© 2018 by STEP-IN Management Ltd.

Accelerated SOP production

STEP-IN Management has developed a set of tools to aid and accelerate the production of SOPs and Associated Documents.  We work with clients to adopt and apply this methodology and/or provide Master Classes so clients can drive and maintain an SOP transformation program themselves.

It starts with the SOP Landscape - based on both our experience and norms identified across multiple pharma. A baseline for clients to establish their own vision of their optimal target set of SOPs.

SOP Planning tools set the scope and touch points for each topic, provide discipline during development and deter duplication and gaps across the set. They also look ahead to impact and implementation.

SOP Development tools build from the planning and enable speedy construction of the initial process map including identification of where process and guidance are better placed in Associated Documents. The methodology encourages unambiguous, brief language and separates out process exceptions from the standard. A summary at the start of the SOP (usually a single page) gives context and highlights key issues for users.

Implementation Planning captures the novelty, impact and complexity identified during planning and development. It documents communication and training plans, provides insights for training materials and allows nuanced curriculum population so avoiding the unpopular, blanket Read and Apply.

STEP-IN Management Associates have all worked in pharma and we keep the person doing the job in mind. We believe SOPs should make it easy for users to get it right; not set impractical hurdles or blur the message with 'legalese'.  SOPs we help produce are your SOPs for your people in your culture. Yes, we have building blocks, examples and know-how but we will not present you with a 'one size fits all' set and ownership remains with you.