In such scenarios organizations look for a quality QMS remediation partner.

With a comprehensive knowledge on writing new SOPs or amending/changing existing ones, Freyr offers the suite of QMS Remediation support services. Having an expert team with complete understanding of global compliance scenario, Freyr offers end-to-end QMS remediation services that span across: 

With an in-depth knowledge on global Health Authority (HA) Regulatory requirements, Freyr offers specialized GxP audit services to assist Pharmaceutical, Biotechnology, and Medical devices organizations to design, develop and implement good procedural practices. Freyr ensures compliance with geo-specific GxPs and applicable regulations that are unique and best suitable to your company's Regulatory requirements.

 

Freyr Expertise

SOP Gap Analysis

While expanding businesses to newer markets, life sciences organizations required to develop new SOPs based on the regional Regulatory requirements or should update/upgrade the existing processes to align them new demands. But prior to SOP development, it is indeed a right approach to identify the gap between processes and remediate them accordingly.

To support organization’s need to develop new SOPs or enhance the existing ones, Freyr performs SOP gap analysis and remediate effectively to fill in these gaps. Freyr proposes how to change SOPs and how to articulate new SOPs based on which training is provided. Freyr implements the ‘train the trainers’ program to ensure the future operations unaffected.

  • SOP Gap Analysis
  • Remediation
  • Training

SOP Standardization

As the business grows, the standards to be followed or adhered will also increase. There will be times when a customer falls under so many ISO standards and is required to follow each standard. In such scenarios, maintaining and following different stream of SOPs for each standard will double up the procedural complexities for companies. The need of the hour is to unify or standardize the SOPs.

Following the risk-based approach and common control framework methodologies, Freyr supports organizations with integrated SOPs catering to all Regulatory requirements which they fall under. Freyr’s expert group of QMS remediation can establish process architecture by integration of multiple regulations for unified management systems (ISO 9001, ISO 27001, Medical Devices - 13485, GLP - 17025, Medical Laboratories - 15189, CAP with United States Food and Drug Administration (USFDA), EMEA, MHLW, World Health Organization (WHO), GxP, ICH).

  • Process designing
  • Establishing process architecture
  • SOP standardization
  • Risk-based approach
  • Common control framework
  • Integration of multiple regulations for unified management systems

SOP Rationalisation

At times, organizations write the SOPs to just let go the audit. But alas, those SOPs are hardly of any use to implement. Either they are not followed by employees or they could make processes complex, if integrated. To avoid such situations, it is needed to rationalize the SOPs that brings some value to organizations time and resources.

Supporting organizations to come off writing SOPs to just pass audits, Freyr designs SOPs and rationalize them to make business sense in addition to complying with applicable regulations. Thus, to bring in real value to company.

  • Preparing SOPs that makes business sense
  • SOP gap analysis
  • Remediation
  • Training

SOP Reconciliation and Optimization

Though there is no set guideline, as a general practice, for every two years SOPs have to be rewritten or they need to be updated. With periodical updates or enhancements, there is a chance for quality systems changed and SOPs amended for many a times and there is even a chance for self-contradictory documents. With different formats and versions accumulating, there is always a chance for overlapping and duplication. During such times, organizations are required to showcase they are continuously monitoring the SOPs.

With a clear-cut knowledge on SOPs and quality systems, Freyr assists organizations to reconcile and optimize the SOPs, periodically. Freyr’s expert compliance team develops new SOPs and carry out incremental updates. In addition, for every two years, Freyr supports organizations to file “revised with no change,” if there are no updates to be recorded.

  • Clean up the junk files accumulated over the years
  • Reconciles and optimizes accumulated SOPs
  • Supports revised with no change filing
  • Develops new SOPs
  • Incremental updates

SOP Integration

Mergers and acquisitions are an integral part of today’s business scenario. But when they take place, bringing together and managing the procedures, standards, SOPs and quality systems of both the organizations could be gruelling. In addition to aligning the existing standards, setting up SOPs for newly formed organization will be even more hectic especially when it is to come into existence within short turnaround time.

Having an expert compliance team in-house, Freyr offers end-to-end SOP integration services to analyse the gaps between both the organizations’ systems, standardize existing systems and develop new SOPs if needed. Freyr experts extend full system integration support for designing seamless processes and workflows.

  • Integration and management of processes post acquisitions
  • SOP gap analysis
  • SOP standardization
  • SOP rationalization
  • SOP reconciliation and optimization
  • SOP integration

Freyr Advantages

  • Ensuring product quality, Regulatory compliance, patient safety, data integrity and security
  • Experienced and practicing professionals
  • Integrated process models
  • Effective and compliant business processes
  • Proven validation and qualification strategies
  • Quick turnaround timeframes (TAT)
  • Significant cost savings